By Steve Reinberg: HealthDay Reporter

TUESDAY, June 30 (HealthDay News) -- The popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, should be banned, and the maximum dose of over-the-counter painkillers with acetaminophen, like Tylenol or Excedrin, should be lowered, a U.S. Food and Drug Administration advisory panel urged Tuesday.

The panel's recommendations followed the release of an FDA report last month that found severe liver damage, and even death, can result from a lack of consumer awareness that acetaminophen -- which is easier on the stomach than such painkillers as aspirin and ibuprofen -- can cause such injury.

The dangers from use or abuse of Vicodin and Percocet may be even more concerning, one key panelist said.

"It seems to me that problems with opiate combinations are clearly more prevalent," Dr. Lewis S. Nelson, chairman of the FDA's Drug Safety and Risk Management Advisory Committee, said during a Tuesday press conference held after the two-day meeting.

Explaining the panel's 20-17 vote to ban prescription acetaminophen/opiate drugs, Nelson said, "There are many deaths that relate to problems with prescription opiate combination acetaminophen products, whereas the number of deaths clearly related to the over-the-counter products are much more limited."

But the FDA advisers also took aim at over-the-counter (OTC) acetaminophen products. The agency's report found that many people may consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks. Consumers may also not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.

Based on that, the FDA advisory panel voted 21-16 to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams -- equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.

The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.

The advisers voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu, which contain acetaminophen and other ingredients that treat cough and runny nose. Patients often mix the cold medications with pure acetaminophen drugs, like Tylenol, leaving them vulnerable to dangerously high levels of acetaminophen.

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.

Dr. Sandra L. Kweder, deputy director of the FDA's Office of New Drugs at the Center for Drug Evaluation and Research, gave a strong hint of what the agency might do with the advisory panel's recommendations.

"I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen, both for over-the-counter products and also prescription combination products," Kweder said during the press conference.

She added, "There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminophen combination products. If we don't eliminate these combination products, we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products."

At the very least the agency should require new warning labels on these prescription combinations that alert patients to the potential of liver damage if they take too much acetaminophen, she said.

Speaking for the OTC drug industry, Lynda A. Suydam, of the Consumer Healthcare Products Association (CHPA), said her group was "pleased the committee did not recommend eliminating these important nonprescription products."

However, in a statement, she added that CHPA was "disappointed in [the panel's] divided vote to lower the maximum daily dose and the single dose of 1000 mg acetaminophen. There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms."

Another expert took a different view. Dr. John H. Klippel, chief executive officer of the Arthritis Foundation, said Tuesday's votes were very important to "people with arthritis because acetaminophen is a very commonly used medication to control pain."

"Lowering the maximum dose, providing that kind of guidance to patients, if it increases safety, would be something the arthritis community would support," he said. "Every person who takes this drug sees it as valuable, but they want clear guidance so they won't be harmed by the drug."

Dr. Lewis W. Teperman, director of transplant surgery and vice chairman of surgery at New York University School of Medicine, said he also supported the panel's decision to recommend lowering doses of acetaminophen.

"It's not that the doses can get you in trouble, but the very young and the very old can get into trouble easily," he said. Also if you are sick, there is the danger of taking cold remedies that contain acetaminophen plus taking pure acetaminophen drugs as well, he noted.

But Klippel added that the vote to make the 1,000-milligram dose of acetaminophen available by prescription only would overburden the health-care system. "Given the massive number of people who rely on this drug for pain control, making the maximum dose requiring a prescription, I think, is going to place undue burden on the health-care system," he said.

Teperman disagreed.

"The 1,000 milligram pill should never be at the patient's discretion. It should only be prescribed by a physician," Teperman said. "If you took an entire bottle of Tylenol Extra Strength, three days later you would be in a coma and needing a liver transplant."More information

SOURCES: June 30, 2009, press conference with Sandra L. Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Lewis S. Nelson, M.D., chairman, FDA Drug Safety and Risk Management Advisory Committee, and associate professor, department of emergency medicine, NYU Langone Medical Center; John H. Klippel, M.D., CEO, Arthritis Foundation; Lewis W. Teperman, M.D., director of transplant surgery, vice chairman of surgery, New York University School of Medicine, New York City; June 30, 2009, news release, Consumer Healthcare Products Association; May 28, 2009, news release, U.S. Food and Drug Administration

By Steven Reinberg: HealthDay Reporter

WEDNESDAY, July 1 (HealthDay News) -- Two drugs prescribed to help people quit smoking, Chantix and Zyban, will now carry "black-box" warnings on the potential risks of psychiatric problems, including depression and suicidal thoughts, U.S. health officials said Wednesday.

The U.S. Food and Drug Administration said it was mandating the black-box warnings, the strictest possible, based on reports to the agency of these side effects and on a review of clinical trials and scientific literature.

"We are requiring the manufacturers of the smoking-cessation drugs Chantix and Zyban to add a new boxed warning highlighting the risk of serious mental health symptoms with use of these products," Dr. Curt Rosebraugh, director of the FDA's Office of Drug Evaluation II, said during a Wednesday teleconference.

The agency's review found that some people who used Chantix (varenicline) and Zyban (bupropion) experienced unusual changes in behavior, became depressed, or had their depression worsen and had thoughts of suicide or dying, the FDA said.

Dr. Curt Rosebraugh said there were reports of 98 suicides and 188 suicide attempts involving Chantix, and 14 suicides and 17 attempts reported with Zyban.

For many users, the problems started soon after they began taking the drugs and ended when they stopped taking them. Some users, however, continued to have symptoms even after stopping the drugs. In a few cases, the problems started after the drugs were stopped, Rosebraugh said.

People taking these drugs who develop any of these symptoms should be monitored until their symptoms clear up, even if symptoms develop after stopping these drugs, Rosebraugh added.

The drugs don't contain nicotine, and some of the symptoms may be caused by nicotine withdrawal. People who stop smoking can suffer from depression, anxiety, irritability, restlessness, and sleep disturbances, the FDA noted.

Some patients who were using the drugs experienced the side effects while they were still smoking, the agency said.

Rosebraugh said the risk of using these drugs needs to be balanced with the substantial benefits of quitting smoking, and these drugs can be very effective.

"Stopping smoking is a goal we all want to work towards, and if people need medication to do it they should have access to it. So we don't want to scare people off from trying to use a medication to stop smoking; we just want them to be carefully monitored," he said.

In addition to the warning, the FDA is requesting more prescribing information in the warning section of the label, and new information in the Medication Guide for patients that discusses the risk of mental health events while using these products.

The makers of the drugs will also be required to do a clinical trial to see how often serious psychiatric symptoms occur in patients using a variety of therapies to help them quit smoking, including patients who currently have psychiatric disorders, Rosebraugh said. Results of this trial won't be known for several years, he added.

Chantix is manufactured by Pfizer Inc. Zyban is made by GlaxoSmithKline.

"The labeling update underscores the important role of health-care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely," Dr. Briggs W. Morrison, senior vice president for the Primary Care Development Group at Pfizer, said in a prepared statement. "Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex."

The FDA's review of consumers using nicotine patches did not find a link between patches and psychiatric side effects.

The antidepressant Wellbutrin, which contains the same active ingredient as Zyban, already carries a black-box warning.More information

SOURCE: July 1, 2009, teleconference with Curt Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, U.S. Food and Drug Administration

WEDNESDAY, July 1 (HealthDay News) -- The more alcohol men drink, the more time they spend in a hospital, research from the United Kingdom has found.

The study, which involved nearly 6,000 men in Scotland ages 35 to 64, began during the early 1970s. Initially, the men were given a comprehensive health examination and were asked about their alcohol consumption. Based on their answers, they were placed in different groups: no alcohol, 1 to 7 units a week, 8 to 14 units a week, 15 to 21 units a week, 22 to 34 units a week and 35 or more units a week or more.

A unit of alcohol, or an average drink, was considered to be half a pint of beer (about a cup) or a 4-ounce glass of wine, for example, according to the study.

The researchers tracked the men's health for an average of 28 years, focusing on the occurrence of heart and respiratory diseases, stroke and alcohol-related illnesses and conditions.

Men who drank more than 22 units of alcohol a week had a 20 percent higher hospital admission rate than non-drinkers, the study found.

Even relatively low levels of alcohol consumption were associated with a higher number of days spent in the hospital, the researchers found. Drinkers of eight or more units of alcohol a week were hospitalized more days than non-drinkers, and the length of stay increased as weekly consumption of alcohol went up.

The heaviest drinkers spent 58 percent longer in a hospital than non-drinkers, according to the study.

The study, published online in the Journal of Epidemiology and Community Health, also found that:

SOURCE: BMJ Specialist Journals, news release, July 1, 2009

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FRIDAY, June 26 (HealthDay News) -- A direct link exists between smoking and brain damage, researchers say.

The scientists found that a compound in tobacco triggers white blood cells in the central nervous system to attack healthy cells, resulting in severe neurological damage.

The compound, NNK, is a procarcinogen, which means it becomes cancer-causing when it's altered by the metabolic processes of the body, the researchers wrote. NNK doesn't cause direct harm to brain cells, but appears to cause neuroinflammation that leads to disorders such as multiple sclerosis.

Scientists at the National Brain Research Center in India found that NNK increases stress-related proteins such as pro-inflammatory signaling proteins and pro-inflammatory effector proteins, as well as pro-inflammatory cytokines, which act as molecular messengers between cells.

This demonstrates that NNK triggers an exaggerated response from the brain's immune cells, called microglia. Normally, microglia cells attack damaged or unhealthy cells, but when provoked by NNK, they attack healthy brain cells, the researchers added.

"Our findings prove that tobacco compound NNK can activate microglia significantly, which subsequently harms the nerve cells," lead researcher Dr. Anirban Basu said in a news release.

The study appears in the July issue of the Journal of Neurochemistry.

Since NNK is present in all tobacco products, it can also enter the body by chewing, the researchers noted. Secondhand smoke also contains high levels of NNK and can have a harmful effect on the brain, they said.More information

-- Robert Preidt

SOURCE: Journal of Neurochemistry, news release, June 23, 2009

By Serena Gordon: HealthDay Reporter

MONDAY, June 29 (HealthDay News) -- Being a diabetic and having just one episode of low blood sugar during a hospital stay was associated with a significantly increased risk of dying, both in the hospital and up to a year later, new research shows.

In a study that included almost 2,600 people with diabetes who were hospitalized for a variety of ailments, researchers found that low blood sugar (hypoglycemia) occurred in nearly 8 percent of the patients, and that each additional day with a hypoglycemic episode was associated with an 85 percent increase in the risk of death while hospitalized. The study also found a 66 percent increased mortality risk for one year following discharge in patients who'd had hypoglycemia.

"We think hypoglycemia likely was a marker for severity of illness," explained study author Dr. Alexander Turchin, an assistant professor of medicine at Harvard Medical School and an associate physician at Brigham and Women's Hospital in Boston. "A patient gets admitted to the hospital, becomes more ill and stops eating. If they're using the same anti-diabetes regimen they do at home, they'll develop hypoglycemia."

Results of the study were published in the July issue of Diabetes Care.

Because high blood sugar levels are associated with numerous adverse health outcomes, researchers began investigating if lowering high blood sugar levels in critically ill patients would improve outcomes. An initial study found positive results for aggressively lowering blood sugar. However, since that time several studies have questioned this practice because they found an increased risk of mortality, possibly due to lowering blood sugar too much.

Most of the research was done in patients in intensive care, but the current study focuses on people hospitalized in the general wards for numerous different reasons -- from elective surgeries to infectious diseases.

Turchin and his colleagues analyzed data from 4,368 non-critical hospital admissions. Of these, 2,582 were people with diabetes -- both type 1 and type 2. About one-third of the people with diabetes received treatment with insulin.

Hypoglycemia was defined as a blood sugar reading of less than 50 milligrams per deciliter (mg/dl). The researchers found that 7.7 percent of the hospitalized people with diabetes had at least one episode of low blood sugar.

The researchers controlled the data for a number of factors, including the presence of other illnesses, and predicted what a normal length of stay for that condition should be.

"Even after including all of that, low blood sugar still gave us additional information about the prediction of mortality that we're not capturing with all the other metrics," said Turchin.

The risk of inpatient death jumped 85.3 percent for each additional day with hypoglycemia, the team found. Up to one year later, the risk of death was still increased by 65.8 percent for each additional day someone experienced hypoglycemia. The researchers also found that the length of a hospital stay increased by 2.5 days for each day there was at least one low blood sugar reading.

"If patients develop low blood sugar, they should be closely monitored for clinical deterioration," said Dr. Alexander Turchin. "Keeping blood sugar high doesn't have a benefit, but being too aggressive in lowering it may not be such as a good idea either."

Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said that his sense is that the higher risk of mortality in people with hypoglycemia is a result of underlying disease, rather than from aggressive treatment.

"There's no question that hypoglycemia is associated with a high mortality rate, but it's an association; there's no direct evidence of causality," he said.

Turchin said the researchers weren't able to do a comprehensive analysis to determine if a hypoglycemic episode that occurred for an obvious reason -- such as a late meal in someone who's been given insulin -- had the same increased risk that a spontaneously occurring low blood sugar episode did.

No matter what the cause, however, Turchin recommended that these patients be "more closely monitored to prevent low blood sugar, which can only exacerbate their problems."More information

SOURCES: Alexander Turchin, M.D., assistant professor, medicine, Harvard Medical School, and associate physician, Brigham and Women's Hospital, Boston; Joel Zonszein, M.D., director, clinical diabetes center, Montefiore Medical Center, New York City; July 2009 Diabetes Care

By Steven Reinberg: HealthDay Reporter

FRIDAY, June 26 (HealthDay News) -- Fat from red meat and dairy products can increase your risk for pancreatic cancer, researchers from the U.S. National Cancer Institute report.

Pancreatic cancer, which is usually fatal, is the fourth-leading cause of cancer deaths in the United States. Various risk factors for developing the disease have been identified, including smoking, diabetes and obesity. Some studies have also linked dietary fat to increased risk, but researchers said that data had been inconclusive.

However, Rachael Z. Stolzenberg-Solomon, from the institute's cancer epidemiology and genetics division, said the new study "found an association between high fat intake and pancreatic cancer risk -- specifically, high fat from animal foods."

"These findings are in line with the dietary guidelines for Americans to reduce the amount of fat they eat," she said. "Reducing fat may reduce the risk of pancreatic cancer."

The report is published online June 26 in the Journal of the National Cancer Institute.

The researchers collected data on more than a half-million people -- 308,736 men and 216,737 women -- who participated in the National Institutes of Health-AARP Diet and Health Study. All participants completed a 124-item food questionnaire in 1995 and 1996.

During an average of six years of follow-up, 1,337 people were diagnosed with pancreatic cancer. Men who consumed the most fat from animal sources had a 53 percent increased risk of developing pancreatic cancer and women had a 23 percent increased risk, compared with men and women who ate the least fat, the study found.

Dr. Brian M. Wolpin, and oncologist at the Dana-Farber Cancer Institute in Boston and co-author of an accompanying journal editorial, said the study might provide clues to the disease.

"We know very little about pancreatic cancer and what the causes are, and we don't do a very good job treating it," Wolpin said.

He noted that in addition to the possibility of a link between pancreatic cancer and fat, there are other good reasons to limit consumption of red meat and animal fat, including an increased risk for other cancers.

People who eat a lot of red meat tend to engage in other unhealthy lifestyle behaviors, Wolpin said. "Whether it's red meat or a constituent of red meat or your overall lifestyle that matters, these studies cannot tease out to a convincing extent," he said. "But it's clear that lifestyle does impact this disease."

Eric J. Jacobs, strategic director of pharmacoepidemiology at the American Cancer Society, said that the study "provides important evidence that a diet high in animal fat may increase risk of one of the leading causes of cancer death."

"While further confirmatory research about animal fat and pancreatic cancer is still needed, results of this study support the American Cancer Society's recommendations to limit red meat and emphasize plant foods to help reduce risk of a variety of cancers," Jacobs said.

In addition to diet, weight appears to be a risk factor for pancreatic cancer.

Research reported in the June 24 issue of the Journal of the American Medical Association found that being overweight or obese as a young adult increases the risk for pancreatic cancer, and obesity in middle age is linked with poorer survival from the disease.

Being overweight in your 30s was associated with a 60 percent increased risk for pancreatic cancer, and being obese was associated with a twofold to threefold higher risk, the researchers found.

"Something associated with obesity apparently drives pancreatic cancer," said Dr. Robert R. McWilliams, an oncologist at the Mayo Clinic and co-author of a JAMA editorial on the study. "As a scientific community, we need to understand the underlying mechanism. Hopefully, this can lead to future treatment strategies."More information

By Jennifer Thomas: HealthDay Reporter

MONDAY, June 29 (HealthDay News) -- Countries that received the most airline passengers from Mexico this spring were the most likely to see H1N1 swine flu infection, new research says.

The finding confirms that tracking global flight patterns to determine where an infectious disease may strike next could provide governments and public health officials with a means of preventing and dealing with such threats, according to an analysis by researchers in Canada.

"Infectious diseases don't respect national boundaries, and we live in an incredibly interconnected world," said Dr. Kamran Khan, an infectious disease physician and scientist at St. Michael's Hospital in Toronto. "Yet, infectious diseases do follow airline flight routes. If we can understand how people move around the world, we can understand how infectious diseases are likely to spread around the world."

The findings were published online June 29 in a letter to the editor in the New England Journal of Medicine.

Using an extensive database of global air traffic and passenger itineraries, the research team analyzed information on 2.35 million passengers traveling from Mexico to more than 1,000 cities in 164 nations in March and April 2008. Swine flu emerged this spring, but because passenger data from 2009 was not yet available, the investigators used 2008 flight information, noting that air travel patterns in March and April change little from year to year.

From Mexico, nearly 81 percent of air passengers flew to the United States or Canada, while 8.8 percent went to Central America, South America or the Caribbean Islands, 8.7 percent flew to Western Europe, 1 percent went to East Asia and 0.8 percent flew elsewhere, the researchers found.

The United States received the bulk of passengers from Mexico, with about 1.74 million arrivals, followed by Canada with 149,137 arrivals, France with 47,501, then Spain, Germany, Cuba, Argentina, Italy, Brazil, Guatemala, United Kingdom, Colombia, Japan, Chile, Venezuela, Panama, Costa Rica, Netherlands, Peru and Switzerland.

Cities receiving the most arrivals from Mexico were Los Angeles, New York, Chicago, Miami, Houston and Minneapolis-St. Paul.

Of the top-20 destination countries, only one -- Venezuela -- had no confirmed cases of swine flu as of May 25, 2009. Japan, Chile and Peru had confirmed swine flu cases, but there was no known association with travel to Mexico, according to the correspondence.

All of the others had confirmed cases of swine flu related to travel from Mexico as of May 25.

"The traffic was so strongly correlated with the importation of this disease," Dr. Kamran Khan said. "Where people go, infectious diseases of people will follow."

Conversely, the nations that were not among the top-20 destinations for passengers from Mexico had few or no cases of travel-associated swine flu.

"Almost all the imported cases were in the countries with high-traffic volumes of passengers from Mexico," Khan said. "Almost no importations were in the countries with low-traffic volumes."

On June 11, the World Health Organization declared swine flu a pandemic as infections climbed across North America, Australia, South America, Europe and elsewhere. An estimated one million Americans have been infected with the H1N1 swine flu, though in most people symptoms are mild, according to U.S. health officials.

The database used in the study, called the Bio.Diaspora Project, includes world air-travel patterns that represent 99 percent of the world's commercial air traffic, Khan said. The information, which was collected with the cooperation of several international airport and airline associations, includes itineraries from 2.2 billion passengers and flight schedules from 3,500 airports in about 250 nations and territories worldwide dating to January 2000.

Researchers plan to use the database, which does not connect itineraries with specific passenger names, to help determine where newly emerging infectious diseases are most likely to turn up.

In doing so, governments and public health authorities could work together to prevent the spread of disease and take steps such as determining where to marshal limited public health resources.

"We can't address all threats everywhere, but we can put all of our resources into locations where there is the greatest risk," Khan said.

Though the study shows how air travel contributes to the rapid spread of a disease, it's still unknown if travel information would help slow the spread of an emerging infectious disease, said Dr. Lisa Winston, an assistant clinical professor of medicine in the division of infectious diseases at the University of California, San Francisco Medical School.

Many diseases have already spread around the globe before epidemiologists and scientists learn of them, Winston said.

"It can be difficult to figure out where it started. Things can feel like they are popping up in different places," Winston said. "It's very difficult to control a disease that is very infectious."More information

SOURCES: Kamran Khan, M.D., infectious disease physician and scientist, St. Michael's Hospital, Toronto, Canada; Lisa Winston, M.D., assistant clinical professor of medicine, division of infectious disease, University of California, San Francisco Medical School; June 29, 2009, New England Journal of Medicine, online

TUESDAY, June 30 (HealthDay News) -- Millions of people suffer from tendinitis of the rotator cuff, but a minimally invasive procedure can significantly reduce their pain and restore mobility of the shoulder, Italian researchers say.

Their study included 287 patients with calcific tendinitis, which involves small calcium deposits within the tendons of the rotator cuff in the shoulder. The patients were randomly assigned to receive ultrasound-guided percutaneous (through the skin) therapy (219 patients) or to a control group that didn't receive treatment (68 patients). Follow-up was conducted after one month, three months, one year, five years and 10 years.

During the 20-minute procedure, a radiologist uses ultrasound guidance to inject a saline solution into the rotator cuff to wash the affected area and break up calcium deposits.

Compared to patients in the control group, those who received treatment showed a considerable reduction in pain and improved mobility after one month, three months and one year. After five and 10 years, both groups of patients showed similar improvement, the researchers found.

The study appears in the July issue of the journal Radiology.

"With this treatment, we were able to establish a single inexpensive and effective treatment for calcific tendinitis of the rotator cuff. This has never happened before," study co-author Dr. Luca M. Sconfienza of the University of Milan School of Medicine, said in a news release from the Radiological Society of North America. "This treatment could completely replace other treatments that are affected by several limitations and complications."

In minor cases of calcific tendinitis of the rotator cuff, physical therapy or anti-inflammatory drugs may help reduce symptoms until the calcium deposits break apart on their own. Shockwave therapy or open surgery to remove the calcium may be required in severe cases. Open surgery involves hospitalization, rehabilitation and, in some cases, can cause major complications, such as tendon rupture, according to background information in the news release.More information

-- Robert Preidt

SOURCE: Radiological Society of North America, news release, June 30, 2009

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FRIDAY, June 26 (HealthDay News) -- A new drug to treat rheumatoid arthritis reduces joint inflammation in severe cases while causing only mild to moderate side effects, according to a report from the first clinical trial of the drug on humans.

Masitinib, which is being developed by AB Science pharmaceuticals, is supposed to halt the activity of mast cells, a part of the immune system believed to be involved in the start and progression of rheumatoid arthritis.

The results of the French trial, involving 43 people with arthritis that other treatments had failed to help, appears online in Arthritis Research and Therapy.

"We are encouraged from this study that masitinib not only appears to be effective, but that within the first three months of treatment, the worst of its side effects were over, possibly making it suitable for long-term treatment regimens," one of the researchers, Olivier Hermine, said in a news release from the journal's publisher. The next step will be placebo-controlled trials, he added.More information

-- Kevin McKeever


SOURCE: BioMed Central, news release, June 26, 2009

By Steven Reinberg: HealthDay Reporter

FRIDAY, June 19 (HealthDay News) -- U.S. health officials are warning consumers not to eat any Nestlé Toll House refrigerated cookie dough products because of the risk of E. coli contamination.

In response to the Food and Drug Administration warning, Nestlé USA said Friday that it was voluntarily recalling its Toll House refrigerated cookie dough items.

"The E. coli outbreak could be from one or a number of contaminates, such as the milk component, the machinery, even the harvested flour," said one expert in infectious disease, Dr. Philip M. Tierno, director of clinical microbiology and immunology at New York University Langone Medical Center.

"Whether eaten or handled (causing cross-contamination), the dough is a danger, especially to the elderly, anyone with a suppressed immune system or pregnant women and should be discarded,"Dr. Philip M. Tierno said.

Since March there have been 66 reports of illness in 28 states, the agency said. Twenty-five people have been hospitalized, seven with a severe complication called hemolytic uremic syndrome, which can result in kidney damage and even death. There have been no deaths, the FDA said.

The FDA is advising consumers to toss out any refrigerated Nestlé Toll House cookie dough products they have in their homes. The agency also says not to cook the dough because E. coli bacteria could get on your hands and cooking surfaces, leading to cross-contamination.

Retailers, restaurateurs, and other food-service operations should not sell or serve any Nestlé Toll House refrigerated cookie dough, the agency added.

The recall includes refrigerated cookie and brownie dough bar, cookie dough tub, cookie dough tubes, seasonal cookie and brownie dough, and Ultimates cookie bar dough. It does not include any other Toll House products, the company said in a news release.

Nestlé spokeswoman Roz O'Hearn said "this has been a very quickly moving situation," adding that the company took action less than 24 hours after hearing of the problem.

O'Hearn said the company will "cooperate fully" with the FDA's investigation, the Associated Press reported.

E. coli. can cause abdominal cramps, vomiting and diarrhea, often with bloody stools. Most healthy adults recover within a week. Young children and the elderly are at highest risk for developing hemolytic uremic syndrome, the FDA said.More information

SOURCES: Philip M. Tierno, M.D., director, Clinical Microbiology and Immunology, New York University Langone Medical Center, and clinical professor of microbiology and pathology, New York University School of Medicine, New York City; June 19, 2009, news release, U.S. Food and Drug Administration; Associated Press

The American Heart Association provides an image of an EKG and explains what it means.

By Ed Edelson
HealthDay Reporter

WEDNESDAY, June 24 (HealthDay News) -- A new Canadian study adds compelling support for current recommendations that people who first get clot-dissolving treatment for heart attacks should have artery-opening angioplasty as soon as possible afterward.

"This study strengthens the guideline recommendations," said Dr. Warren J. Cantor, an assistant professor of medicine at the University of Toronto and lead author of a report in the June 25 issue of the New England Journal of Medicine. "The original recommendation was based on a limited number of trials. This is the largest trial done to date looking at the strategy of doing angioplasty routinely after fibrinolysis [clot-dissolving therapy]. It confirms that it is a safe approach with no increase in major bleeding, and that patients do better when they undergo angioplasty."

Immediate angioplasty after a heart attack is best, but many medical centers are not equipped to do the procedure on an emergency basis, Cantor noted. "In most centers in the world, patients receive clot-busting medication," he said. "Many are routinely transferred to a center where they can undergo angioplasty."

The study shows that angioplasty should be done within six hours, Cantor said.

The study included 1,059 people who had major heart attacks and were given clot-dissolving treatment at Canadian medical centers not equipped for angioplasty. Half were assigned to standard treatment, clot-preventing drugs with aspirin and the blood thinner heparin, with angioplasty done when possible. The other half were transferred to centers where angioplasty could be done within six hours.

Nearly 90 percent of those getting standard treatment did have angioplasty, done after an average wait of more than 32 hours. Nearly all those transferred for quick angioplasty had it in less than three hours. After six months, 11 percent of those who had quick angioplasty had a major adverse cardiac event or died, compared to 17.2 percent of those assigned to standard treatment.

Guidelines of the American Heart Association and American College of Cardiology recommend the quick angioplasty strategy, but "the evidence for it was fairly limited until recently," Cantor said. "Older studies said there might be more harm than good, with major bleeding."

"That was true back then, but we are talking about a generation ago," said Dr. Jeffrey W. Moses, director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. "With stents and drugs like Plavix, the world has changed."

Stents are flexible metal tubes inserted to keep arteries open following angioplasty, and Plavix is a potent clot-dissolving drug.

Several studies have compared clot-dissolving therapy with angioplasty in the hours after a heart attack, "and angioplasty is better," Moses said. While statistics are vague, probably only half the people who suffer heart attacks in the United States get angioplasty as the first treatment, he said.

"If you get clot-busters, you should have angioplasty as soon as possible, at that site or somewhere else," Moses said.

The case for limiting heart attack treatment to clot-dissolving therapy has been lost, Cantor said.

"Recent studies using contemporary equipment suggested a much safer and effective treatment, and we confirm it in the largest trial yet done," he said.More information

SOURCES: Warren J. Cantor, M.D., assistant professor, medicine, University of Toronto; Jeffrey W. Moses, M.D., director, Center for Interventional Vascular Therapy, New York-Presbyterian Hospital/Columbia University Medical Center, New York City; June 25, 2009, New England Journal of Medicine

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, June 24 (HealthDay News) -- A new cancer drug called olaparib worked well in an early clinical trial against breast, ovarian and prostate cancers in individuals who were genetically vulnerable to developing these malignancies.

Women who carry BRCA1 and BRCA2 gene mutations are susceptible to developing breast and ovarian cancer, and among men these mutations are related to an increased risk for prostate cancer, the British researchers noted.

Olaparib works differently than other cancer drugs in that it blocks Poly(ADP-ribose) polymerase (PARP), a protein involved in DNA repair. Healthy cells use PARP to repair themselves, but cancer cells do the same, the scientists explained.

"This is an entirely new class of drugs," said Dr. J. Dirk Iglehart, from the department of surgery at Brigham and Women's Hospital and the department of cancer biology at the Dana-Farber Cancer Institute in Boston, and co-author of an accompanying journal editorial.

When you disable PARP, you prevent the cell from repairing itself, he said, and cancer cells that are deficient in BRCA are much more sensitive to this effect. "When you inhibit PARP, they can't stand it," Iglehart explained.

The report is published online June 24 in the New England Journal of Medicine.

In a phase 1 trial, led by Dr. Johann S. de Bono, from the Institute of Cancer Research at the Royal Marsden NHS Foundation Trust in Sutton, U.K., the scientists treated 60 men and women who were carriers of the BRCA1 or BRCA2 mutations, or had a family history of BRCA-related cancer, with olaparib. All of the patients had either breast, ovarian, prostate, colorectal, melanoma, sarcoma or other cancers.

In this group, there were only a few adverse side effects and they were easily reversed by lowering the dose of the drug, the study noted.

Next, de Bono's team tried the drug on a smaller group of patients, all of whom were confirmed carriers of the BRCA1 or BRCA2 mutation. Those patients received 200 milligrams of olaparib twice a day.

The researchers found that olaparib was absorbed quickly, was eliminated from the body quickly, and had mild side effects. In addition, among people with the BRCA mutations the drug shrunk tumors in breast, ovarian and prostate cancer.

"Olaparib has few of the adverse effects of conventional chemotherapy, inhibits PARP, and has anti-tumor activity in cancer associated with the BRCA1 and BRCA2 mutation," the team concluded.

Iglehart thinks that combining a PARP inhibitor with chemotherapy drugs that damage DNA might make the drug even more effective. "You might then push cancers over the cliff that would be only susceptible to a PARP inhibitor," he said.

In addition, "PARP inhibitors may be used for tumors that Herceptin or tamoxifen are totally incapable of treating," he said. "That's true for ovarian cancer, too. There is nothing to treat that disease."

Two other trials of PARP inhibitors, which were reported on during the American Society of Clinical Oncology annual meeting in June, also found that they were effective in treating breast cancer.

In one trial where PARP inhibitors were combined with standard chemotherapy, there was almost a doubling of survival -- from 5.7 months with chemo alone to 9.2 months when the PARP inhibitor BSI-201 was added, as well as about a 60 percent reduction in the risk of dying from the disease. There were also no additional side effects.

The second PARP inhibitor trial involved 54 women with advanced breast cancer who carried the BRCA mutations. In this trial, 41 percent of patients saw their tumors disappear. There was a slightly lower response rate in the lower-dose group. Mild nausea and fatigue were the most common side effects.

"The drugs are given orally, and it still remains a question as to whether the drugs' benefits will extend beyond this narrow patient population," noted Dr. Eric Weiner, chief of women's cancers at the Dana-Farber Cancer Institute.

"These two studies are very exciting," Dr. Kelly Marcom, a breast oncologist with Duke Comprehensive Cancer Center and director of the Duke Hereditary Cancer Clinic in Durham, N.C., said. "It speaks to a really clever understanding of the biology of the cancer."More information

SOURCES: J. Dirk Iglehart, M.D., department of surgery, Brigham and Women's Hospital, and the department of cancer biology, Dana-Farber Cancer Institute, Boston; Eric Weiner, M.D., chief, women's cancers, Dana-Farber Cancer Institute, Boston; Kelly Marcom, M.D., breast oncologist, Duke Comprehensive Cancer Center, and director, Duke Hereditary Cancer Clinic, Durham, N.C.; June 24, 2009, New England Journal of Medicine, online

FRIDAY, June 19 (HealthDay News) -- The smoke from cannabis, the plant from which marijuana is derived, contains compounds that can damage DNA and increase the risk of cancer just like tobacco smoke, says a new study from the United Kingdom.

In laboratory tests, Rajinder Singh from the University of Leicester and colleagues found certain carcinogens in cannabis smoke in amounts 50 percent greater than those found in tobacco smoke. They noted that light cannabis use could possibly prove to be even more damaging because cannabis smokers usually inhale more deeply than cigarette smokers.

"The smoking of three to four cannabis cigarettes a day is associated with the same degree of damage to bronchial mucus membranes as 20 or more tobacco cigarettes a day," the researchers noted in a news release from the university.

The research was based on tests using a new highly sensitive liquid chromatography-tandem mass spectrometry method to analyze the cannabis smoke. It looked specifically at acetaldehyde -- a suspected cancer-causing chemical known to affect human DNA that is found in both kinds of smoke.

"These results provide evidence for the DNA-damaging potential of cannabis smoke, implying that the consumption of cannabis cigarettes may be detrimental to human health with the possibility to initiate cancer development," the researchers concluded in their report, published in the June 15 issue of Chemical Research in Toxicology.More information

-- Kevin McKeever

SOURCE: University of Leicester, news release, June 16, 2009

By Serena Gordon: HealthDay Reporter

MONDAY, June 15 (HealthDay News) -- Stimulant medications commonly prescribed to treat attention-deficit hyperactivity disorder (ADHD) are associated with an increased risk of sudden death, but those deaths are still rare, new research finds.

Children and teens taking ADHD stimulant medications were seven times more likely to die suddenly than their peers, the study found.

"What we found -- to our surprise -- is that even if you take out confounding factors, the association between stimulant use and sudden death was still significant," said study author, Madelyn Gould, a professor of clinical epidemiology in psychiatry at Columbia University/New York State Psychiatric Institute in New York City. "I'm confident the association is real and significant, but it's very rare. I don't want our findings to change prescribing patterns or for a parent to change their willingness to use stimulant medications if they're called for, but physicians should monitor patients with any new medication they give a young person."

Results of the study were published in the June 15 online edition of the American Journal of Psychiatry.

As many as 2.5 million children in the United States take ADHD stimulant medications, such as amphetamine, dextroamphetamine (Adderall), methamphetamine or methylphenidate (Ritalin), according to an editorial in the same issue.

In the early 1990s, several reports of sudden, unexplained death in children taking these medications began to raise concerns. But the rarity of such deaths made them difficult to study. In 2006, the U.S. Food and Drug Administration requested that the prescribing information on these medications warn physicians against ordering the drugs for children with any known cardiac abnormalities. Current prescribing information also suggests that physicians request a thorough family history of heart problems and sudden deaths and perform a physical exam before starting youngsters on these medications.

Gould said the FDA approached her and her colleagues to try to assess the true prevalence of this problem.

The researchers sifted through mortality data from 1985 through 1996, and found 564 cases of sudden death that occurred in children aged 7 to 19, and they compared them to 564 youths who had been killed as passengers in automobile accidents.

After ruling out factors such as a history of known cardiac problems; known causes of death, such as asthma or an accidental death, and other conditions, such as sickle cell anemia or cerebral palsy, Gould and her colleagues found only 10 sudden, unexplained deaths in children taking stimulant medications.

When they compared those 10 youths to age-matched controls who had died in car crashes, they found that the odds of sudden death were 7.4 times higher for children taking stimulant medications.

"Stimulants do increase blood pressure, and there have been reports of them changing heart rates," noted Gould.

"This report is quite helpful," said one of the authors of the accompanying editorial, Dr. Benedetto Vitiello, a psychiatrist and chief of the child and adolescent treatment intervention branch at the U.S. National Institute of Mental Health. "It rings a bell for everyone to be more attentive and less cavalier about the use of these drugs."

Many teens and even some adults take them for non-approved uses, such as improving focus and enhancing performance at work or at school.

"We need to keep in mind that even though these drugs are commonly used, they still have the potential for adverse events. We shouldn't approach them lightly," said Vitiello.

Dr. Diego Chaves-Gnecco, a developmental-behavioral pediatrician at Children's Hospital of Pittsburgh, agreed with Vitiello.

"No medication is free of risk or side effects. Any time we prescribe any medication, we have to balance its benefits and risks," he said.

In the case of stimulant medications, Dr. Diego Chaves-Gnecco said physicians should follow recently developed guidelines and take a thorough personal and family history before prescribing them. If any concerns arise, the child should be referred for an EKG (a heart rate test) or an evaluation by a pediatric cardiologist before medication is prescribed.

If your child has been on stimulants for awhile, there's probably no need for concern, Gould said. Parents should not abruptly stop their child's medications, the three experts agreed. If you are worried, call the prescribing doctor and discuss the potential risks and benefits of the medications, because often the benefits will outweigh the risks.

"The most important point is to make sure that everyone is well-educated and that a conscientious screening has been done," said Chaves-Gnecco.More information

SOURCES: Madelyn S. Gould, M.P.H., professor, clinical epidemiology in psychiatry, Columbia University/New York State Psychiatric Institute, New York City; Diego Chaves-Gnecco, M.D., developmental-behavioral pediatrician, Children's Hospital of Pittsburgh, Penn.; Benedetto Vitiello, M.D., psychiatrist and chief, child and adolescent treatment intervention branch, National Institute of Mental Health, Bethesda, Md.; American Journal of Psychiatry online, June 15, 2009

By Steven Reinberg: HealthDay Reporter

FRIDAY, June 12 (HealthDay News) -- The U.S. Food and Drug Administration on Friday requested that the makers of a class of asthma drugs called leukotriene receptor agonists place a "precaution" on the drugs' labeling, warning of the potential for neuropsychiatric events.

The drugs in question include the blockbuster medication Singulair (montelukast), as well as Accolate (zafirlukast). Zyflo and Zyflo CR (zileuton), drugs in a class known as leukotriene synthesis inhibitors, are also included in the labeling change.

"The reported neuropsychiatric events include post market cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior [including suicide], and tremor," the agency said in a statement posted on its Web site Friday.

In its advice to patients, the FDA said that patients taking these medications should be aware of the potential hazard and talk to their doctor if some sort of neuropsychiatric problem occurs. Doctors may then decide to discontinue the medication, the agency said.

The move follows an ongoing FDA safety review of possible suicidal behavior among those taking asthma drugs. In early January, FDA officials said they had found no evidence of a link.

The agency, which began its review of the data in March 2008, said clinical trial data submitted by the manufacturers of Singulair, Accolate and Zyflo suggested the products are not associated with an increased risk of mood changes or suicidal behavior.

But, the agency also noted at the time that the trials were not designed to examine such behavior, and that the safety review would continue, probably for several more months.

That review ended last April, the FDA said. "The postmarket reports of patients on these medications included cases of neuropsychiatric events," according to the agency statement. "Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders [primarily insomnia] were reported more frequently with all three products compared to placebo."

According to Bloomberg News, Merck & Co submitted results from 41 placebo-controlled trials involving 9,929 patients treated with Singulair, which is the top-selling drug for people under 17 years old. One adult patient treated with Singulair had suicidal thoughts, and there were no suicides, according to the FDA report.

A spokeswoman for Merck told the AP Friday that the precaution is already included in Singulair's labeling; it will simply be moved from a section on side effects to a higher section on "precautions."

AstraZeneca submitted results from 45 placebo-controlled trials in which 7,540 patients were treated with Accolate. The FDA said one patient in an accompanying placebo group attempted suicide, and another thought about it. No Accolate patients reported any suicidal behavior. The FDA also said Cornerstone submitted information showing no suicidal behavior among Zyflo users.

A Merck executive told the AP in January that the company had turned over extensive records to the FDA.

"We still believe, after a thorough review of our clinical trial data and postmarketing event reports that the safety profile of Singulair hasn't changed," Dr. Scott Korn, vice president for clinical risk management, said at the time. "We look forward to discussions with the FDA after they've completed their work."

Before last year's review began, Merck had updated prescribing information for Singulair to include information on several adverse events including tremor, depression, suicidality (suicidal thinking and behavior) and anxiousness, according to the FDA.

When the review began, experts pointed out that while it was under way, asthma sufferers needed to determine with their doctors whether Singulair is the best treatment for them.

"[Patients need] to define what they're taking it for," said Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas. "In some instances, patients may be prescribed Singulair by itself for management of their asthma, and the expert panel guidelines recommend inhaled steroids as the drug of choice for management of asthma as the first line. So if they're still having problems with asthma, they should check with their prescribing physician regarding this."

Weldon said that he has not seen any increase in psychiatric problems with the drug, but that some patients had complained of nightmares after starting on Singulair.

"The physician really needs to review whether there are symptoms that have developed since patients started taking the medication, if there's an underlying depression that was there before medication started," added Dr. Rauno Joks, chief of the division of allergy and immunology at SUNY (State University of New York) Downstate in New York City. "Also, seasonal allergies in and of themselves can cause fatigue and lethargy, which makes it harder to assess, because those are some of the symptoms you have with depression."

Joks said he had seen headaches develop as a side effect of Singulair, but not psychiatric problems.

Leukotriene receptor antagonists target part of the body's inflammatory process. They are prescribed to treat asthma and the symptoms of allergic rhinitis, as well as to prevent exercise-induced asthma.More information

SOURCES: June 12, 2009, statement, U.S. Food and Drug Administration; Bloomberg News; Associated Press; David Weldon, M.D., assistant professor, internal medicine, Texas A&M Health Science Center College of Medicine, and director, Allergy and Pulmonary Lab Services, Scott & White, College Station; Rauno Joks, M.D., associate professor, clinical medicine, and chief of the division of allergy and immunology at SUNY (State University of New York)

By Amanda Gardner: HealthDay Reporter

TUESDAY, June 16 (HealthDay News) -- U.S. health officials on Tuesday warned consumers to stop using Zicam nasal cold remedy products because they can cause the loss of a sense of smell.

The specific products contained in the warning include Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids' Size.

"These products claim to reduce the duration of the common cold and severity of cold symptoms," Deborah M. Autor, director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration, said during a morning teleconference Tuesday. "Consumers should stop using these products immediately."

The kids' products have been discontinued, but consumers may still have them in their households and are advised to discard or return them, officials said.

The products' manufacturer, Matrixx Initiatives, also received a warning letter and "must provide FDA with a plan on how it will remove existing inventory from the marketplace," Autor said.

"We have asked Matrixx in a warning letter to stop marketing the products, and we intend to work with them to address the products on the market and, at the same time, warn consumers to stop using and discard or return them," Autor continued. "We expect to hear a plan from the company."

According to Autor, the products have been marketed as homeopathic remedies and, therefore, have not needed FDA approval as long as the company complied with certain labeling and manufacturing requirements.

Now, the FDA is essentially asking Matrixx to take the unusual step of recalling the product, and then filing for new drug approval.

"The next step is for the company to come in and seek FDA approval if they want to continue marketing the products," Autor said.

"While the company has done trials involving small numbers of patients, we believe there have not been enough patients exposed in those trials to detect infrequent adverse events," she said.

According to Dr. Charles E. Lee, medical officer in the division of New Drugs and Labeling Compliance in CDER's Office of Compliance, the agency has received more than 130 reports from people using one of these zinc-containing products about the loss of a sense of smell, also known as anosmia.

"The loss of the sense of smell is potentially life-threatening and may be permanent," Dr. Charles E. Lee said. "People without the sense may not be able to detect dangerous situations such as gas leaks, something burning in the house, or if food is spoiled before eating it. It also has a life-limiting effect, and can affect the livelihood of people in occupations where the sense of smell or taste is a crucial component."

Lee pointed out that, while the rate of adverse events seen here may not seem high, adverse events reports for over-the-counter drugs are historically low because consumers typically file their complaints with companies, not the FDA.

Until 2007, there was no requirement for makers of over-the-counter products to provide adverse event reports to the agency.

All reports of the latest problem have come from consumers and health-care providers, and Autor said the company has more than 800 adverse event reports related to the loss of sense of smell it has been asked to turn over to the FDA.

She declined to elaborate further on these reports, simply saying, "They have not been provided to the agency at this time."

Lee said the first reports of something amiss came in 1999, but seemed to speed up after 2004.

In 2006, Matrixx agreed to pay $12 million to settle several hundred lawsuits from consumers who claimed the zinc products had stripped them of their sense of smell. At the time, Matrixx said the settlements were not an admission of liability, the Washington Post reported.

According to Lee, both animal studies and historical medical literature indicate that zinc is actually toxic to the nerve receptors in the nose. Zinc was apparently used in the 1930s to try to prevent polio infection, he said.More information


SOURCES: June 16, 2009, teleconference with: Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration; and Charles E. Lee, M.D., medical officer, Division of New Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, FDA; Jan. 30, 2006, Washington Post

TUESDAY, June 16 (HealthDay News) -- A device designed to filter bacteria-produced toxins from the blood of patients with severe sepsis or septic shock appears to improve blood circulation and organ function and lower the risk of death, a preliminary study suggests.

Italian researchers tested whether using a polymyxin B fiber column -- an antibiotic-based hemoperfusion device -- with conventional therapy would improve patient outcomes. Polymyxin B is an antibiotic, and hemoperfusion is blood filtering to remove toxins.

The study included 64 patients with severe sepsis or septic shock who had emergency surgery for intra-abdominal infection. The patients were randomly selected to receive either conventional therapy or conventional therapy plus two sessions of polymyxin B hemoperfusion.

After 28 days, the death rate was 32 percent in the polymyxin B hemoperfusion group and 53 percent in the group that received conventional therapy alone.

The study appears in the June 17 issue of the Journal of the American Medical Association.

"Larger multicenter studies are indicated to confirm these encouraging findings in other patient populations," the Italian researchers wrote.

The therapy used in this study is common in Japan, but not in the United States, according to an accompanying editorial written by Dr. John A. Kellum, of the University of Pittsburgh Medical Center, and Dr. Shigehiko Uchino, of the Jikei University School of Medicine in Tokyo.

Even though preliminary, the findings "suggest a number of interesting hypotheses and should provoke further study. This is essential given the significant ongoing problem that sepsis represents," they wrote.More information

-- Robert Preidt

SOURCE: Journal of the American Medical Association, news release, June 16, 2009

FRIDAY, June 12 (HealthDay News) -- People who suffer heart damage after vascular surgery face a higher risk of dying within the next few years, even if they show no symptoms of heart problems, a new study has found.

Lack of symptoms is common, according to the researchers.

In the study, which involved 1,545 people who had elective vascular surgery, 284 were found to have heart damage after surgery. However, 75 percent of them were either asymptomatic or their symptoms were masked by postoperative pain or nausea, the study found.

The study was to be presented June 12 in Denver at the annual meeting of the Society for Vascular Surgery.

The researchers tested the cardiac troponin T (cTnT) levels of the study participants one, three and seven days after their surgery and when they were discharged. Elevated levels of cTnT, a protein key to cardiac muscle contraction, indicate heart damage.

After surgery, heart damage was found to have occurred in 213 people who showed no symptoms and 71 who had symptoms, according to the researchers.

"Patients undergoing major arterial vascular surgery because of atherosclerotic disease are at high-risk for cardiac complications in the perioperative period," Dr. Olaf Schouten of the Erasmus Medical Center of Rotterdam, the Netherlands, said in a news release from the society.

"It is estimated that one out of five patients undergoing major vascular surgery suffers cardiac damage around the time of the operation if patients are appropriately screened in the first week after surgery," Dr. Olaf Schouten added. "Screening is a valuable tool to determine how aggressive medical therapy should be for their long-term prognosis."

During 3.7 years of follow-up, 40 percent of those with asymptomatic cardiac damage died, compared with 13 percent of people without cardiac damage. After adjusting for the type of surgery and known risk factors such as diabetes, heart failure and heart attacks, people with cardiac damage had more than twice the risk of dying in the years shortly after surgery, the study reported..

"Asymptomatic cTnT release, without clinical symptoms or new ECG changes, is associated with an increased long-term mortality in patients undergoing vascular surgery," Schouten concluded.More information

-- Jennifer Thomas

SOURCE: Society for Vascular Surgery, news release, June 11, 2009

By Ed Edelson: HealthDay Reporter

MONDAY, June 15 (HealthDay News) -- People with psoriasis face an increased risk of major cardiovascular disease and death, a new study finds.

The research, which included data from a Veterans Administration medical facility study to compare 3,236 people suffering from the skin disease to 2,500 psoriasis-free individuals, found a 78 percent higher incidence of heart disease, a 70 percent higher incidence of stroke and a 98 percent higher incidence of peripheral arterial disease (blockage of arteries in the legs) in the psoriasis group.

The overall death rate for those with psoriasis was 86 percent higher than for those without the disease. In the 20 years covered by the study, 19.6 percent of those with psoriasis died, compared to 9.9 percent of those without the disease.

The cardiovascular disease calculations included effects of known risk factors such as obesity, smoking, diabetes and high blood cholesterol, said study co-author Dr. Robert S. Kirsner, vice chairman of dermatology at the University of Miami Miller School of Medicine. The team reports the finding in the June issue of the Archives of Dermatology.

"In and of itself, psoriasis imparts a risk of cardiac disease, stroke and peripheral arterial disease," Kirsner said. "Psoriasis imposes the same level of risk as high blood lipids and smoking."

The risk appears to stem from the chronic inflammation associated with psoriasis, said Dr. Robert S. Kirsner. "This systemic inflammation causes damage to blood vessels, leading to increased risk," he said.

The medical lesson of the study is that "it is critical for people who have psoriasis to understand their increased risk and have their other risk factors addressed," he said.

Cardiovascular risk is linked to the severity of the skin disease, Kirsner said, and "there are some data suggesting that treating psoriasis can lower the risk."

However, the data are only suggestive, noted Dr. Joel M. Gelfand, medical director of the University of Pennsylvania's department of dermatology clinical studies unit, which has published several reports showing the same association.

One of his group's studies, using British data, found a 55 percent increased cardiovascular risk and a 78 percent higher death rate in persons with psoriasis, Gelfand said. "But we don't have enough data to know if controlling psoriasis would also control those risks," he said. "This is a key public health question best answered in a randomized, controlled trial."

Like Kirsner, Gelfand stressed the need to address traditional cardiovascular risk factors in people with psoriasis. "Patients who have psoriasis, especially severe cases, should be screened for modifiable risk factors," Gelfand said. "We have a plan in place for our patients to achieve a healthy lifestyle, a plan that includes weight control and exercise."

Psoriasis affects 2 percent to 3 percent of the world's population, including 7 million Americans, the new report estimated.More information

SOURCES: Robert S. Kirsner, M.D., Ph.D., professor and vice chairman, dermatology, University of Miami Miller School of Medicine; Joel M. Gelfand, M.D., medical director, University of Pennsylvania department of dermatology clinical studies unit, Philadelphia; June 2009 Archives of Dermatology

By Steven Reinberg: HealthDay Reporter

WEDNESDAY, June 17 (HealthDay News) --The new anti-clotting pill rivaroxaban (Xarelto) lowers the risk of stroke, heart attack and death in patients who have had a heart attack or suffer from unstable angina, a new trial shows.

Rivaroxaban is a pill that blocks factor Xa, which is involved in blood clotting. In earlier studies, the drug was effective in preventing venous thromboembolism (blood clots in the legs) after orthopedic surgery, although some increased risk in bleeding episodes was seen. In this phase II trial, researchers tested the safety and efficacy of the drug at various doses.

"The use of an oral factor Xa inhibitor in patients stabilized after an acute coronary syndrome increases bleeding in a dose-dependent manner, and might reduce major ischemic outcomes," said lead researcher Dr. Jessica L. Mega, from the Cardiovascular Division at Brigham and Women's Hospital in Boston. "On the basis of these observations, a phase III study of low-dose rivaroxaban as adjunctive therapy in these patients is underway."

The report is published in the June 17 online edition of The Lancet.

In March, a U.S. Food and Drug Administration advisory panel voted 15-2 that rivaroxaban, a long-sought alternative to commonly used blood thinners that have to be injected and are tricky to monitor, had benefits that outweighed its bleeding risks. Although the FDA is not bound by the panel's decision, it typically follows suit on these recommendations.

For the study, Mega's group treated 3,491 patients who had had heart attacks or unstable angina with either aspirin or aspirin plus the anti-clotting drug clopidogrel (Plavix).

The patients were then randomly assigned to a placebo or rivaroxaban, at doses ranging from 5 milligrams to 20 milligrams a day. The researchers looked for any significant bleeding and deaths, heart attacks and stroke.

There was an increase in bleeding episodes with rivaroxaban. Over six months, the researchers found that risk increased with dosage. At 5 milligrams, the risk increased 2.2 times, while the 20-milligram dose raised the risk fivefold.

However, patients receiving rivaroxaban had a 21 percent reduction in heart attacks, strokes, ischemic events and deaths compared with patients taking placebo. For heart attack, stroke and death alone, the risk was reduced by 31 percent compared with placebo, the researchers found.

"In this study, rivaroxaban was associated with a dose-dependent increase in clinically significant bleeding events, with a trend towards a reduction in the primary efficacy endpoint of death, myocardial infarction, stroke or severe recurrent ischemia requiring revascularization," Mega and colleagues wrote. "Regarding the main secondary efficacy endpoint, rivaroxaban reduced the rate of death, myocardial infarction or stroke."

Dr. Hitinder S. Gurm, from the University of Michigan Cardiovascular Center and co-author of an accompanying journal editorial, said the study showed no benefit in patients who are using aspirin and Plavix, although there was a suggestion of a benefit when the drug was used with aspirin alone.

"This study was a dose-finding study; it would be premature to assess the future of this drug in patients with acute coronary syndrome based on this trial, and the little bit of data that we have does not suggest the drug would provide a major benefit in patients who are already on contemporary therapy -- with the caveat that we need a larger trial to confirm or refute this," Gurm said.

Dr. Richard C. Becker, director of the Cardiovascular Thrombosis Center at Duke University Medical Center, said this study is another step in the search for an anti-clotting drug to replace warfarin for many patients. Warfarin is an effective drug, but requires constant monitoring to assure that patients are receiving a dose that is not too low, which is ineffective, or too high, which increases the risk of bleeding.

"The trends toward benefit with rivaroxaban, as a fixed-dose, direct and oral factor Xa inhibitor, provide a sound rationale to pursue a path of further investigation," Becker said.

The dose-related bleeding risk supports a strategy of lower doses than would be used for other potential indications for the drug, such as atrial fibrillation and venous thrombosis, he said.

"In the next several years, the field will have a wealth of information on antithrombotic therapies, providing a platform to determine optimal treatment in a wide range of patients with acute coronary syndrome," Becker said.More information

SOURCES: Jessica L. Mega, M.D., Cardiovascular Division, Brigham and Women's Hospital, Boston; Hitinder S. Gurm, M.D., director, inpatient services, division of cardiovascular medicine, University of Michigan Cardiovascular Center, Ann Arbor; Richard C. Becker, M.D., director, Cardiovascular Thrombosis Center, Duke University Medical Center, Durham, N.C.; June 17, 2009, The Lancet, online

By Kathleen Doheny
HealthDay Reporter

THURSDAY, June 11 (HealthDay News) -- Eating a diet rich in carbohydrates that boost blood sugar levels -- foods such as cornflakes or white bread -- may hamper the functioning of your blood vessels and raise your risk of developing cardiovascular disease, a new study suggests.

And another study, released Thursday at the Endocrine Society's annual meeting in Washington, D.C., found that people might actually feel fuller -- and might therefore eat less -- if they cut back a bit on carbohydrates in their diet.

In the first study, researchers from Israel's Chaim Sheba Medical Center and elsewhere evaluated 56 healthy but overweight or obese men and women, aged 35 to 60. None had diabetes or a history of hospitalizations for cardiovascular disease.

The researchers fed the men and women on four different mornings, following overnight fasts. They were served either glucose, cornflakes, high-fiber cereal or water, in descending order of glycemic index.

Low-glycemic index foods include oatmeal, most fruits and vegetables, legumes and nuts. White bread, cornflakes and instant potatoes are high-glycemic indexes. The higher the glycemic index, the more that food raises blood sugar levels.

Before and after the meals or the water, the team of researchers measured the functioning of the endothelium, the layer of cells that line the inside of blood vessels. If the endothelial function is poor, it is thought to increase the risk of cardiovascular disease.

The measurement used is called brachial artery flow-mediated dilation (FMD), which measures how well the endothelium is functioning. Researchers also measured the participants' blood sugar levels.

The blood sugar levels before and two hours after the meals were similar, but they were higher at 30 to 90 minutes after the high-glycemic meals.

The FMD was reduced two hours after eating for all groups, but the reduction was more marked after the high-glycemic meals.

The high-glycemic meals, the authors conclude, appeared to impair the endothelial function.

"Based on our study, we do urge consumers to have low-glycemic index carbohydrates instead of high-glycemic carbohydrates for better health and less potential hazards for the vascular endothelial function," said Dr. Michael Shechter, senior cardiologist at The Sackler Faculty of Medicine at Tel Aviv University in Israel.

"The main take-home message is that high-glycemic index carbs are dangerous since they reduce or inhibit endothelial function, which is the 'risk of the risk factors,' leading to atherosclerosis and potentially leading to heart disease," Dr. Michael Shechter said.

Previous research has found that high blood sugar levels after meals is a risk factor for cardiovascular disease, not only in patients with diabetes but in the general population. Declining endothelial function is considered a key variable in the development of hardening of the arteries and heart disease.

The study is published in the June 16 issue of the Journal of the American College of Cardiology.

Another expert called the study "interesting" but added a caveat that more research is needed to confirm the findings. "The cross-over design is a real strength," said Barry Braun, director of the Energy Metabolism Laboratory at the University of Massachusetts, in Amherst. But he said some "dots" still need to be connected.

In the second study, researchers at the University of Alabama at Birmingham investigated whether a small cutback in dietary carbohydrates would actually boost that sense of satiety you get after eating.

Led by professor of nutritional sciences Barbara Gower, the team noted that Americans typically get 55 percent of their daily calories from carbs such as sugars, starches and fiber. This was the "control" diet used in the study. The team had other adult participants go on a moderate carb diet where 43 percent of calories came from carbohydrates. Protein intake (a major influence on satiety) was the same for both diets, but people on the moderate-carb diet took in a bit more fat to make up the difference.

The results: after a month, the 16 participants on the moderate carb diet had lowered blood insulin levels, more stable blood sugar, and a longer duration of a sense of fullness after a meal than did the 14 people on the control diet.

A longer time feeling full might translate into less snacking or eating and perhaps fewer added pounds, the team said. So, "over the long run a sustained modest reduction in carbohydrate intake may help to reduce energy consumption and facilitate weight loss," Gower said in a meeting news release.More information

SOURCES: Barry Braun, Ph.D., associate professor, kinesiology, and director, Energy Metabolism Laboratory, University of Massachusetts, Amherst; Michael Shechter, M.D., senior cardiologist and director, clinical research unit, and senior lecturer, The Sackler Faculty of Medicine, Tel Aviv University, Israel; June 16, 2009, Journal of the American College of Cardiology; June 11, 2009, news release, Endocrine Society

TUESDAY, June 16 (HealthDay News) -- Holes in surgical gloves increase the risk of surgical site infection among patients who aren't given antibiotics before their surgery, Swiss researchers say.

In procedures lasting more than two hours, the rate of glove perforations ranges from 8 percent to 50 percent, according to a study published in the June issue of the Archives of Surgery.

Sterile gloves worn by surgical staff can be perforated by needles, bone fragments and sharp surgical instruments, and the resulting holes enable skin-borne pathogens to travel from the hands of surgical staff into patients.

In the study, Dr. Heidi Misteli and colleagues analyzed 4,417 surgical procedures performed at University Hospital Basel between 2000 and 2001, and found that sterile glove perforations occurred in 677 of the surgeries. Antibiotic therapy given before surgery to prevent infection was used in 3,233 of the surgeries, including 605 of the surgeries involving perforated gloves.

Overall, there were 188 surgical site infections (4.5 percent of surgeries), with 7.5 percent of infections occurring in procedures performed with perforated gloves and 3.9 percent occurring in procedures where gloves remained intact, the researchers found.

In surgeries where antibiotics were used, glove perforation wasn't associated with surgical site infection. Among patients who didn't receive antibiotics, surgical site infection rates were 12.7 percent when glove perforation occurred and 2.9 percent when there was no glove perforation.

"The present results support an extended indication of surgical antimicrobial prophylaxis [antibiotics] to all clean procedures in the absence of strict precautions taken to prevent glove perforation," Dr. Heidi Misteli and colleagues concluded. "The advantages of this surgical site infection prevention strategy, however, must be balanced against the costs and adverse effects of the prophylactic antimicrobials, such as drug reactions or increased bacterial resistance."

The study authors noted that procedures to reduce the risk of glove perforation -- such as double gloving and replacing gloves more frequently --are effective and safe and should be encouraged.More information

-- Robert Preidt

SOURCE: JAMA/Archives journals, news release, June 15, 200

By Steven Reinberg: HealthDay Reporter

THURSDAY, June 4 (HealthDay News) --Older people taking common over-the-counter drugs for pain, cold symptoms or help with sleep may increase their risk for cognitive impairment, including delirium, University of Indiana researchers report.

These drugs include Benadryl, Dramamine, Excedrin PM, Nytol, Sominex, Tylenol PM and Unisom.

All of these over-the-counter (OTC) drugs contain benadryl (diphenhydramine), a molecule that blocks the neurotransmitter acetylcholine. Acetylcholine is essential for normal functioning of the central and peripheral nervous systems, the researchers explained.

"Before taking any medication prescribed by your doctor or an OTC medication, make sure there is no negative impact of this medication on your brain," said lead researcher Dr. Malaz Boustani.

His group analyzed data from 27 prior studies on the relationship between anticholinergic effects and brain function, as well as looking into anecdotal data. The team found a consistent link between anticholinergic effects and cognitive impairment in older adults.

"Any OTC medication with the term 'PM' will indicate the presence of benadryl, which is bad for the brain," Dr. Malaz Boustani concluded.

He noted that the effects of benadryl can add up, so the more medications you take that contain benadryl the worse it may be for cognition. "There is a relationship with the number of medications and the burden on your aging brain," the researcher said.

People aged 65 and older who take these medications also run the risk of developing delirium, Boustani said. Delirium is a decline in attention-focus, perception and cognition, or "acute brain failure," as Boustani calls it. Delirium typically increases the odds of dying or being institutionalized, he said.

 In addition, taking these medications for 90 days or more may triple your risk of developing Alzheimer's disease, Boustani said.

Given the risks, older adults should look for drugs that don't contain benadryl, he said.

"A lot of these medications are not recognized for these side effects," he contended. "It's time for the FDA to start taking this negative impact of these medications on the aging brain seriously."

The report is published in the May online issue of the Journal of Clinical Interventions in Aging.

According to Boustani, researchers in brain pharmacoepidemiology at Indiana University's Center for Aging Research is conducting a study of 4,000 older adults to see if the long-term use of medications with anticholinergic effects is associated with the development of severe cognitive impairment, such as Alzheimer's disease.

Dr. Clinton Wright, an associate professor of neurology at the Miller School of Medicine at the University of Miami, agreed that more study is needed to assess the effects of these drugs on the brain.

"These findings don't surprise me at all," Wright said. "People tend not to think of their OTC medications as medication, but any medication that has anticholinergic effects can affect people's cognition."

Wright believes the drugs should carry a warning of this potential side effect.

Deborah G. Bolding, a spokeswoman for GlaxoSmithKline, the maker of Sominex, defended the product and said it complies with all current FDA regulations. However, she would not comment specifically on whether diphenhydramine is associated with an increased risk of delirium in older adults.

"Sominex is a mild sleep aid designed to help individuals through periods of nervous tension or stress, which are accompanied by sleeplessness. It has been proven safe and effective in medical tests when taken as directed, and has been safely used by millions of satisfied customers," Bolding said.

"For all formulations, Sominex's active ingredient is diphenhydramine hydrochloride. This is marketed under a final FDA monograph as an over-the-counter sleep aid," she added.More information

SOURCES: Malaz Boustani, M.D., associate professor, medicine, Indiana University School of Medicine, Indianapolis; Clinton Wright, M.D., associate professor, neurology, Miller School of Medicine, University of Miami; Deborah G. Bolding, spokeswoman, GlaxoSmithKline; May 2009, Journal of Clinical Interventions in Aging, online

By Amanda Gardner: HealthDay Reporter

WEDNESDAY, June 10 (HealthDay News) -- More potentially harmful health effects have been discovered for the chemical bisphenol A, found in clear plastic bottles and other everyday items, according to several new animal studies.

Not only are humans probably being exposed to generally unsafe levels of BPA, as the chemical is commonly called, but it could be causing arrhythmias, or irregular heartbeats, research shows. That could be especially problematic for women, who may be at higher risk for this type of cardiac threat.

In addition, other researchers say that they have found the mechanism by which BPA, a synthetic hormone with estrogen-like properties, might affect later fertility of babies whose mothers were exposed to the chemical.

These findings are being reported this week at the Endocrine Society's annual meeting, in Washington, D.C.

BPA, a chemical used to harden plastics, is in myriad items, including CDs, sunglasses and dental sealants. It is also in the lining of metal cans and bottle tops. Some studies have linked it to cancer, diabetes, heart disease and developmental problems in children. Health advocates say exposure to the chemical could present a particular problem to developing fetuses.

The U.S. Food and Drug Administration agreed in early June to reconsider its position that BPA is safe at levels found in baby bottles and other common products.

Researchers for one of the studies to be presented this week concluded that estrogen and BPA cause heartbeat irregularities in heart cells isolated from rats and mice.

"Basically, it's very clear that BPA is acting like estrogen," said study co-author Scott Belcher, an associate professor of pharmacology at the University of Cincinnati. "If we give estrogen at physiological concentrations, then add BPA, it's actually a synergistic effect. It's not like adding the two together. It's worse."

Women are more likely to die after a heart attack than men, and Belcher suspects an increased rate of arrhythmia might bear some of the responsibility for that trend.

His team is currently collecting human heart cells from transplant patients to try to replicate the findings.

In another study, researchers report on the mechanism by which BPA affects fertility in the offspring of rodents.

"The genes that are necessary for normal pregnancy are altered," explained study author Dr. Hugh Taylor, director of the division of reproductive endocrinology at Yale University School of Medicine. "It changes the DNA code and the ability of DNA to express these genes."

"A little transient exposure during a brief time period in pregnancy could permanently alter the DNA of the uterus," Taylor added.

For pregnant women, the message is "just try avoiding drinking out of hard water bottles and eating out of cans and perhaps not getting expensive dental work with sealants," Taylor said. "There's nothing wrong with eating fresh vegetables."

In a third study, researchers warned that people may be getting higher-than-recommended exposure to BPA from both known and unknown sources, a conclusion they drew from research involving monkeys. The researchers, from the University of Missouri, had compared the blood level of BPA in monkeys given high doses of the chemical with average levels found in people in the United States and other developed countries.

More than 8 billion pounds of BPA are used in the manufacturing of products each year, they said.

Chemical industry representatives, however, disagree that the findings represent any real threat to human health.

"It is disappointing to see that researchers continue to inject animals with bisphenol A since studies of this type have recently been acknowledged by the National Institute of Environmental Health Sciences to have limited impact on our ability to assess human health effects," said Steve Hentges, executive director of the Polycarbonate/BPA Global Group at the American Chemistry Council.

"Most notably though, a study on rhesus monkeys appears to confirm that bisphenol A is efficiently converted after oral exposure to biologically inactive metabolites, which are then rapidly eliminated from the body without bioaccumulation," Hentges added. "This data supports the conclusions of many government bodies worldwide that bisphenol A is not a significant health concern."More information

SOURCES: Hugh Taylor, M.D., associate professor, and director, division of reproductive endocrinology, Yale University School of Medicine, New Haven, Conn.; Scott Belcher, Ph.D., associate professor, pharmacology, University of Cincinnati; Steven G. Hentges, Ph.D., executive director, Polycarbonate/BPA Global Group, American Chemistry Council, Arlington, Va.; June 10, 2009, presentations, Endocrine Society annual meeting, Washington, D.C.

By Steven Reinberg: HealthDay Reporter

THURSDAY, June 11 (HealthDay News) -- The World Health Organization was set on Thursday to declare the first influenza pandemic since 1968, due to the H1N1 virus' rapid spread in North America, Australia, South America, Europe and regions beyond, health officials said.

On Thursday, WHO convened an emergency teleconference, scheduled to begin at 6 a.m. EDT, to discuss the situation with leading flu experts, the Associated Press reported. Health officials from Indonesia, Scotland and Thailand have said that WHO would likely declare a swine flu pandemic following that conference.

A surge in cases of H1N1 swine flu in Australia may have tipped the balance and made a pandemic declaration likely, agency officials said Tuesday.

Cases in Australia rose by more than 1,000 on Monday, with most occurring in the southern state of Victoria. Rapid spread of the virus in a region beyond North America has been considered a key factor in labeling the outbreak a pandemic.

On Thursday, Indonesia's health minister, Siti Fadilah Supari, said WHO had notified her that "today will be declared to be phase 6," the pandemic level of the outbreak.

"We are getting really very close to knowing that we are in a pandemic situation," WHO influenza chief Keiji Fukuda said in Geneva on Tuesday.

He said the agency was concerned about the possible "adverse effects" of moving the alert from its current status of phase 5 to the highest level, phase 6, indicating a full pandemic, the AP reported. Fukuda cited concerns over possible panic among the public or inappropriate steps taken by governments.

However, "on the surface of it, I think we are in phase 6," Margaret Chan, the WHO's director-general, had also noted on Tuesday. According to Chan, it is crucial to verify that H1N1 has become established beyond North America before a pandemic is declared. "Once I get indisputable evidence, I will make the announcement," she said.

On Wednesday, Chan held a teleconference with representatives from eight countries with large swine flu outbreaks to determine if a pandemic should be declared.

According to the latest WHO data, there are now 27,737 reported cases of swine flu infection across 74 countries, including 141 deaths. That includes 13,217 cases and 27 deaths reported as of last Friday in the United States by officials at the U.S. Centers for Disease Control and Prevention.

While the vast majority of infections and deaths have occurred in Mexico (the source of the outbreak) and the United States, person-to-person transmission in now being reported in Australia and Chile, as well as Great Britain, Spain and Japan, according to published reports.

But Fukuda also expressed concern Tuesday about reports of unusually large numbers of severe cases among Canada's Inuit population, according to AP.

The vast majority of swine flu cases globally have remained mild, but some of the deaths have occurred in otherwise healthy people, the WHO noted. "Approximately half the people who have died from this H1N1 infection have previously been healthy people," Fukuda said. He called that "one of the observations which has given us the most concern."

Since the outbreak started in April, health officials in the United States have also said that infections have been mild for the most part, and most patients recover fairly quickly. Testing has found that the H1N1 virus remains susceptible to two common antiviral drugs, Tamiflu and Relenza.

During the next few months, CDC scientists will be looking to see if the swine flu virus mutates or becomes resistant to antiviral medications, or is more easily spread among people.

U.S. health officials have said there's no way to tell now if the H1N1 virus will be more virulent when -- and if -- it returns to the Northern Hemisphere with the approach of winter.

A vaccine for the swine flu virus could be ready by October, if research and testing proceed on pace this summer. Candidate viruses have been shipped to vaccine manufacturers, agency officials said.

It's still not clear whether such a vaccine is needed. Any decision to move forward would be based on several factors, including the severity and spread of the virus and whether there's a safe and effective vaccine, the CDC has said.More information

SOURCES: Associated Press; U.S. Centers for Disease Control and Prevention

By Ed Edelson: HealthDay Reporter

WEDNESDAY, June 10 (HealthDay News) -- Men with moderately advanced prostate cancer who get hormone-blocking drugs after radiation therapy do better when the drug treatment is continued for two or more years after an initial six-month regimen, a European study has found.

The results pretty much mirror those of a similar American trial reported in May, said Dr. Eric M. Horwitz, acting chairman of radiation oncology at Fox Chase Cancer Center in Philadelphia, who led the group that did the U.S. study.

"We have long believed that longer-term hormone therapy is the standard of care," Horwitz said. "These studies support that belief."

The results apply to men whose cancer shows signs of growth but has not spread beyond the prostate gland -- perhaps a quarter of all cases of prostate cancer, Horwitz said.

Earlier studies in the United States and Europe established the value of radiation therapy followed by six months of hormone-blocking treatment in such cases, he said. The new studies were designed to determine whether continuation of drug therapy that blocks the cancer-promoting activity of the male hormone testosterone could improve those results.

Though the studies differed in size and length, their results were similar in most respects.

The European trial, reported in the New England Journal of Medicine, included 970 men who were assigned to radiation therapy followed by either six months or three years of hormone-suppressing treatment. The five-year death rate of men in the longer-treatment group was 15.2 percent, compared with 19 percent for those in the shorter-term treatment group.

The U.S. study, published in the Journal of Clinical Oncology, included 1,554 men who were followed for 10 years. The study found no significant difference in overall survival -- 51.6 percent for the short-term group, given four months of treatment, and 53.9 percent for the long-term group, treated for two years.

But it did find a difference among men who were alive and cancer-free after 10 years. The disease-free survival rate for the short-term group was 13.2 percent, compared with 22.5 percent for those treated longer.

Other measures, such as the spread of cancer to other parts of the body and greater growth of the malignancy within the prostate gland, were consistently better for men in the U.S. study who'd had the longer-term therapy.

Horwitz said that differences between the American and European results were not unexpected. Similar differences had been found in the studies that established the value of the radiation-plus-hormone therapy, he said. One possible explanation, he said, is that prostate cancers tend to be diagnosed at an earlier stage in the United States because of extensive screening programs.

Both studies reported the expected side effects of hormone-blocking therapy, including hot flashes, weight gain, osteoporosis and loss of sexual function.

"Some men get them and some do not," Horwitz said. "Over the last few years, there has been a lot of attention paid to these side effects, in the medical literature and in public awareness, and there has been more reluctance to use this therapy. These studies clearly identify a group of men who benefit from this therapy."

But Dr. Peter C. Albertsen, chairman of urology at the University of Connecticut Health Center, said that it's those side effects that should limit the use of longer hormone-blocking therapy to a specific group of men with prostate cancer -- those with "disease that is clinically evident on palpation [by touching] but with no evidence that it has spread outside the prostate," Albertsen wrote in an accompanying editorial in the journal.

He agreed that earlier forms of the cancer are more often detected in the United States than in Europe because of extensive screening programs. The side effects that balance the benefits of hormone-blocking therapy rule against extended therapy for those men, Albertsen said.

"For men with localized disease that is screening-detected, the equation is quite different," he said.More information

SOURCES: Eric M. Horwitz, M.D., chairman, radiation oncology, Fox Chase Cancer Center, Philadelphia; Peter C. Albertsen, M.D., professor, surgery, and chairman, urology, University of Connecticut Health Center, Farmington, Conn.; June 11, 2009, New England Journal of Medicine

By Ed Edelson: HealthDay Reporter

SUNDAY, June 7 (HealthDay News) -- Drugs should be the first line of treatment for diabetics who are also battling heart disease, a new study finds.

Only if further steps are deemed necessary should invasive interventions such as angioplasty or bypass surgery be added, the experts said.

The issue is crucial to millions of Americans, since diabetes is a major risk factor for coronary artery disease and stroke.

But the findings of the study -- to be presented Sunday at the American Diabetes Association annual meeting in New Orleans and released simultaneously online in the New England Journal of Medicine -- may not end the argument over which approach, medicine or surgery, is the best frontline treatment to ward off heart woes.

The trial enlisted almost 2,400 people with type 2 diabetes, the kind that generally develops in adulthood. These patients also had coronary artery blockages. Outcomes for the entire group were tracked for five years after treatment.

All got intensive drug therapy, either with insulin or with drugs such as metformin that increase the body's sensitivity to insulin, while some also had procedures to improve blood flow.

At five years, 87.8 percent of those getting drug therapy alone were still alive, compared to 88.3 percent of those getting drug therapy plus a surgical procedure -- not a significant difference. The incidence of major cardiovascular events such as heart attacks and stroke was also similar, at 75.9 percent in the medical treatment group and 77.2 percent in the drug-plus-procedure group. In the drug-only group, those getting insulin sensitization treatment did slightly better than those who got insulin therapy.

Reacting to the findings, the Society for Cardiovascular Angiography and Interventions issued a statement saying that the trial still "does not answer" the question of whether all diabetic patients with multi-vessel coronary artery disease might be better treated with optimal drug therapy plus angioplasty or bypass.

Results from another ongoing trial "may shed more light" on the issue, the statement added.

What the study did show was that for people with diabetes and stable coronary artery disease, "a strategy of prompt revascularization [surgical opening of arteries] did not benefit patients relative to medical therapy alone," said trial leader Maria Mori Brooks, associate professor of epidemiology at the University of Pittsburgh Graduate School of Public Health.

Increasing severity of disease seemed to matter, however. "For patients who had more severe heart disease, there was a benefit from bypass surgery vs. medical therapy alone," she said.

That benefit was not seen in survival rates, which did not differ much in groups given various treatments. The real gap in outcomes came in the rate at which patients suffered major cardiovascular events such as heart attack and stroke. Those were significantly lower when bypass surgery was added to drug therapy, the researchers found.

The results confirm those of a similar trial reported two years ago, noted Dr. William Boden, a professor of medicine and preventive medicine at the State University of New York, and co-author of an editorial accompanying the journal report. In particular, the new study showed that if a procedure is needed to restore coronary blood flow, "bypass surgery is more likely than angioplasty to reduce the incidence of recurrent heart attacks. No other study to my knowledge has shown that bypass surgery reduces the incidence of myocardial infarction [heart attack]," he said.

Yet dissent arose even on that point.

Dr. Kirk Garratt, director of interventional cardiovascular research at Lenox Hill Hospital in New York City, said that the new trial did not directly compare bypass surgery with angioplasty. Outcomes differed because physicians were free to choose between the two methods of restoring blood flow, and they were more likely to choose bypass surgery for more complex cases, he said.

Brooks agreed that the intent of the study was not to compare bypass and angioplasty. What the study showed was "no more than a 3 percent difference in benefit in terms of one therapy or another," she said.

The results of the new trial are a testament to the ability of new medicines to help people with diabetes avoid heart problems, Boden said.

"We have very powerful medications today," he said. "These are disease-modifying therapies that can alter the course of the disease. We in this country have been enamored of the benefits of angioplasty and stents. It is reassuring to me, and hopefully other physicians, to see what can be accomplished by optimal medical therapy."More information


SOURCES: Maria Mori Brooks, Ph.D, associate professor, epidemiology, University of Pittsburgh Graduate School of Public Health; Kirk Garratt, M.D., director, interventional cardiovascular research, Lenox Hill Hospital, New York City; William Boden, M.D., professor, medicine and preventive medicine, State University of New York at Buffalo; June 7, 2009, New England Journal of Medicine online; June 7, 2009, presentation, American Diabetes Association annual meeting, New Orleans

By E.J. Mundell: HealthDay Reporter

MONDAY, June 8 (HealthDay News) -- An experimental diabetes drug called liraglutide appears to outperform exenatide (Byetta), the only currently approved drug in its class, a study funded by liraglutide's maker, Novo Nordisk, shows.

Liraglutide is a laboratory-made version of glucagon-like peptide-1 (GLP-1), a hormone produced by the body that stimulates insulin production. Several members of the GLP-1 family are in clinical trials.

In the new phase III trial -- usually the last kind done before marketing approval is sought -- injecting liraglutide once daily showed greater benefits in terms of blood sugar control and appeared to be easier on patients than Byetta, which is injected twice a day, according to a report published online June 8 in The Lancet to coincide with its presentation at the American Diabetes Association's annual meeting in New Orleans.

Patients taking liraglutide also lost more weight during the 26-week trial than those taking Byetta, the researchers report. Byetta was approved by the U.S. Food and Drug Administration in 2005.

"The results suggest that liraglutide might be a treatment option for type 2 diabetes, especially when weight loss and risk of hypoglycemia are major considerations," wrote a team led by Dr. John Buse, of the University of North Carolina School of Medicine.

In the study, 464 adult patients with inadequately controlled type 2 diabetes were randomized to receive either liraglutide at 1.8 milligrams once daily or Byetta at 10 micrograms two times per day. All of the participants were also taking the maximum tolerated doses of either the standard diabetes drug metformin, sulphonylurea or both.

Patients on liraglutide showed better glucose control based on their blood HbA1C measurements, which track blood sugar fluctuations over time, the team reported. The experimental drug was also more than twice as good as Byetta at reducing mean fasting blood glucose levels. On the other hand, Byetta performed better than liraglutide at reducing blood sugar immediately after meals, suggesting that liraglutide exerts its effects prior to food intake, or during fasting, according to the authors.

Patients on liraglutide lost an average of about seven pounds during the trial, compared to about 6.4 pounds for those taking Byetta, the team said.

In a journal editorial, Drs. Christophe De Block and Luc Van Gaal, of the University of Antwerp in the Netherlands, wrote that the trial "shows that liraglutide provides greater improvements in glycemic control and is better tolerated than exenatide."

The study follows a similar trial, published in The Lancet last September, which found liraglutide performed better than a now-standard medication from a different class, glimepiride (Amaryl). That trial was also sponsored by Novo Nordisk.

Like the other GLP-1 versions, liraglutide has all the advantages of the natural molecule, with longer-lasting activity, said Dr. Sten Madsbad, a professor of endocrinology at the University of Copenhagen in Denmark, who wrote an editorial that accompanied the September study.

"First, it stimulates insulin production," Madsbad explained. "Then it also promotes glucagon release from the pancreas. It also changes appetite, and therefore you eat less." Glucagon is a hormone that helps manage blood sugar levels.

"We want more medications that have this type of profile," Dr. Alan Garber, a professor of medicine, biochemistry and cell and molecular biology at Baylor College of Medicine, in Houston, and lead author of the liraglutide/glimepiride trial, said at the time of its release.

"It is very well-tolerated, has few side effects and can lead to weight loss," Garber said. "Most diabetes medications now produce weight gain, and that is very discouraging to our patients."

In related news, also published simultaneously in The Lancet and at the diabetes association meeting, researchers reported data from a phase II trial for another experimental diabetes drug, aleglitazar. That trial assessed the safety and effectiveness of the drug, one of a class of medications called PPAR co-agonists that affect both blood sugar control and fat.

In the 16-week trial, 332 patients with type 2 diabetes received either once-daily doses of aleglitazar (at varying doses), the diabetes drug pioglitazone (Actos), or a placebo.

At lower doses, aleglitazar appeared safe and effective, with less incidence of heart failure or edema than either Actos or placebo; it produced less weight gain than Actos when given at the 150-microgram dose.

"The favorable balance in the safety and efficacy profile of aleglitazar represents encouraging short-term clinical data for this agent, and provides good evidence to enter phase III investigation," wrote a team led by Dr. Robert R. Henry of the University of California, San Diego.

The study was funded by aleglitazar's maker, F. Hoffmann-La Roche AG.More information



SOURCES: Alan Garber, M.D., Ph.D., professor, medicine, biochemistry and cell and molecular biology, Baylor College of Medicine, Houston; Sten Madsbad, M.D., professor, endocrinology, University of Copenhagen, Denmark; June 8, 2009, The Lancet, online

THURSDAY, June 4 (HealthDay News) --Sedatives greatly increase the risk of suicide in the elderly, Swedish researchers say.

In their study, hypnotic medication also was linked with a greater likelihood of suicides in older people. "Sedative treatment was associated with an almost 14-fold increase of suicide risk in the crude analysis and remained an independent risk factor for suicide even after adjustment for the presence of mental disorders," wrote Anders Carlsten, of Gothenburg University. "Having a current prescription for a hypnotic was associated with a fourfold increase in suicide risk in the adjusted model."

The drugs may increase suicide risk in the elderly by triggering aggressive or impulsive behavior, or by providing the means to take an overdose, the researchers said. It's also possible that sedatives may merely be markers for other factors related to suicide, such as sleep disturbance, lack of a social network, interpersonal problems, alcohol abuse and physical disability.

"Persons with these problems might be more likely to seek health care and perhaps more likely to receive prescriptions for psychotropic drugs. However, given the extremely high prescription rates for these drugs, a careful evaluation of the suicide risk should always precede prescribing a sedative or hypnotic to an elderly individual," Carlsten said.

The study appears in the current issue of BMC Geriatrics.More information

-- Robert Preidt

SOURCE: BioMed Central, news release, June 3, 2009

By Ed Edelson: HealthDay Reporter

MONDAY, June 1 (HealthDay News) -- About half the people who have a major stroke soon after a less serious brain event, such as a transient ischemic attack or "mini-stroke," do so within 24 hours of the minor event, a new study finds.

The message here for people who have a TIA is to "seek medical attention immediately, particularly if you have either weakness or speech disturbance that lasts more than 10 minutes," said the study's senior author, Dr. Peter M. Rothwell, a professor of clinical neurology at the University of Oxford in England.

"Don't wait until the next day -- it may be too late," he said.

Reporting in the June 2 issue of Neurology, Rothwell and his colleagues looked at the medical records of 1,247 people who had a TIA, which is a momentary blockage of blood flow in a brain artery.

Of those, 35 went on to have recurrent strokes within the next 24 hours. In that group, 1.2 percent of the second strokes occurred within six hours, 2.1 percent within 12 hours and 5.1 percent within 24 hours, the team found.

"That about half of all the recurrent strokes in the seven days after a TIA occur in the first 24 hours highlights the need for emergency assessment," the researchers wrote.

That assessment should look at the well-established "ABCD2" stroke risk factors, Rothwell said. These include:

"Patients should be investigated and treated as an emergency, certainly those with a high ABCD2 score," Rothwell said.

While TIAs and minor strokes are well known to be warning signs of major trouble ahead, "no study has shown how high the risk is in the first few hours -- i.e., that TIA and minor stroke is a true neurological emergency," he said.

Immediate action can lessen the risk, Rothwell said. "We published a paper in Lancet in November 2007 looking at the benefits of emergency treatment versus standard treatment," he said. "We showed that the risk of major stroke can be reduced by up to 80 percent simply by initiating standard treatment as an emergency measure -- aspirin plus or minus clopidogrel [Plavix], statin therapy, blood pressure reduction."

Clopidogrel and aspirin are both aimed at the clots that can cause a stroke by blocking a brain artery. Statins are drugs such as Crestor, Lipitor and Zocor that lower blood cholesterol levels.

Brain images can illustrate why risk of a recurrence might be highest in the hours after a TIA or minor stroke, Rothwell pointed out. "When we do perfusion [blood flow] brain scans in these patients, we do sometimes find that they have occluded an artery in the brain with a blood clot but the brain is surviving on indirect blood flow from the other vessels," he said. "After a few hours, this indirect blood flow sometimes fails and the affected brain area then dies -- they have a stroke."

Dr. Howard S. Kirshner, vice chairman of neurology and director of the Stroke Center at Vanderbilt University Medical Center and a spokesman for the American Academy of Neurology, agreed that "all of this supports the idea that TIA is a medical emergency, that patients who experience a TIA need to seek medical attention right away."

"For the emergency department, TIA patients should not be sent right home but should be kept for observation and tested,"Dr. Howard S. Kirshner said. "They can be sent home if the tests are negative and they already are started on a secondary stroke prevention regimen."

Dr. Daniel Laskowitz, an associate professor in neurology at Duke University, said that the study is important because it marks a new emphasis on prevention in stroke medicine.

Once a stroke occurs, treatment options are limited, so where the effort needs to go is stroke prevention, Laskowitz said. And this adds to a body of literature that if you have a TIA, you are at very high risk of a stroke."

"A TIA should send a strong warning. It is not something that needs to be seen next week," Laskowitz stressed. "There are clear interventions that we can perform to prevent a stroke. So this has a direct practical application to how we manage stroke.More information

SOURCES: Peter M. Rothwell, M.D., Ph.D., professor, clinical neurology, University of Oxford, England; Howard S. Kirshner, M.D., vice chairman, neurology, and director, Stroke Center, Vanderbilt University Medical Center, Nashville, Tenn.; Daniel Laskowitz, M.D., associate professor, neurology, Duke University Medical Center, Durham, N.C.; June 2, 2009, Neurology

By Ed Edelson: HealthDay Reporter

THURSDAY, May 28 (HealthDay News) -- A new analysis showing that a potent clot-dissolving drug can safely be used to treat strokes four-and-a-half hours after symptoms begin has prompted a change in a current recommendation, which set a three-hour deadline for the medication's use.

The review of 1,622 cases of people treated with tissue plasminogen activator (tPA) in four separate studies finds that the benefit in keeping brain cells alive outweighs the risk of brain-damaging bleeding when the drug is given up to 4.5 hours after first symptoms, according to a report in the May 28 online issue of Stroke. The most convincing results came from the latest study, in which 821 people were treated later than is currently recommended.

"By pooling data from four prior clinical trials in which patients were treated with tPA between three and four-and-a-half hours, we were able to demonstrate that treatment with tPA is beneficial even if it is started between three and four-and-a-half hours of symptom onset," said study author Dr. Maarten Lansberg, an assistant professor of neurology and neurological sciences at Stanford University.

An advisory committee of the American Stroke Association/American Heart Association (ASA/AHA) promptly issued a recommendation that the window for tPA therapy be opened that much wider; that advisory appears in the same issue of Stroke.

"The advisory updates the current guidelines to recommend treatment in select patients in the three- to four-and-a-half hour window, but urges confirmation of the trial's results with further analyses," according to a statement issued by the ASA/AHA.

"In practical terms, wide adoption of the recommendation would mean that 2 percent to 3 percent more people who suffer strokes caused by blockage of a brain artery would receive tPA therapy," said Dr. Jeffrey L. Saver, a professor of neurology at the University of California, Los Angeles, and a member of the advisory committee.

That might not seem a great leap forward, but Saver noted that "right now, at well-performing hospitals, 5 to 10 percent of stroke patients are treated in under three hours."

"That disappointing number is due primarily to the widespread failure of people to know the symptoms of a stroke and take immediate action when they are seen," he said.

"This re-emphasizes that what we need to highlight for the public is the importance of getting aid as soon as symptoms begin," **Dr. Jeffrey L. Saver said. "Therapy with tPA is most effective when given in the first hour. One hour is better than two, two is better than three, three is better than four. Should there be weakness on one side of the body, trouble speaking, trouble with vision, if any of those signs occur, call 911 at once."**

The chief concern with tPA is that it might cause excess bleeding that damages the brain, Saver said. But data cited in the new study show that "for every 100 patients treated with tPA between three and four-and-a-half hours after symptoms, 16 will have a better outcome, and two or three will have a worse outcome," he said. "The treatment has risks, but we help six patients for every one we harm."

The benefit is seen in the 80 percent to 85 percent of strokes caused by an artery blockage. Treatment with tPA is not recommended for the 10 percent to 15 percent of strokes that are caused by a burst brain vessel.

The U.S. Food and Drug Administration set a three-hour limit on use of tPA in strokes when it was approved 13 years ago, Saver noted. "Now we have the first expansion of guidelines for giving a clot-dissolving drug, so it is an important advance in stroke care," he said.

But tPA should not be used beyond the three-hour limit in a number of cases, the advisory committee said -- people aged 80 and older, those having a severe stroke, those with a history of stroke and diabetes and those taking clot-preventing drugs such as Coumadin.

For anyone who has a stroke, "Time lost is brain lost," Dr. Jeffrey L. Saver said. "Every minute, 2 million neurons die. What we want to see is door to needle time of 60 minutes."More information

SOURCES: Maarten Lansberg, M.D., assistant professor, neurology and neurological sciences, Stanford University, Palo Alto, Calif.; Jeffrey L. Saver, professor, neurology, University of California, Los Angeles; May 28, 2009, Stroke

By Steven Reinberg: HealthDay Reporter

THURSDAY, May 28 (HealthDay News) -- One month after mandating stricter warning labels about the risk of liver damage from the painkiller acetaminophen, U.S. regulators are contemplating even tougher standards.

Advisers to the U.S. Food and Drug Administration will meet late next month to review a new agency report that calls for stronger warnings, better consumer education, and limits on doses for both prescription acetaminophen and over-the-counter acetaminophen, best known as Tylenol.

Part of the problem, according to the FDA report, released Wednesday, is that severe liver damage can result from a lack of consumer awareness that acetaminophen can cause such injury. Also, many people may take more than the recommended dose of over-the-counter pain relievers in the mistaken belief that taking more will be more effective against pain without posing health risks. And consumers may not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur," the report said.

The report also calls for limiting the maximum adult daily dose to no more than 3,250 milligrams, but with a lower daily maximum for patients consuming three or more alcoholic drinks every day while using acetaminophen products. It also recommends limiting the tablet strength for immediate-release formulations to a maximum of 325 milligrams, and the single adult dose to a maximum of 650 milligrams.

The recommendations also include:

On April 28, the FDA said many over-the-counter painkillers and fever reducers will now have to carry new warnings on the potential danger of liver damage and stomach bleeding.

Manufacturers will have to include these warnings on all their over-the-counter products containing acetaminophen, and on all non-steroidal anti-inflammatory drugs (NSAIDs) drugs, the agency said.

NSAIDs include popular medicines such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve) and Excedrin.

The purpose of the new labeling is to raise awareness of potential liver damage from acetaminophen and the potential for stomach bleeding from NSAIDs, the FDA said.More information



SOURCE: May 28, 2009, news release, U.S. Food and Drug Administration; April 28, 2009, teleconference with Matthew Holman, Ph.D., deputy director, Division of Nonprescription Regulation Development, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

THURSDAY, May 28 (HealthDay News) -- Stimulant chewing gum can be dangerous if used excessively by children and teens, warn doctors who wrote a case report about a teenage boy who was hospitalized after chewing a large amount of the caffeine-containing gum.

The case involved a 13-year-old Italian boy who was taken to hospital after his family noted he was agitated and aggressive, which wasn't typical for him. The boy also had abdominal discomfort, increased and painful urination, and prickling sensations in his legs.

Emergency department doctors found that the boy had a rapid heartbeat (147 beats per minute), rapid breathing (25 breaths per minute) and elevated blood pressure (145/90 mm Hg). His blood tests were normal and he tested negative for illicit drugs.

The boy spent the night in hospital without treatment and was discharged the following morning, with the only unusual symptom being a slow heartbeat (40 bpm). The doctors later learned that the boy had consumed two packets of stimulant chewing gum within a four-hour period. The two packs of gum contained a total of 320 milligrams of caffeine, slightly more than three regular cups of coffee.

The boy met the criteria for diagnosis of caffeine intoxication, said the doctors.

"Our patient…presumably had high caffeine sensitivity in view of his low habitual caffeine intake, so 320 mg was a substantial amount of caffeine," wrote Francesco Natale, of the Second University of Naples and Monaldi Hospital in Naples, and colleagues.

"It was unlikely that…other ingredients of the chewing gum played a part in this case, because their doses were low or they would induce different signs and symptoms from those found in our patient. The use of stimulant chewing gum should be considered in cases of caffeine intoxication. The risk of intoxication is high in children and teenagers in view of general caffeine-naivety, and the unrestricted sale of these substances," the authors concluded.

The case study appears in the May 30 issue of The Lancet.More information

-- Robert Preidt

SOURCE: The Lancet, news release, May 28, 2009

By Amanda Gardner: HealthDay Reporter

SUNDAY, May 31 (HealthDay News) -- Common antidepressants that many breast cancer survivors use to dampen the hot flashes caused by taking tamoxifen may actually boost the odds of the disease's return, new research warns.

The finding was presented this weekend at the American Society of Clinical Oncology's annual meeting, in Orlando, Fla.

But to muddy the waters further, a second study found that the antidepressants did not impair tamoxifen's cancer-fighting powers.

Nevertheless, authors from both reports are recommending that women who have had breast cancer explore other ways to treat hot flashes.

Outside experts agreed.

"Women should talk to their medical oncologist about what antidepressant they're and what hormone therapy they're on, and make sure they're not one of the ones we're worried about," said Dr. Kelly Marcom, a breast oncologist with the Duke Comprehensive Cancer Center and director of the Duke Hereditary Cancer Clinic, in Durham, N.C.

Many breast cancer survivors take the drug tamoxifen to reduce their odds for recurrence. But tamoxifen often causes hot flashes, a side effect that can be controlled with selective serotonin reuptake inhibitor (SSRI) antidepressants such as paroxetine (Paxil) or fluoxetine (Prozac). Besides working on the neurotransmitter serotonin, these drugs inhibit an enzyme called 2D6, necessary to convert tamoxifen into its main active metabolite, endoxifen.

Women who have a gene mutation preventing the formation of 2D6 do not reap the same benefits from tamoxifen as women without the mutation, the researchers noted. Moreover, drugs that inhibit the formation of 2D6 may result in lower levels of endoxifen, although the clinical implications of that remain unclear.

The U.S. Food and Drug Administration is still weighing whether or not to add a caution about the gene variation to the tamoxifen label.

In one of the studies, Medco, a U.S. pharmacy benefits management company, reviewed the medical records of 10.7 million members of a health plan. That analysis turned up 945 women taking tamoxifen and 353 taking tamoxifen plus an SSRI/2D6 inhibitor, most commonly Prozac and Paxil.

Both groups of women, whose average age was in the early 50s, had followed similar treatment courses.

Women taking both drugs had a 13.9 percent chance of their breast cancer returning over two years, vs. just 7.5 percent of those receiving tamoxifen alone; that translates into an almost twofold increase in risk.

The second study, conducted by researchers at Leiden University Medical Center in the Netherlands, collected information on almost 2,000 breast cancer patients using tamoxifen, 215 of whom had used an SSRI/2D6 inhibitor at some point during their tamoxifen treatment.

That study found no increased risk of a breast recurrence in women taking both drugs. However, the authors pointed out, the number of women taking both drugs was small -- good enough reason for women and doctors to search for other options to combat hot flashes.

The Medco findings should serve as a warning but not a confirmation of any real danger to patients, one expert said.

"It's a study that is very difficult to interpret because it's really not complete enough information," said Dr. Claudine Isaacs, director of the clinical breast cancer program at Georgetown's Lombardi Comprehensive Cancer Center in Washington, D.C. "It raises a concern about this, and there's a scientific rationale to be concerned about. We can't say anything conclusively but there are options, other types of antidepressants, other types of medications, that don't have that impact. The cautious thing to do is to choose other medications while trying to sort this out."

Marcom agreed. He also noted that breast cancer-inhibiting medications called aromatase inhibitors, which include letrozole (Femara) and exemestane (Aromasin), "are one possible alternative to tamoxifen. There are also genotyping issues -- how different individuals metabolize the various drugs. This is not standard of care but it can be checked."More information


SOURCES: Claudine Isaacs, director, clinical breast cancer program, Georgetown's Lombardi Comprehensive Cancer Center, Washington, D.C.; P. Kelly Marcom, M.D., breast oncologist, Duke Comprehensive Cancer Center, and director, Duke Hereditary Cancer Clinic, Durham, N.C.; May 30, 2009, presentations, American Society of Clinical Oncology annual meeting, Orlando, Fla.

SATURDAY, May 30 (HealthDay News) --Surgery is no longer the best treatment option for most patients with advanced colorectal cancer that has spread to other organs, a new study suggests.

Immediate colon resection (surgical removal) following diagnosis of stage IV metastatic colorectal cancer had previously been the standard procedure, followed by chemotherapy several weeks after the operation. Surgery was thought to guard against symptoms and complications from the primary tumor, which chemotherapy was thought not to affect.

However, "if the colon tumor is not causing obstruction, perforation or bleeding, we've found these patients are best treated with chemotherapy. By moving straight to chemotherapy, patients can avoid the risk of surgical complications and can start treatment for all sites of disease without delay," study author Philip Paty, a surgical oncologist at Memorial Sloan-Kettering Cancer Center, said in a news release issued by the center.

The recommendation is based on a finding that 93 percent of advanced metastatic colorectal cancer cases treated over a six-year period at Sloan-Kettering did not present the complications that failure to remove the primary tumor were expected to cause. Advances in chemotherapy that do a better job at shrinking both the primary colon tumor and the metastases are thought to be responsible for this change.

"We now know that the routine use of surgery for these patients is based on old thinking, and we're beyond that. There will always be the need for individual exceptions based on the clinical situation, but our default position should be not to operate," said Paty, who plans to present the findings Saturday at the American Society of Clinical Oncology annual meeting, in Orlando, Fla.

Colorectal cancer is the second leading cause of cancer-related death in the United States.More information

-- Kevin McKeever

SOURCE: Memorial Sloan-Kettering Cancer Center, news release, May 30, 2009

SATURDAY, May 30 (HealthDay News) -- A two-drug combination treatment proved successful in safely slowing advanced non-small cell lung cancer in a recent clinical trial.

In the study, a phase 3 trial involving 768 people with the disease, those who had erlotinib (Tarceva) added to their dose of the bevacizumab (Avastin) saw the progression of the disease slow more than if on bevacizumab alone. People on the combo therapy tolerated the drugs well and survived an average of 4.8 months before the disease grew worse, compared with 3.7 months for those on bevacizumab alone.

Non-small cell lung cancer, often linked to past tobacco use, is the most common of all lung cancers, according to the National Cancer Institute.

"This is the first study to show the addition of erlotinib to maintenance therapy prolongs progression-free survival in patients with advanced non-small cell lung cancer," the study's co-author, Dr. Vincent Miller, a thoracic oncologist at Memorial Sloan-Kettering Cancer Center in New York City, said in a news release from the center. "Knowing which patients will get the greatest benefit from this combination, based on the identification of biomarkers, will be an important next step in this research."

Maintenance therapy aims to slow a disease from getting worse and better the chance of surviving while recovering from stronger chemotherapy treatments, which can weaken and sicken the person.

Miller was to present the findings Saturday at the annual meeting American Society of Clinical Oncology, in Orlando, Fla.

Bevacizumab and erlotinib have previously shown promise in treating non-small cell lung cancer by blocking tumor growth.More information

-- Kevin McKeever

SOURCE: Memorial Sloan-Kettering Cancer Center, news release, May 30, 2009

SUNDAY, May 31 (HealthDay News) -- Using a combination of the drugs temsirolimus (Torisel) and Bryostatin appears to be safe in patients with metastatic kidney cancer, according to early data from 25 patients in a phase 1 trial.

The researchers said a pathway known as mTOR signaling promotes tumor cell proliferation and tumor blood vessel development. The temsirolimus-bryostatin combination blocks two portions of the mTOR signaling pathway, and the early data suggests the drugs may be active in patients with rare forms of renal cell cancer that are less likely to respond to other therapies.

"We have certainly seen sustained responses with this combination, which are encouraging," Dr. Elizabeth Plimack, a medical oncologist and attending physician at Fox Chase Cancer Center in Philadelphia, said in a news release from the center.

"Patients with non-clear cell renal cell cancer, including papillary renal cancer, don't respond as well to tyrosine kinase inhibitors, such as sunitinib [Sutent] and sorafenib [Nexavar], as patients with clear cell renal cell. So there is an unmet need for therapy for these patients. We've seen that this combination may be active to some degree for them," Dr. Elizabeth Plimack said.

The findings were to be presented Sunday at the American Society of Clinical Oncology annual meeting, in Orlando, Fla.

The trial is still enrolling new patients.More information

-- Robert Preidt

SOURCE: Fox Chase Cancer Center, news release, May 31, 2009

TUESDAY, June 2 (HealthDay News) -- Common drug combinations used to treat heart disease raise the risk of bleeding or perforation of the upper gastrointestinal tract, new research shows.

Researchers examined data on 78,084 patients aged 60 to 99 from a Department of Veterans Affairs national pharmacy and administrative database. About 30 percent were prescribed what is known as Complex Antithrombotic Therapy, combinations of two or three drugs, between January 2003 and September 2006.

The combinations include anticoagulant-antiplatelet (ACAP), aspirin-antiplatelet (ASAP), aspirin-anticoagulant (ASAC) or TRIP (aspirin-anticoagulant-antiplatelet).

The drugs are typically prescribed to treat people with a history of heart attack, stroke or peripheral vascular disease.

Within one year of starting the drugs, 1,061 experienced an upper gastrointestinal (GI) event, such as bleeding or perforation, requiring immediate medical attention. The upper GI tract includes the pharynx, esophagus and stomach.

Patients prescribed ASAP and ASAC drug combinations were two and a half times more likely to suffer an upper gastrointestinal event than those not taking the drugs. The fewest upper GI problems occurred among people taking ACAP.

The greatest risk came from TRIP, which correlated with a fourfold increased risk of an upper GI event, according to the study to be presented Tuesday at Digestive Disease Week 2009 in Chicago.

Younger patients -- those between 60 and 69 years old -- were at the highest risk. That age group was most likely to take the TRIP drug-combo because of a likelier history of ischemic heart disease, hypertension, diabetes and peripheral artery disease, the study found.

"The fact that triple therapy is most commonly prescribed to younger patients reflects the changes in current cardiac care," study author Dr. Neena S. Abraham, of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine in Houston, said in a Digestive Disease Week news release. "The observed magnitude of UGIE [upper gastrointestinal event] risk suggests an unfavorable risk/benefit profile for CAT [Complex Antithrombotic Therapy] in the short term."

Gastroenterologists and cardiologists need to further evaluate the risk-benefit ratio of these therapies given the twofold to fourfold increased UGIE risk, Abraham said.More information

-- Jennifer Thomas

SOURCE: Digestive Disease Week, news release, June 2, 2009

WEDNESDAY, June 3 (HealthDay News) -- Crohn's disease patients who received a combination of the drugs infliximab (Remicade) and azathioprine (Azasan) were more likely to have the disease go into steroid-free remission than those who received only one of the drugs, researchers say.

The study was presented Tuesday at Digestive Disease Week 2009 in Chicago.

Crohn's disease is an inflammation of the digestive tract, most often the lining and wall of the lower small intestine, or the ileum, according to the National Digestive Diseases Information Clearinghouse. When inflamed, the lining of the intestinal wall can become swollen, causing diarrhea. Severe cases can require surgery.

In an international study, researchers divided 508 patients with moderate to severe Crohn's who had not yet received immunomodulator drugs into three groups. One group received infliximab plus azathioprine, a second group received infliximab plus a placebo and the third group received azathioprine plus a placebo for 30 weeks, with the option to continue in a blinded study extension through week 50.

After 50 weeks, 72.2 percent of patients who'd received the infliximab/azathioprine drug combination were in steroid-free remission, compared to 60.8 percent who'd received infliximab alone and 54.7 percent who had taken azathioprine alone, according to a Digestive Disease Week news release.

The researchers used colonoscopies and a Crohn's Disease Activity Index score to measure clinical symptoms. Assuming the patients who did not enroll in the study extension continued to have Crohn's symptoms at week 50, the proportion of the patients who were in steroid-free remission at week 50 was 46.2 percent with infliximab plus azathioprine, 34.9 percent with infliximab monotherapy and 24.1 percent with azathioprine monotherapy, the study found.

Looking at all treatment groups, the percentage of patients who developed serious infections was similar in all groups, and during the study extension there were no new opportunistic infections, malignancies or deaths.

"Results of this study will provide practitioners and their patients with more clinical data on how to use these drugs most appropriately to most effectively treat Crohn's disease," study author Dr. William J. Sandborn, vice chair of the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, said in the news release. "For the first time, we have longer-term outcome data on the advantages of combination therapy that will help guide our treatment of patients with Crohn's disease."

Monoclonal antibodies, such as infliximab, are increasingly used to treat several types of gastroenterological disorders.

"The use of monoclonal antibodies is rising for a number of gastroenterological disorders, such as inflammatory bowel disease," said Dr. Nicholas J. Shaheen, of the University of North Carolina School of Medicine, in the news release. "New indications for these treatments are continuing to be developed and the safety profile is better understood, making them good treatment options for patients with recurrent or chronic gastrointestinal diseases."

This study is the first to provide longer term data on the benefits of combination infliximab-azathioprine and infliximab therapy. In the study, patients were started on the drugs earlier in the course of the disease than typically occurs, Sanborn noted.More information

SOURCE: Digestive Disease Week, news release, June 2, 2009

TUESDAY, June 2 (HealthDay News) -- Television reduces verbal interaction between parents and infants, which could delay children's language development, says a U.S. study that challenges claims that certain infant-targeted DVDs actually benefit youngsters.

The researchers studied 329 children, aged 2 months to 48 months, and found that for each additional hour of television exposure, there was a decrease of 770 words (7 percent) heard from an adult by the children. The study also found that the more hours spent watching television, the fewer vocalizations infants made when adults talked to them.

"Some of these reductions are likely due to children being left alone in front of the television screen, but others likely reflect situations in which adults, though present, are distracted by the screen and not interacting with their infant in a discernable manner," wrote Dr. Dimitri A. Christakis, of Seattle Children's Hospital, and colleagues.

"At first blush, these findings may seem entirely intuitive. However, these findings must be interpreted in light of the fact that purveyors of infant DVDs claim that their products are designed to give parents and children a chance to interact with one another, an assertion that lacks empirical evidence," they noted.

The researchers added that their results may help explain previous findings of a link between television viewing and delayed language development.

"Given the critical role that adult caregivers play in children's linguistic development, whether they talk to their child while the screen is on may be critical and explain the effects that are attributed to content or even amount of television watched," the team wrote. "That is, whether parents talk less (or not at all) during some types of programs or at some times of the day may be as important in this age group as what is being watched."

The study appears in the June issue of the Archives of Pediatrics & Adolescent Medicine.More information

-- Robert Preidt

SOURCE: JAMA/Archives journals, news release, June 1, 2009

By Ed Edelson: HealthDay Reporter

FRIDAY, May 22 (HealthDay News) -- Younger men diagnosed with advanced prostate cancer don't live as long as older men facing the same diagnosis, a new study finds.

"Overall, young men with prostate cancer do quite well, although the young men that have more advanced prostate cancers did substantially worse than old men with similar forms of the disease," said Dr. Daniel W. Lin, lead author of a report in the July 1 issue of Cancer. "Among men with high-grade and high-stage prostate cancers, younger men are approximately three times more likely to die of prostate cancer than all other age groups."

The finding comes from an analysis of outcomes of 318,774 men listed in a national database of prostate cancer whose diagnosis was made between 1988 and 2003. That analysis also showed that over time, more American men are being diagnosed with prostate cancer at an earlier age, likely because of more intensive screening programs.

The study results add more doubts about the value of such screening programs, said Dr. Otis W. Brawley, chief medical officer of the American Cancer Society. "Men with high-grade tumors are less likely to benefit from screening," Brawley said.

But the results drew exactly the opposite reaction from Dr. Stephen Freedland, an associate professor of urology and pathology at Duke University. "Really young men, those 35 to 44, have worse cancers," Freedland said. "This is not a group of men where we typically screen for prostate cancer. The percentage of metastatic disease is higher than for any other group. This is a failure of early diagnosis."

The finding thus lends support to the recent recommendation by the American Urological Association that men should have a first screening test for prostate-specific antigen (PSA) at age 40, Freedland said.

The lessons Lin, who is chief of urologic oncology at the University of Washington, drew from the study were not primarily about screening. "This might give some insight into prostate cancer in younger men," Lin said. "We could identify high-risk cases earlier, and thus enroll those men into clinical trials. With current treatment options limited, this is a call in part for considering clinical trials and ongoing studies of new treatments."

So for physicians treating prostate cancer, "our message is that younger men with high-grade cancers do very poorly, and when you find one, be aware that it should be treated aggressively and with experimental methods if necessary," Lin said.

PSA screening is now a major issue, with a controversy triggered by two recent reports indicating that routine screening is relatively ineffective at reducing prostate cancer deaths.

Screening recommendations by major organizations vary widely, Brawley noted, with some groups, including the American Association of Family Physicians, flatly against such programs. The American Cancer Society guidelines, which now are under review, call for a physician to discuss, but not necessarily offer, a PSA test to men with normal risk at age 50, and to high-risk men at 45.

Men at higher risk are those with a father or brother who has had the disease, and black men, who are more likely to develop prostate cancer for unknown reasons, Brawley said.

The new study supports the recommendation for earlier screening, Freedland said. "These are men that have 30 to 40 years to live, and will have the most benefit from screening," he said.More information

SOURCES: Daniel W. Lin, M.D., chief, urologic oncology, University of Washington, Seattle; Otis W. Brawley, M.D., chief medical officer, American Cancer Society, Atlanta; Stephen Freedland, M.D., associate professor, urology and pathology, Duke University, Durham, N.C.; July 1, 2009, Cancer

THURSDAY, May 21 (HealthDay News) -- The chances of having to have a limb amputated because of diabetes were reduced by 36 percent when people with type 2 diabetes were given the drug fenofibrate to lower their blood fat levels, new research has found.

The study included 9,795 people, ages 50 to 75, who took either 200 milligrams of fenofibrate or a placebo daily for five years. The researchers reported that 115 people had lower-limb amputations attributed to diabetes.

People with previous cardiovascular disease, microvascular disease, previous non-traumatic amputation or skin ulcer, smoking and a longer duration of diabetes were more likely to have amputations than those who had other cardiovascular problems or those who had neither cardiovascular issues or amputations.

The risk of a first amputation was 36 percent lower among people taking fenofibrate than those taking the placebo. The study also found that people in the fenofibrate group had a 47 percent lower risk of amputations below the ankle and without large-vessel disease in the amputated limb. The researchers considered the status of large-vessel disease to distinguish amputations related to large-artery atherosclerosis from those related to diabetic microvascular disease.

The study found virtually no difference in the risk for amputations above the ankle between those who did and did not take fenofibrate.

Height was found to be a major predictor of amputations, with a 1.6-fold increase for every additional 10 centimeters in height.

"Classic markers of macrovascular and microvascular risk were associated with lower-extremity amputations in patients with type 2 diabetes," concluded Professor Anthony Keech, of the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney, in Australia, and his colleagues.

"These findings could lead to a change in standard treatment for the prevention of diabetes-related lower-limb amputations," they concluded, adding that the results "showed a reduction in amputation rates that seemed to emerge after just 1.5 years of fenofibrate use."

The study was published this week in a special issue of The Lancet devoted to diabetes.More information

By Steven Reinberg: HealthDay Reporter

THURSDAY, May 21 (HealthDay News) --Diabetics who strictly control their blood sugar levels also reduce their risk of heart attack and cardiovascular disease, British researchers report.

There have been several conflicting reports about the value of dramatically reducing blood sugar levels in diabetic patients in preventing heart attack and heart disease. In fact, some have suggested that significantly lower blood sugar levels could possibly be harmful.

"We show that if you lower glucose measures by something called HbA1c by 0.9 percent over five years, you reduce heart attacks by 17 percent and fatal and nonfatal heart attacks by 15 percent," said lead researcher Dr. Kausik Ray, a senior clinical research associate from the University of Cambridge. "There is no excess risk of death in contrast to earlier claims."

The implications are enormous, Dr. Kausik Ray said. "There have been claims recently by doctors that lowering glucose to less than 7 percent could be harmful. We disprove that in the largest study to date," he said.

On average, diabetics die seven years earlier, and they need multiple interventions such as lowering blood pressure and cholesterol to reduce their risk of dying. "Despite this, the risk remains high, so better control of sugars further reduces residual risk," Ray said.

The report is published in the May 23 issue of The Lancet.

For the study, Ray's team analyzed data from five studies that included 33,040 patients. Among all these patients, there were 1,497 heart attacks, 2,318 cases of coronary heart disease, 1,127 strokes and 2,892 people died.

The researchers noted hemoglobin A1c concentrations (HbA1c) in the patients. More intensive blood sugar control was achieved when patients used additional medications and/or higher doses to get lower HbA1c levels.

HbA1c indicates the average blood sugar concentration for the preceding two to three months. In general, healthy people who do not have diabetes have HbA1c levels ranging from 4 percent to 5.9 percent, while patients with diabetes usually have HbA1c levels over 6.5 percent, the researchers noted.

Among people who received intensive treatment to control their blood sugar, their HbA1c was 0.9 percent lower than patients receiving standard treatment (6.6 percent vs. 7.5 percent).

Those whose blood sugar was strictly controlled saw a 17 percent reduction in non-fatal heart attacks, and a 15 percent reduction in events associated with heart disease, the researchers found.

"Better control of blood sugars reduces risk of heart attacks and heart disease," Ray said. "Treatment should be tailored to individual needs, however."

Dr. Theodore Mazzone, chief of the Section of Endocrinology, Diabetes and Metabolism at the University of Illinois at Chicago and author of an accompanying journal commentary, noted there have been trials that failed to show that controlling blood sugar reduced heart attacks.

"People with type 2 diabetes are at greatly increased risk for heart attack," Mazzone said. "We do know that treating them with statins and controlling their blood pressure can have a significantly beneficial effect for reducing this risk, but even after that, there still is residual incremental risk compared to non-diabetic patients," he said.

Taken together, the trials analyzed in this study do show a benefit in preventing heart attacks from blood sugar control, Mazzone said. "It would be premature for doctors or patients to completely discard glucose control as a strategy for managing heart attack risk in patients with diabetes," he said.

Glucose control is not as important as lowering cholesterol and blood pressure in preventing heart attacks among diabetics, Mazzone said. "The effect of glucose is going to be smaller," he said.

Adding even the small benefit for heart attack is worthwhile, because it adds to the overall benefit of glucose control in these patients, Mazzone said. It's already well established and well accepted that glucose control can minimize the risk for blindness, minimize the risk for kidney disease, minimize the risk for nerve disease.

In another report in the same journal issue, Dr. David Williams, from the Institute for Women's Health at University College London, and colleagues looked at 20 studies and found that pregnant women who develop gestational diabetes have a seven-and-a-half times increased risk of developing type 2 diabetes after giving birth.

"The increased risk in relative risk of type 2 diabetes reported in this meta-analysis might help motivate mothers to attend screening programs, and health-care professionals to increase uptake to these programs or perhaps suggest the best time for reassessment. Since the risk of type 2 diabetes seems to be maintained for several years, consideration of whether any form of continuous assessment would lead to health gains is important," the authors noted.More information

SOURCES: Kausik Ray, M.D., senior clinical research associate, University of Cambridge, England; Theodore Mazzone, M.D., professor, medicine, and chief, section of endocrinology, diabetes and metabolism, University of Illinois at Chicago; May 23, 2009, The Lancet

FRIDAY, May 22 (HealthDay News) -- Low levels of vitamin D may contribute to cancer development, U.S. researchers have found.

"The first event in cancer is loss of communication among cells due to, among other things, low vitamin D and calcium levels," study leader Cedric Garland, an epidemiologist at the Moores Cancer Center at the University of California, San Diego, said in a university news release.

Garland and colleagues developed a scientific model that suggests "this loss may play a key role in cancer by disrupting the communication between cells that is essential to healthy cell turnover, allowing more aggressive cancer cells to take over."

This cellular disruption could account for the earliest stages of many cancers, according to the study, which was published online in the Annals of Epidemiology.

Maintaining adequate levels of vitamin D may help stop cancer development, Garland suggested.

"Vitamin D may halt the first stage of the cancer process by re-establishing intercellular junctions in malignancies having an intact vitamin D receptor," Garland said.

He noted that appropriate vitamin D levels can be restored and maintained through diet and supplements. More research into the link between vitamin D and cancer is required, but Garland recommended that people get their vitamin D levels tested during annual check-ups.More information

-- Robert Preidt

SOURCE: Annals of Epidemiology, news release, May 22, 2009

FRIDAY, May 22 (HealthDay News) -- High levels of vitamin D might help keep the brain healthy as people age, new research suggests.

For the study, which included more than 3,000 European men aged 40 to 79, the researchers assessed the men's memory and how quickly they processed information. They also examined other factors that affect mental agility, such as physical activity levels and mood. Blood samples were taken to measure the men's circulating levels of vitamin D, which the body produces through exposure to sunlight and obtains through dietary sources.

The study authors found that high circulating vitamin D levels were associated with high scores on memory and information-processing tests, while low vitamin D levels were associated with poor scores. The findings appear online in advance of publication in the print issue of the Journal of Neurology, Neurosurgery and Psychiatry.

The exact link between circulating vitamin D levels and mental agility isn't clear, but it's possible that vitamin D increases certain hormonal activity or protects neurons and chemical-signaling pathways, according to the researchers.

"Previous studies exploring the relationship between vitamin D and cognitive performance in adults have produced inconsistent findings, but we observed a significant, independent association between a slower information processing speed and lower levels of vitamin D," said study author David M. Lee, of the University of Manchester in the United Kingdom, in a news release from the university.

"The main strengths of our study are that it is based on a large population sample and took into account potential interfering factors, such as depression, season and levels of physical activity," Lee added. "Interestingly, the association between increased vitamin D and faster information processing was more significant in men aged over 60 years, although the biological reasons for this remain unclear."

If vitamin D supplements can help reduce the effects of aging on the brain, the health implications could be significant because many people, particularly the elderly, are vitamin D-deficient, the researchers pointed out.More information

-- Robert Preidt

SOURCE: University of Manchester, news release, May 20, 2009

By Ed Edelson: HealthDay Reporter

MONDAY, May 25 (HealthDay News) -- Taking a cholesterol-lowering statin after a stroke reduces the risk of a second stroke, new research shows.

The 10-year study of nearly 800 people who had strokes found a 35 percent lower incidence of second strokes and a 57 percent lower death rate among those who took statins compared to those who didn't, according to a report in the May 26 issue of Neurology.

Statins include blockbuster medications such as Crestor, Lipitor, Pravachol and Zocor.

The new Greek study echoes findings from an even bigger international trial, reported in 2006, called Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL).

Together, "our study and the SPARCL study have clearly shown the benefits of statins," said Dr. Sotirios Giannopolous, assistant professor of neurology at the University of Ioannina, Greece, and lead author of the new trial.

SPARCL involved more than 4,700 individuals treated for strokes or "mini-strokes" (formally called transient ischemic attacks) at 205 medical centers around the world. It found a 16 percent reduction in second strokes, as well as a 35 percent reduction in major coronary events among participants given 80 milligrams a day of a single statin, Lipitor.

In the new Greek study, Giannopolous' team found that about 8 percent of those on statins had a second stroke, compared to 16 percent of participants not taking the medications.

The new study rounded out the SPARCL results because "we have included all statins in all dosages, thus our study reveals the drug class effect," Giannopoulos said. Based on the findings, "I would recommend administration of a statin on admission to a hospital," he said.

But Dr. Sotirios Giannopolous stressed that the cholesterol-lowering activity of a statin may not be the prime cause of related reductions in stroke. "Statins have anti-inflammatory and antioxidative effects," he said, "and [they] also prevent blood clotting and stabilize plaque in the arteries. So, one of these mechanisms may help to prevent recurrent stroke."

Reports that statins can help prevent stroke recurrence are already affecting medical practice, he said. "It is almost policy here in the United States to start statin therapy after stroke, even in patients with normal cholesterol levels," Giannopoulos said.

That is true to some extent, added Dr. Gary Abrams, an associate professor of neurology at the University of California, San Francisco.

Statins are "regularly used, certainly, by stroke experts," Abrams said. "It is unclear how well it is permeating the general medical community, but as the evidence unfolds I believe use will be more widespread."

While the Greek study has "a lot of useful information, it has certain weaknesses," Abrams said. "It doesn't really provide information about which statin to use and it doesn't provide information about dosages."

But there's no clear evidence that one statin is better than another, anyway, Abrams said. "My belief is that probably any statin is better than none at all," he said. "In terms of dosage, you have to target that to certain lipid [cholesterol] levels. Which statin? That question is still open."

Abrams agreed that the exact mechanism of action is unclear. "It depends partly on lipid-lowering, partly from reducing inflammation and partly from the direct effect on blood vessels," he theorized.More information



SOURCES: Sotirios Giannopoulos, M.D., assistant professor, neurology, University of Ioannina, Greece; Gary Abrams, M.D., associate professor, neurology, University of California, San Francisco; May 26, 2009, Neurology

THURSDAY, May 14 (HealthDay News) -- In a phase 3 clinical trial, an experimental immune-based treatment boosted by 20 percent the overall survival of those with tough-to-treat neuroblastoma, which affects mostly children.

The findings are to be presented at the American Society for Clinical Oncology annual meeting, which starts later this month in Florida.

The trial involved 226 patients newly diagnosed with high-risk neuroblastoma, a cancer of the nervous system. Standard treatment includes surgery, aggressive chemotherapy with "stem cell rescue" (where the patient's stem cells are removed before treatment, then returned after chemotherapy to boost blood/immune function) and radiation therapy.

"Even though we treat it with aggressive therapy, high-risk neuroblastoma often returns, and most patients do not survive," Dr. Alice Yu, a professor of hematology/oncology at the University of California, San Diego, and the school's Moores Cancer Center, said in a news release from the society.

The new immune-based treatment -- called chimeric anti-GD2 antibody ch14.18 -- targets a key sugar-and-fat molecule lying on neuroblastoma cells called GD2. Left alone, the molecule inhibits the immune system from attacking the cancer cells. But the new antibody binds to GD2, encouraging such attacks, the researchers explained.

In the new trial, half of the patients received chemotherapy/stem cell rescue plus standard treatment (retinoic acid), as well as the new immunotherapy. The others received standard treatment only.

After two years, the number of participants who had survived without a relapse reached 66 percent in the immunotherapy groups, compared with 46 percent among those who did not get the new treatment. Overall survival after two years reached 86 percent in the immunotherapy cohort and 75 percent among those who got standard treatment.

"It is very exciting to have a new treatment option for this disease," Yu said, "and we hope to make this immunotherapy available to more children with neuroblastoma."

The study is to be presented June 2 at the meeting but was described in a news conference Thursday.More information

-- E.J. Mundell

SOURCE: American Society of Clinical Oncology, news release, May 14, 20

By Steven Reinberg: HealthDay Reporter

TUESDAY, May 19 (HealthDay News) -- Men taking Flomax to treat an enlarged prostate face more than double the risk for serious complications should they need cataract surgery, a new Canadian study has found.

It's not the first time that Flomax (tamsulosin) has been linked to cataract complications. A study in 2005 found that men taking Flomax or other alpha-blockers before cataract surgery had complications during and immediately after the procedure. The U.S. Food and Drug Administration called for stronger warnings about the drug, and Boehringer Ingelheim Pharmaceuticals, which makes Flomax, sent warning letters to doctors about the potential problems.

In the new study, 7.5 percent of the men who had taken Flomax in the two weeks before cataract surgery had a serious complication, compared with 2.7 percent of those who had not taken the drug, for a 2.3 times greater risk.

The problems were not found to the same extent among men taking other alpha-blockers, said the lead researcher, Dr. Chaim M. Bell, a scientist at the Keenan Research Centre at St. Michael's Hospital in Toronto and assistant professor at the University of Toronto.

"Patients that were prescribed tamsulosin had an over twofold increase in their risk of adverse events after cataract surgery," Bell said. The findings are in the May 20 issue of the Journal of the American Medical Association.

Whether stopping the drug before cataract surgery would reduce the risk of complications is not clear, he said. But before taking Flomax, people should be made aware of the risks, including the risk associated with cataract surgery, Dr. Chaim M. Bell said.

In addition, he said, surgeons need to know if a patient is taking Flomax so that the procedure can be adjusted to take the risks into account. "A better system needs to be in place to better identify patients taking Flomax so that surgeons can best prepare during the operation," he said.

A spokeswoman for Boehringer Ingelheim said the drug maker continues to stand behind its product and believes Flomax is safe when used in the prescribed manner.

"Boehringer Ingelheim is analyzing the data to determine whether it will impact our understanding of the risks and benefits of Flomax capsules in any way," said company spokeswoman Susan Holz.

Information given doctors and patients states "that if patients are considering cataract surgery, they should tell their eye surgeon if they are taking or have taken Flomax," Holz said. "This information is also included in all patient communications regarding Flomax. The Flomax Prescribing Information also states that the patient's eye surgeon should be prepared for possible modifications to the surgical technique for any patient who has taken Flomax."

For the study, Bell's team collected data on 96,128 Canadian men, 66 years and older, who had cataract surgery between 2002 and 2007. Among them, 3,550 had taken Flomax in the two weeks before cataract surgery, and 1,006 had taken the drug more than two weeks before their surgery. In addition, 9,109 men had been taking similar drugs.

In the two weeks after surgery, 284 of the men had a serious complication. Of these, 175 underwent another operation because of a lost lens or lens fragment, 35 had retinal detachment and 26 had both complications. An additional 100 had suspected inflammation within or around the eye.

Flomax is often prescribed to treat an enlarged prostate, a condition known as benign prostatic hyperplasia, or BPH, which affects almost three of four men 70 and older. Symptoms include difficulty urinating. Flomax accounted for $1 billion in sales in 2007, according to the researchers.

Dr. David F. Chang, a clinical professor of ophthalmology at the University of California, San Francisco, said that the study strengthens the existing evidence about risks associated with taking Flomax before cataract surgery.

Most doctors who perform cataract surgery, Chang said, would not start taking the drug themselves if they knew they were likely to need cataract surgery. "If we ophthalmologist were patients, we would want to hear about some of the options," he said. "If I needed cataract surgery, I might want to put off taking any alpha-blocker or possibly take another drug."

Chang was a researcher on the original study that linked Flomax with cataract surgery complications, and "this study supports the observations we laid out," he said.

But, he said, because the risks of complications are relatively small, men who are already taking Flomax should not stop taking the drug and should not be afraid to undergo cataract surgery. "The risks are acceptable," he said. "On the other hand, it would be a shame to have a patient start on an elective medicine like Flomax within a few months of when they need cataract surgery."More information

SOURCES: Chaim M. Bell, M.D., Ph.D., scientist, Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, and assistant professor, University of Toronto; David F. Chang, M.D., clinical professor, ophthalmology, School of Medicine, University of California, San Francisco; Susan Holz, spokeswoman, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conn.; May 20, 2009, Journal of the American Medical Association

By Kathleen Doheny: HealthDay Reporter

THURSDAY, May 21 (HealthDay News) -- Babies delivered by elective, repeat cesarean section delivery are nearly twice as likely to be admitted to the neonatal intensive care unit (NICU) than those born vaginally after the mother has previously had a c-section, a new study finds.

These c-section babies are also more likely to have breathing problems requiring supplemental oxygen, the researchers say.

"In addition, the cost of the birth for both mother and infant was more expensive in the elective repeat c-section group compared to the vaginal birth after c-section (VBAC) group," noted Dr. Beena Kamath, the study's lead author and a clinical instructor of pediatrics at the University of Colorado School of Medicine, Denver.

The study appears in the June issue of Obstetrics & Gynecology.

Nationwide, the c-section delivery rate keeps rising. According to the study authors, by 2006, 31.1 percent of deliveries in the United States were done this way.

Furthermore, women who have delivered once by c-section have a greater than 90 percent chance of undergoing another, the authors noted. But experts continue to debate whether these women should try labor and vaginal delivery, or automatically undergo another c-section, as there are risks are associated with each method.

To help clarify those risks, Kamath and her colleagues turned to records from the perinatal database at the University of Colorado Denver. Those records ran from late 2005 through mid-2008 and focused on babies born to 343 women who had planned a repeat, elective c-section and another 329 who planned to try vaginal birth after having previously had a baby via c-section.

The researchers looked at the differences between groups in newborn admissions to the neonatal ICU and the need for oxygen for breathing problems, as well as cost differences.

Kamath's team further divided the women into four groups. Of the 343 repeat c-sections, 104 went into labor before the c-section and 239 did not. Of the 329 women who attempted vaginal delivery, 85 failed (for various reasons) and went on to have a c-section.

Kamath's team found that 9.3 percent of the c-section babies were admitted to the NICU, but just 4.9 percent of the vaginally delivered babies were. And while 41.5 percent of the c-section babies required oxygen in the delivery room, 23.2 percent of the vaginally delivered babies did. After NICU admission, 5.8 percent of the c-section babies needed the oxygen compared to 2.4 percent of the vaginally delivered babies.

The median hospital stay was three days for babies who were delivered vaginally and four days for the other three groups. Total costs for the c-section group averaged $8,268; for the vaginal group, $6,647.

"The failed VBAC babies required the most resuscitation and had the most expensive total birth experience," Kamath concluded. But, overall, the VBAC group did better than the c-section group in terms of hospital stay and other measures, she said.

Women who opt for a repeat c-section should first understand these risks and differences before they make their decision, Kamath said.

The study results suggest another important take-home point, according to Dr. Alan Fleischman, senior vice president and medical director for the March of Dimes, based in White Plains, N.Y. "The decision to have your first c-section is very important," he said. "There should be a clear medical indication [because] your first may dictate subsequent [delivery methods]."

Women also need to know that vaginal delivery is possible for many women who have already undergone a c-section, Fleischman said. Some hospitals do not allow vaginal delivery after a prior c-section, however, so he suggested that any woman who is planning on one find out early on what her hospital's policy is.

In the same issue of the journal, other researchers found that the chance of a pregnant woman having a hypertensive disorder -- such as high blood pressure that first occurs during the pregnancy -- has risen greatly in recent years, from about 67 per every 1,000 deliveries in 1998 to more than 81 per 1,000 deliveries in 2006.

This increase, in turn, is boosting the number of hospitalizations associated with health problems in the mother-to-be, such as kidney failure or breathing problems, according to researchers at the U.S. Centers for Disease Control and Prevention.More information

SOURCES: Beena Kamath, M.D., M.P.H., clinical instructor, pediatrics, University of Colorado School of Medicine, Denver; Alan Fleischman, M.D., senior vice president and medical director, March of Dimes, White Plains, N.Y.; June 2009, Obstetrics & Gynecology

THURSDAY, May 14 (HealthDay News) --Implanted cardioverter defibrillators (ICDs) extend heart patients' lives even eight years after implantation, new research shows.

The finding was to be presented Thursday at the Heart Rhythm Society annual meeting, in Boston.

"This study proves that ICD therapy, sustained for over eight years, does in fact improve survival rates and ultimately save lives," study author Dr. Ilan Goldenberg, of the University of Rochester Medical Center, N.Y., said in a heart society news release.

In the study, the researchers tracked outcomes for more than 1,200 patients with ischemic left ventricular dysfunction who enrolled in the study in 2001.

After eight years of follow-up, 61 percent of patients without an ICD had died of any cause, compared to 45 percent of those with the implanted device. The 16 percent jump in survival equals an average gain in life span of 1.2 years over the eight-year period, the team said.

Long-term effectiveness of the devices was enhanced among patients who received some left ventricular pacing and among those who did not go on to develop heart failure, the researchers added.More information

-- E.J. Mundell

SOURCE: Heart Rhythm Society, news release, May 14, 2009

WEDNESDAY, May 20 (HealthDay News) -- A combination of aspirin and the anti-clotting drug dipyridamole reduces blockages and extends the useful life of new artery-vein access grafts used for kidney dialysis, new research has found.

When arteriovenous (AV) grafts fail, it is often due to stenosis -- a narrowing of blood vessels -- at the graft site, and subsequent clotting. If the AV graft is blocked, it can't be used for dialysis, and this is a major cause of declining health in dialysis patients, according to background information in a U.S. National Institute of Diabetes and Digestive and Kidney Diseases news release about the study.

In the study from the Dialysis Access Consortium, 649 patients with new AV grafts at 13 sites in the United States were randomly assigned to the combination treatment or placebo. The researchers found that the combination treatment decreased the rate of loss of primary unassisted graft patency (the useful life of a graft before it's blocked for the first time) by 18 percent and the rate of developing significant stenosis by 28 percent.

"Our trial results show that we now have a drug therapy that significantly prolongs the viability of AV grafts. This is an important step forward as we proceed to develop therapies to improve dialysis patients' quality of life," lead author Dr. Bradley S. Dixon, of the University of Iowa College of Medicine in Iowa City, said in the news release.

The study, which was supported by Boehringer Ingelheim Pharmaceuticals, Inc., appears in the May 21 issue of the New England Journal of Medicine.

"This drug combination provides a modest but important new therapy to keep AV grafts in good working order so patients can get the dialysis they need. But clearly, more research is needed to extend the useful life of AV grafts," Dr. Griffin P. Rodgers, director of the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, said in the news release. The institute also supported the study.

Kidney failure affects more than half a million people in the United States, and 70 percent of them are on dialysis, according to background information in the news release.More information

-- Robert Preidt

SOURCE: U.S. National Institute of Diabetes and Digestive and Kidney Diseases, news release, May 20, 2009

MONDAY, May 18 (HealthDay News) -- A new aerosol spray may help keep the airways of cystic fibrosis patients moist and clear, researchers say.

Using a special agent called GS-9411, the spray prevents sodium from being absorbed too quickly, which is a common problem for people with cystic fibrosis. The quick absorption of sodium from the surface of the airway causes their airways to dry, and allows mucous and bacteria to accumulate.

In tests on airway surface cells grown in a laboratory, GS-9411 helped the cells retain moisture for more than eight hours while tests on animals found the spray helped clear excessive mucus for at least four hours.

The findings were presented Sunday at the American Thoracic Society's annual international conference in San Diego.

"GS-9411 administered by aerosol can effectively increase airway surface liquid and enhance mucous clearance in an animal model," study author Andrew Hirsh, senior director of drug discovery and preclinical development for Parion Sciences, a pharmaceutical company, said in a news release. "The results demonstrate that GS-9411 warrants further investigation as a new drug therapy to decrease respiratory infection and improve pulmonary function."

In cystic fibrosis, a genetic defect causes the airway to absorb sodium, and therefore moisture, too quickly. When the airway is too dry, the body can't clear mucus, a key defense mechanism of the respiratory system, Andrew Hirsh said. This deficiency can cause cystic fibrosis patients to have chronic respiratory infection and impaired lung function, he explained.

"The potency and the length of time that the drug was effective in cells and in animal studies was an outstanding feature that distinguishes this compound from other agents," he said.More information

-- Kevin McKeever

SOURCE: American Thoracic Society, news release, May 17, 2009

FRIDAY, May 15 (HealthDay News) -- Researchers claim to have found a way to better customize the treatment of prostate cancer.

Four risk factors that can help predict how long men could survive with metastatic prostate cancer have been identified by researchers from the Duke Comprehensive Cancer Center, who say such information would help doctors individualize treatments.

"There is a need for identification of accurate and simple-to-use prognostic factors for men with prostate cancer that has spread beyond the prostate," Andrew Armstrong, a medical oncologist at Duke and the lead investigator for the study, said in a university news release. "Our study was aimed at developing accurate predictors which may be used to assist in clinical decision making and also in planning clinical trials for men whose disease has stopped responding to hormone therapy."

By studying the records of more than 1,000 men who were taking part in a study of the chemotherapeutic drug docetaxel and its effect on metastatic prostate cancer, the researchers found four risk factors that predicted how well someone would respond to treatment:

"Using these predictors, we were able to assign patients to risk groups of good -- indicating an average survival of about two years; intermediate -- with survival of about 1.5 years; and poor -- with survival of less than a year," Armstrong said.

"By knowing a patient's prognosis and expected responses to chemotherapy, we are better able to discuss and determine whether a more- or less-aggressive treatment plan might be advisable," he said.

Another benefit is long-range knowledge, Armstrong said. Identifying men's prognoses and how they are expected to respond to treatment also would help determine whether a drug is ready for a phase 2 trial, which test a treatment that has been shown to help some people. It usually compares a newer treatment to the gold standard, or best-known treatment.

"We're eager to use this information to accurately estimate what to expect with current therapies," Armstrong said.

The findings are to be made available to those attending the American Society of Clinical Oncology's annual meeting in Orlando, Fla., in late May.More information

-- Dennis Thompson

SOURCE: Duke University, news release, May 14, 20