Anemia Drug May Raise Stroke Risk in Kidney Patients

SATURDAY, Oct. 31 (HealthDay News) -- A drug designed to fight anemia appears to double the risk of stroke in patients with diabetes and kidney disease without substantially improving their quality of life, a new study finds.

Darbepoetin alfa, marketed as Aranesp and known as an erythropoiesis-stimulating agent (ESA), is often prescribed for diabetic patients with chronic kidney disease and mild anemia.

"The benefits we assumed we would have by treating anemia were less striking and the risks were more striking," said lead researcher Dr. Marc A. Pfeffer, a professor of medicine in the cardiovascular division of Brigham and Women's Hospital in Boston.

"This provides new data for doctors and patients to make their own risk-benefit assessment," he said. "There was a perception that treating anemia would make people feel so much better that we'll take risks, but the benefit in quality of life was not as great as we thought, and there was a clear doubling of your risk for a stroke."

The report was published in the Oct. 30 online edition of the New England Journal of Medicine to coincide with its scheduled presentation at the annual meeting of the American Society of Nephrology in San Diego.

For the study, Pfeffer's team randomly assigned more than 4,000 patients with diabetes, chronic kidney disease and anemia to receive Aranesp or placebo. During the study, 632 patients receiving Aranesp died or suffered a cardiovascular event, compared to 602 of the patients receiving placebo.

As well, 101 patients taking Aranesp had a fatal or non-fatal stroke compared with 53 of the placebo patients, the researchers found. In addition, patients taking Aranesp reported only a modest improvement in their fatigue, the researchers noted.

In earlier studies, Aranesp and a similar drug, epoetin alfa, marketed as Procrit or Epogen, were linked to increased risk of death in cancer and stroke patients.

Pfeffer believes that people with more severe kidney disease, such as those on dialysis, might still find Aranesp beneficial and the risk acceptable.

"People on dialysis generally feel even worse and generally have even more severe anemia, and this class of therapy has been very helpful to them," he said.

Because the drug was beneficial to these patients, doctors assumed it would help less severely anemic patients, Pfeffer said.

"But this use of ESAs exceeded the data," he said. "Now we have the data, and we will revisit how the drug is used now."

Dr. Phillip Marsden, a professor of medicine at the University of Toronto and author of an accompanying journal editorial, said these findings mean that doctors and patients will have to discuss whether or not to start the medication.

"For most of these patients, the modest improvement in quality of life will not be enough to subject themselves to the increased risk of stroke and death," he said.

ESAs have been used for two decades, Marsden noted. "It is a bit shocking that it took us 20 years to address whether or not these drugs were safe -- and now we know more."

Dr. Ajay Singh, clinical chief of the renal division and director of dialysis at Brigham and Women's Hospital, said this "landmark study" raises the fundamental question of whether epoetin or darbepoetin should routinely be used in treating anemia of chronic kidney disease.

"Earlier studies raised the specter of increased risk with ESA treatment. This study definitively confirms that there is meaningful risk with routine use of ESAs," said Singh, also an associate professor of medicine at Harvard Medical School.

"In my own practice, I will be cautious in using ESAs for most patients with chronic kidney disease, balancing risk with benefits and reserving treatment largely for patients who need frequent blood transfusions or who are candidates for a kidney transplant," he said.

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.

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Neurotic? It could lead to asthma

NEW YORK (Reuters Health) – People who are neurotic -- they tend to worry a lot and to have emotional ups and downs -- seem to be at increased risk of developing asthma, a new study hints. Those who suffer through a divorce or other relationship conflict are also at risk for asthma, according to the study.

Animal studies have shown that chronic stress alters hormone levels, which can inflame airways making it difficult to breathe. Researchers believe that neurotic character traits may exert similar effects. If so, then helping neurotic people to calm down or "chill out" could, theoretically, reduce their risk of asthma.

Dr. Adrian Loerbroks from Heidelberg University, Germany and colleagues explored associations between neuroticism, stressful life events and asthma by surveying a sample of 5,114 men and women aged 40 to 65 years from Heidelberg and its surroundings.

Right from the start, they noticed a link between asthma and neuroticism in men, and between asthma and unemployment in both sexes. In women, having broken off a life relationship was associated with having asthma.

Among the 4,520 individuals reported to be free of asthma at the start of the study, 63 or about 2 percent, developed asthma during a median follow-up of more than 8 years, they report in the latest issue of the journal Allergy.

According to the investigators, individuals who were highly neurotic were three times more likely to develop asthma than those who were less neurotic, and breaking off a life partnership increased the risk of asthma development by more than twofold.

The link between high neuroticism and the development of asthma was present in women and men, whereas breaking off a life relationship increased asthma risk only in women.

Unemployment and death of a close person were not significantly associated with the development of asthma, the researchers note.

The researchers call for more study on personality traits, stress and asthma.

"The physiological mechanisms by which personality, stress, and emotions might influence the development or course of asthma," they note, "are still not well known."

SOURCE: Allergy, October 2009.

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New York study says menu labeling affects behavior

WASHINGTON (Reuters) – New York's mandate that fast-food restaurants post calorie information on their menus has changed consumer habits, the city said on Monday, contradicting a recent independent study showing no effect.

The city's Department of Health and Mental Hygiene released preliminary data showing evidence that people bought food with fewer calories at nine of the 13 fast-food and coffee chains included in a study on the effects of menu-labeling laws that went into effect in 2008.

Researchers surveyed more than 10,000 customers at 275 locations in early 2007 and another 12,000 this year.

They found statistically significant decreases at four chains -- McDonald's, Au Bon Pain, KFC and Starbucks -- and said diners who saw and acted on calorie information bought food containing 106 fewer calories on average than those who did not notice the postings.

All told, 56 percent of fast-food customers reported seeing the calorie information, researchers told the annual meeting of the Obesity Society in Washington.

The earlier study by researchers at New York University and Yale University, which included 1,156 adults who ate at Burger King, KFC, McDonald's and Wendy's immediately before and after the rule went into effect, found no change to consumer habits in low-income neighborhoods.

The city's researchers said their study was more representative of dining habits because it included more people over a longer period of time and not limited to outlets in low-income neighborhoods.

In July 2008, New York became the first U.S. city to require fast food restaurants to post calorie counts in large type on menu boards.

The system has since become a model for similar rules intended to combat obesity and promote good nutrition in California, other parts of New York state, the cities of Seattle and Portland, and elsewhere.

Health advocates see menu labeling as a tool for fighting obesity. About one-third of U.S. adults are obese, a condition that increases the risk of heart disease, diabetes, cancer and other medical problems, and another one-third are overweight.

Both the city and New York University studies were funded by the nonprofit Robert Wood Johnson Foundation.

Lynn Silver, assistant commissioner for New York's Bureau of Chronic Disease Prevention and Control, said government findings show diners are noticing and acting on the labels.

"Dietary change is likely to come gradually; it will start with consumers interested in making informed, healthy eating decisions and we hope industry will respond by offering more healthier choices and appropriate portion sizes," she said in a statement.

But city researchers also found that the labeling laws' influence can be overcome by restaurant marketing.

The privately held Subway restaurant chain, which has promoted its menu as a vehicle for weight loss and healthy eating, posted calorie information on some of its menus before the labeling laws went into effect in 2008.

The number of calories purchased at Subway more than doubled during the study period, which coincided with an advertising campaign to promote larger 12-inch sandwiches. The calorie gain at Subway was roughly the same as losses at seven other food chains, researchers said.

(Editing by Philip Barbara)

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Scientists identify new lethal virus in Africa

ATLANTA – Scientists have identified a lethal new virus in Africa that causes bleeding like the dreaded Ebola virus. The so-called "Lujo" virus infected five people in Zambia and South Africa last fall. Four of them died, but a fifth survived, perhaps helped by a medicine recommended by the scientists.

It's not clear how the first person became infected, but the bug comes from a family of viruses found in rodents, said Dr. Ian Lipkin, a Columbia University epidemiologist involved in the discovery.

"This one is really, really aggressive" he said of the virus.

A paper on the virus by Lipkin and his collaborators was published online Thursday on in PLoS Pathogens.

The outbreak started in September, when a female travel agent who lives on the outskirts of Lusaka, Zambia, became ill with a fever-like illness that quickly grew much worse.

She was airlifted to Johannesburg, South Africa, where she died.

A paramedic in Lusaka who treated her also became sick, was transported to Johannesburg and died. The three others infected were health care workers in Johannesburg.

Investigators believe the virus spread from person to person through contact with infected body fluids.

"It's not a kind of virus like the flu that can spread widely," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which helped fund the research.

The name given to the virus — "Lujo" — stems from Lusaka and Johannesburg, the cities where it was first identified.

Investigators in Africa thought the illness might be Ebola, because some of the patients had bleeding in the gums and around needle injection sites, said Stuart Nichol, chief of the molecular biology lab in the CDC's Special Pathogens Branch. Other symptoms include include fever, shock, coma and organ failure.

Genetic extracts of blood and liver from the victims were tested at Columbia University in New York, and additional testing was done at CDC in Atlanta. Tests determined it belonged to the arenavirus family, and that it is distantly related to Lassa fever, another disease found in Africa.

The drug ribavirin, which is given to Lassa victims, was given to the fifth Lujo virus patient — a Johannesburg nurse. It's not clear if the medicine made a difference or if she just had a milder case of the disease, but she fully recovered, Nichol said.

The research is a startling example of how quickly scientists can now identify new viruses, Fauci said. Using genetic sequencing techniques, the virus was identified in a matter of a few days — a process that used to take weeks or longer.

Along with Fauci's institute, the National Heart, Lung, and Blood Institute and Google also helped fund the research.

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On the Net:

PLoS Pathogens: http://www.plospathogens.org/home.action

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Stroke group expands time for clot-busting drugs

DALLAS – A change to stroke treatment guidelines is expanding the time that some patients can get clot-busting drugs. Current recommendations limit the use of the medicine to within three hours after the start of stroke symptoms. That treatment window is now being lengthened to 4 1/2 hours for some patients.

But the committee that made the change stressed that the earlier the treatment, the better for stroke victims.

"They should call the ambulance straight away and get moving," said Dr. Gregory del Zoppo, of the University of Washington School of Medicine in Seattle, who headed the committee for the American Heart Association Stroke Council.

The update, published online Thursday in the heart group's journal Stroke, comes after a European study last fall found stroke sufferers still benefited from getting the medicine an hour or so beyond the three-hour window.

The new guideline is expected to increase the number of people who get the treatment. Only about a third of stroke sufferers get help within three hours, and only about 5 percent get the drug now. Many people don't recognize the signs of a stroke: numbness or weakness in the face, arm or leg; trouble speaking, seeing or walking; a sudden, severe headache.

Stroke is the third leading cause of death in the U.S., with about 795,000 people suffering a new or recurrent stroke each year and more than 140,000 people dying. Strokes caused by blood clots are the most common; the clot blocks an artery supplying blood to the brain, which starves brain cells of oxygen. The drug TPA breaks up the clot and opens the artery.

Another member of the committee, Dr. Jeffrey Saver, of the University of California at Los Angeles, said some hospitals extended the time for using the clot dissolver after the European study, while many have been waiting for national guidelines.

He said the change could increase the number of people who get the drug by a third, to 7 or 8 percent of stroke victims.

Dr. Mark D. Johnson, a stroke specialist at the University of Texas Southwestern Medical Center in Dallas, said that the expanded time frame is good news but the emphasis is still on getting treatment sooner rather than later.

"If you were to arrive in 30 minutes, the chances of a better outcome are higher than if you arrive in four hours," said Johnson.

The new guideline notes that some patients should still be restricted to treatment within the three-hour period: people older than 80, those suffering from a severe stroke or with a history of stroke and diabetes or those taking anti-clotting drugs.

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On the Net:

American Stroke Association: http://www.strokeassociation.org

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