Elderly people with diabetes who took the controversial drug rosiglitazone, sold under the brand name Avandia, were more likely to develop congestive heart failure and more likely to die than those receiving a similar drug called pioglitazone, sold as Actos, according to a recent report. In a surprise finding, however, the researchers found that patients taking rosiglitazone did not suffer more heart attacks or strokes than those taking pioglitazone. Rosiglitazone has been the subject of considerable controversy since 2007, when an analysis of 42 published studies concluded that the drug may dramatically increase the risk of heart attacks and other cardiovascular events, compared to various other treatments.
Researchers at Harvard Medical School used a database of Medicare beneficiaries to track 28,361 patients for up to five years. About half were treated with rosiglitazone and half were taking pioglitazone. Death rates were 15% higher among patients treated with rosiglitazone, compared to those taking pioglitazone. The researchers found that the incidence of congestive heart failure was 13% higher. “Rosiglitazone was associated with greater mortality,” according to Dr. Wolfgang C. Winkelmayer, assistant professor of medicine at the Harvard Medical School and first author of the study, published in The Archives of Internal Medicine. It should be noted the study is an observational study.
Officials at GlaxoSmithKline, which manufactures rosiglitazone, dismissed the findings, saying they are inconsistent with evidence from more rigorous randomized clinical trials. Company officials pointed out that these include interim results reported from a six-year trial involving 4,447 patients. They say that the trial found no significant increases in deaths from cardiovascular disease or other causes in patients taking rosiglitazone.
Although the current study also found no differences in heart attack and stroke rates, Dr. Winkelmayer suggested the higher death rates among patients taking rosiglitazone may be due to underlying cardiovascular disease that was never diagnosed in the elderly patients, whose average age was 78. Dr. Winkelmayer had this explanation:
In much older adults, it is possible if they do have a stroke or myocardial infarction, they might actually die immediately and never make it to the hospital for a diagnosis, so the excess cardiac events might show up as deaths.
Dr. John Buse, chief of endocrinology at the University of North Carolina School of Medicine and president of the American Diabetes Association, said that while the new study is important, it’s limited. In this regard, he observed:
This is about the tenth report suggesting that rosiglitazone is associated with excess cardiovascular problems. We don’t have proof yet.
Both the American Diabetes Association and the European Association for the Study of Diabetes have removed rosiglitazone from lists of recommended treatments for type 2 diabetes. The consumer watchdog group Public Citizen went further and called on the Food and Drug Administration to ban the drug. Public Citizen says that rosiglitazone causes liver failure, vision impairment and other serious side effects, in addition to heart problems. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, wants this study to be “the last nail in the coffin” that results in this drug being pulled off the market. Dr. Wolfe had this to say:
The big attraction of these drugs is that they are insulin-sensitizing drugs and forestall the time when someone would have to go on to insulin. But with a 15% excess mortality over even pioglitazone, which itself is dangerous, that doesn’t seem like a very good tradeoff.
A federal scientific advisory panel that reviewed rosiglitazone’s safety profile last year recommended that it remain on the market. Sales of the drug have fallen sharply. About one million Americans still take the drug, which helps control blood sugar by increasing the body’s sensitivity to insulin, often as part of a regimen that includes other diabetes medications. If you need additional information on Avandia feel free to contact Frank Woodson in our Mass Torts Section at 800-898-2034.
Source: New York Times
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