Diabetes drug Avandia poses increased risk of death: Study

Cleveland, November 25: Elderly diabetic patients who took the controversial drug Avandia, made by GlaxoSmithKline, may face a higher risk of developing congestive heart failure and death than those taking pioglitazone (Actos), warn the findings of the latest research.

Researchers at Harvard Medical School based the findings on the analysis of the prescription records of 28,361 patients (who were Medicare beneficiaries) tracked for a period of up to five years.

According to the research headed by Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital and published in the Nov. 24 issue of Archives of Internal Medicine, the use of rosiglitazone resulted in 7 percent to 15 percent increased risk of mortality as compared to the group using pioglitazone.

“Rosiglitazone was associated with greater mortality,” said Dr. Winkelmayer, assistant professor of medicine at the Harvard Medical School and first author of the study.

The study made it clear that although there was no increase in the rate of myocardial infarctiondefine or stroke, there certainly was 11 percent to 13 percent increased risk of developing congestive heart failure for patients placed on rosiglitazone drug.

“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 cardiacdefine events might show up as deaths,” Dr. Winkelmayer commented.

The drug rosiglitazone has been in the heat of controversy since 2007 after an analysis of 42 published studies had concluded that the drug might end up increasing the risk of heart attacks and other cardiovascular events.

The officials at British based GlaxoSmithKline PLC, however, dismissed the findings as totally baseless since they were inconsistent with previous studies and maintained that Avandia is safe for the heart like other diabetes drugs. They maintained that “long-term, randomized clinical trials are considered to be the gold standard for answering safety questions and making clinical decisions about prescription medicines.”

The American Diabetes Association and the European Association for the Study of Diabetes have stopped recommending the controversial drug rosiglitazone for type 2 diabetesdefine in the wake of the recent studies.

Apart from that, Public Citizen, a consumer group and a non-profit organization, had been pressing upon the FDA (Food and Drug Administration) to ban the drug as it causes liver failure, vision impairment, and some other serious side effects, in addition to increased cardiovascular risk.

Avandia is used to treat Type 2 diabetes, linked to obesity, which occurs when the body does not produce enough insulindefine or cannot effectively use it. Nearly one million Americans still take this drug to keep their blood sugar in check.