A controversial drug for type 2 diabetes has come under fire yet again. Two studies suggest that Avandia significantly increases the risk for heart attacks and other cardiovascular complications. Dr. Steve Nissen and colleagues at the Cleveland Clinic conducted one study, a meta-analysis of 56 clinical trials. They concluded that the results from more than 35,000 people with diabetes show that Avandia increases the likelihood of a heart attack by 28 to 39 percent. The manufacturer, GlaxoSmithKline, contests these findings. It reports no increased risk in six studies it conducted.
Medicare Patients
The second study is an analysis of the records of more than 200,000 Medicare patients. Dr. David Graham, a safety officer at the FDA, who conducted the analysis, found that Avandia was more likely to land patients in the hospital or the cemetery when compared to Actos, a similar type of diabetes drug. According to the FDA scientists, Avandia was associated with roughly a 25 percent increased risk for both strokes and heart failure. Dr. Graham has estimated that over a decade, nearly 50,000 people may have suffered heart attacks, strokes or death as a consequence of taking Avandia.
[Archives of Internal Medicine, July 26, 2010]
[Journal of the American Medical Association, July 28, 2010]
Follow-Up
Although these studies implicated Avandia as contributing to heart disease, this question remains quite controversial (Pharmacoepidemiology and Drug Safety, online Dec. 16, 2014). The FDA may not consider rosiglitazone a risky drug, but there is no good evidence it has any advantages over the older, cheaper metformin (Journal of Managed Care Pharmacy, Sept., 2014).
