Following upon the recent conclusion from an analysis of multiple studies that diabetes drug rosiglitazone (brand name Avandia) may increase heart attack risk (see “Type 2 Drug Avandia Linked to Increased Risk of Heart Attacks”), the U.S. Food and Drug Administration (FDA) has launched its own analysis of data abut the drug. Last week, a statement from a member of Congress indicated that the preliminary results of the FDA’s evaluation show a similar magnitude of heart attack risk.
The FDA confirmed that its own analysis of multiple studies (called a meta-analysis), found heart attack rates similar to the meta-analysis published recently in The New England Journal of Medicine (NEJM). However, the FDA also stated that it has conflicting data from various studies and is therefore continuing to evaluate the results of an ongoing trial of rosiglitazone. This trial, called the RECORD trial, is a large-scale study specifically designed to look at the cardiovascular effects of rosiglitazone. Its complete results, however, will not be available until 2009.
An editorial published last week in the British medical journal The Lancet cited two previous large-scale studies that did not show any statistically significant increases in heart attack risk in people taking rosigitazone. It advised that doctors and people taking rosiglitazone “can reasonably await the results of RECORD” and should not jump to conclusions about rosiglitazone’s safety based on the results of the NEJM meta-analysis. However, the RECORD trial may be in danger of not being able to continue because some of the trial’s 4,450 participants have recently dropped out because of safety concerns. While rosiglitazone manufacturer GlaxoSmithKline did not reveal how many people had dropped out of the study, the company and the independent research committees overseeing the study have expressed concern about how to retain participants so the trial can be completed.