FDA Avandia recommendation welcomed by Endocrinologists

Aug 1 2007

The American Association of Clinical Endocrinologists (AACE), along with the rest of the medical community, has watched with concern the debate regarding usage of GlaxoSmithKline's rosiglitazone (Avandia) in diabetes and the question of whether it increases cardiovascular risk.

AACE welcomes the recommendation of the Food and Drug Administration endocrine advisory panel, which voted almost unanimously yesterday that Avandia remain in the US market.

At the same time, AACE recognizes the strong statement of the panel that the drug may increase risk of cardiovascular disease (CVD). We share the concerns of many on the panel that the methodology used in suggesting an association between Avandia and CVD was far from optimal. Three well-designed long-term randomized controlled studies, the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D), the Action to Control Cardiovascular Risk in Diabetes (ACCORD), and the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trials, will greatly enhance our understanding of whether or not this agent helps to decrease diabetes complications.

Physicians can continue to treat persons with diabetes who are well-controlled with Avandia, knowing that it has been shown useful and effective in controlling glucose, a crucial step to preventing diabetes complications. AACE will continue to support the development of approaches to manage the issues of weight gain, of fluid retention, and of reduced bone mass in diabetic patients receiving both Avandia and Takeda's pioglitazone (Actos), to optimize clinical decision-making in the appropriate use of these important glucose-lowering medicines.

http://www.aace.com/