The Cardiovascular Safety of Diabetes Drugs - Insights from the Rosiglitazone Experience

A signal of cardiovascular harm with rosiglitazone led to a new FDA policy on diabetes-drug approval. As that signal has faded in recent analyses, should FDA policy change? The management of type 2 diabetes has been challenged by uncertainty about possible cardiovascular effects related to treatment intensity and choice of drug. Although the Food and Drug Administration (FDA) considers a decrease in glycated hemoglobin an approvable end point, very intensive glycemic control is associated with increased cardiovascular and all-cause mortality.(1) The safety of specific drugs for type 2 diabetes particularly the thiazolidinediones has also been questioned. After rosiglitazone had been approved in the United States in 1999 and in Europe in 2000, a highly publicized meta-analysis in 2007 reported a 43% increase in myocardial infarction (P=0.03) ...