Rosiglitazone — Continued Uncertainty about Safety

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Abstract
On May 21, 2007, the Journal published a meta-analysis by Nissen and Wolski1 that indicated an increased cardiovascular risk associated with rosiglitazone (Avandia), a thiazolidinedione used to treat type 2 diabetes. We published this analysis because it indicated an increase of about 40% in the risk of myocardial infarction among patients receiving rosiglitazone as compared with those receiving either an alternative oral diabetes therapy (metformin or a sulfonylurea) or placebo. Since rosiglitazone is widely used for the treatment of type 2 diabetes and since the analysis considered all publicly available data on the topic, we published the article to make health care professionals and their patients aware of these potential adverse effects. Although we ensured that the article1 and accompanying editorial2 spelled out both the strengths and the weaknesses of the analysis, we knew that a patient-level analysis performed by the manufacturer of rosiglitazone confirmed the findings.3 The article raised substantial uncertainty about the cardiovascular safety of rosiglitazone. Even a small increase in cardiovascular risk in a fragile population of patients with type 2 diabetes is of considerable concern.

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