The Record on Rosiglitazone and the Risk of Myocardial Infarction

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Abstract
In this issue of the Journal, 1 Home and colleagues report interim results from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes, or RECORD, study (NCT00379769). The RECORD study is a 6-year, open-label, noninferiority trial in which patients with type 2 diabetes who had inadequate glucose control with metformin or sulfonylurea alone were randomly assigned to receive rosiglitazone (Avandia) or the combination of metformin and sulfonylurea. The primary outcome was a composite of hospitalization and death from cardiovascular causes. As of March 2007, data were available on the 4447 patients randomly assigned to receive one of these treatments and followed for a mean of 3.75 years. Rosiglitazone was associated with a small, nonsignificant increase in the risk of the primary outcome (hazard ratio, 1.08; 95% confidence interval [CI], 0.89 to 1.31). For the fatal or nonfatal myocardial infarction outcome, the hazard ratio was 1.16 (95% CI, 0.75 to 1.81). According to the authors, “the findings are important in answering some of the safety concerns raised by the recent meta-analysis by Nissen and Wolski.”2