Rosiglitazone and cardiovascular risk.

A meta-analysis of 42 clinical trials suggested that rosiglitazone, a widely used thiazolidinedione, was associated with a 43% greater risk of myocardial infarction (P = 0.03) and a 64% greater risk of cardiovascular death (P = 0.06). However, a number of criticisms have been raised that potentially undermine the conclusions of this analysis. In this article, we point out some of these limitations, summarize the currently available evidence concerning rosiglitazone and cardiovascular risk, share implications for drug safety evaluation, and offer practical recommendations to health care providers. We conclude that the data showing the increased risk for myocardial infarction and death from cardiovascular disease for diabetic patients taking rosiglitazone are inconclusive.