Loading...
In May 2007, the FDA recommended that patients who were taking rosiglitazone (Avandia) speak with their doctors about data from controlled trials that showed a “potentially significant increase in the risk of heart attack and heart-related deaths.” This recommendation was based, in large part, on the results of a meta-analysis of 42 randomized trials (Journal Watch May 24 2007) that showed rosiglitazone use was associated with significantly higher risk (odds ratio, 1.4) for myocardial infarction than the baseline rate (0.6%). Risk for cardiovascular death (baseline, 0.3%) also was higher (OR, 1.6), although this finding was of borderline significance. A reanalysis, which addressed some of the methodologic concerns about that meta-analysis, …