Abstract
A recent and provocative meta-analysis, based on few outcome events, suggested that rosiglitazone increased cardiovascular mortality and myocardial infarction. However, results of meta-analyses of trials with sparse events, often performed when examining uncommon adverse effects due to common therapies, can vary substantially depending on methodologic decisions. The objective of this study was to assess the robustness of the rosiglitazone results by using alternative reasonable methodologic approaches and by analyzing additional related outcomes. In duplicate and independently, we abstracted all myocardial and cerebrovascular ischemic events from all randomized controlled trials listed on the manufacturer's web site meeting inclusion criteria of the original meta-analysis (at least 24 weeks of rosiglitazone exposure in the intervention group and any control group without rosiglitazone). We performed meta-analyses of these data under different methodologic conditions. An unconfounded comparison that includes only trials (or arms of trials) in which medications apart from rosiglitazone are identical suggests higher risks than previously reported, making even the risk of cardiovascular death statistically significant. Alternativel...Continue Reading
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