Revista médica de Chile
versión impresa ISSN 0034-9887
CRUZ U, Ricardo y LETELIER S, Luz María. Critically appraised article: Long-term risk of cardiovascular events with rosiglitazone: A meta-analysis. Rev. méd. Chile [online]. 2009, vol.137, n.7, pp. 986-989. ISSN 0034-9887. http://dx.doi.org/10.4067/S0034-98872009000700019.
Context: Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes. Objective: To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality. Data sources: We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007. Study selection: Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12 months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events. Data extraction: Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n =14.291, including 6.421 receiving rosiglitazone and 7.870 receiving control therapy with a duration of follow-up of 1-4 years). Results: Rosiglitazone significantly increased the risk of myocardial infarction (n =94/6421 vs. 83/7870; RR, 1.42; 95% confidence interval fCIJ, 1.06-1.91; P =.02) and heart failure (n =102/6.421 vs. 62/7.870; RR, 2.09; 95% CI, 1.52-2.88; P k.001) without a significant increase in risk of cardiovascular mortality (n =59/6.421 vs. 72/7.870; RR, 0.90; 95% CI, 0.63-1.26; P =.53). There was no evidence of substantial heterogeneity among the trials for these end points (1(2) =0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascular mortality). Conclusion: Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.