Pioglitazone beats rosiglitazone in FDA review of controlled epidemiologic studies

Avandia critics have focused on the dearth of evidence suggesting any advantage for rosiglitazone when compared to pioglitazone. They argue that there is no good reason for anyone to take rosiglitazone instead of pioglitazone. This view receives some support from the systematic review of controlled epidemiologic studies of cardiovascular risk in patients treated with rosiglitazone or pioglitazone by Kate Gelperin, Esther Zhou and David J. Graham from the Office of Surveillance and Epidemiology. (See our previous posts here and here for additional coverage of the briefing material.)

Here are the authors’ conclusions and 3 key Forest plots (click to enlarge):


Results of a systematic review of observational studies of cardiovascular risk with rosiglitazone and pioglitazone are consistent with results of FDA’s recently completed comprehensive metaanalyses of randomized clinical trials with these drugs. It is highly likely that rosiglitazone therapy is associated with increased risk of adverse cardiovascular outcomes in patients with diabetes, compared to other available antidiabetic agents.
In the absence of any data from randomized cardiovascular outcomes trials comparing rosiglitazone and pioglitazone, it is reasonable to rely on the available body of evidence from well-designed controlled epidemiologic studies for clinical decision-making. Comparisons of rosiglitazone with pioglitazone consistently show a clinically meaningful increased risk of adverse cardiovascular outcomes, especially acute myocardial infarction, with rosiglitazone. A signal for increased all-cause mortality with rosiglitazone in older patients (>65 years of age), which was demonstrated in three well-designed observational studies, may be a reflection of the increased cardiovascular risk with rosiglitazone.

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