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Int J Cardiol. 2010 Aug 20;143(2):135-40. doi: 10.1016/j.ijcard.2009.01.064. Epub 2009 Mar 27.

Cardiac safety profile of rosiglitazone: a comprehensive meta-analysis of randomized clinical trials.

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Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence.



Some meta-analyses of randomized clinical trials suggested that rosiglitazone could be associated with increased risk for myocardial infarction (MI). Available meta-analyses, based on studies sponsored by GlaxoSmithKline (GSK), failed to include all trials performed with rosiglitazone. Aim of this analysis is the assessment of the cardiovascular risk with rosiglitazone, using a comprehensive data set.


Results of 164 trials with duration >4 weeks were retrieved from and from Medline, while unpublished studies were identified from A total of 164 trials (42,922 and 45,483 patient years for rosiglitazone and comparators, respectively) were included in the analysis.


The OR for all-cause and cardiovascular mortality with rosiglitazone was 0.93[0.76;1.14] and 0.94[0.68;1.29], respectively; rosiglitazone-associated risk for nonfatal MI and heart failure was 1.14[0.90;1.45] and 1.69[1.21;2.36], respectively. The risk of heart failure was higher (2.20[1.28;3.78]) when rosiglitazone was administered as add-on therapy to insulin.


Figures for rosiglitazone-associated risk for myocardial infarction could be lower than those previously reported on the basis of a smaller number of clinical trials. No increase of all-cause or cardiovascular mortality were observed with rosiglitazone. Conversely, treatment with rosiglitazone is associated with a relevant increase in the risk of heart failure, particularly in insulin-treated patients.

[Indexed for MEDLINE]

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