Does rosiglitazone increase cardiovascular outcomes?

Abstract

Rosiglitazone is commonly used in the treatment of Type 2 diabetes. However, the cardiovascular outcomes with rosiglitazone have only been evaluated recently. Firstly, they were evaluated by meta-analysis. A total of 42 short-term trials, not designed to determine cardiovascular outcomes, were included in the meta-analysis. There were 72 myocardial infarctions in the control group of 12283 subjects (0.59%) and 86 in the rosiglitazone group of 15560 subjects (0.55%). This gave an odds ratio of 1.43 and a p-value of 0.03. As a consequence of this meta-analysis, the safety of this widely used medicine in subjects with Type 2 diabetes is being questioned. Interim analysis of the long-term RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes) trial, which was designed to determine cardiovascular outcomes, showed that these occurred in 9.1% of control subjects and 9.8% of the rosiglitazone subjects, and these values were not significantly different. Both the meta-analysis and the interim analysis of RECORD have many limitations. In conclusion, it seems that it is possible that rosiglitazone may have a small harmful effect on cardiovascular outcomes. As the effect (if any) is small, this should not be cause for alarm, but rather for further review of how rosiglitazone should be used and for a larger trial to determine the unequivocal effect of rosiglitazone on cardiovascular outcomes.

Keywords::

• cardiovascular outcome
• meta-analysis
• RECORD
• rosiglitazone
• Type 2 diabetes