[Trial of pioglitazone for the secondary prevention of cardiovascular events in patients with diabetes mellitus type 2: insufficient evidence].

The PROactive study was a multicentre, multinational, double-blind, placebo-controlled randomised trial that was intended to show a benefit of pioglitazone in the secondary prevention of cardiovascular disease in patients with diabetes. However, the result for the primary composite endpoint was not significant. The most important secondary endpoint (time to death, myocardial infarction or cerebrovascular accident) did show a significant reduction of 16%, but any potential benefit was outweighed by a major increase in the incidence ofhospitalisation for heart failure in the pioglitazone-treated group. Moreover, in this secondary prevention trial, there was marked undertreatment with statins while no effect of pioglitazone was observed in those who did receive a statin. Finally, no adjustment was made for the poorer glycaemic control in the placebo group. Based on these data, broadening the indication for pioglitazone in patients with diabetes cannot be recommended.