Efficacy and safety of pioglitazone: The proactive study

Abstract. In this paper a new analysis of the PROactive study is presented. If procedure-related endpoints (coronary and leg revascularisation) are excluded, the efficacy of pioglitazone in the prevention of all-cause mortality, non-fatal myocardial infarction and stroke, in high risk type 2 diabetic patients, is clearly shown by the study. As far as the safety issues are concerned, the reported increase in heart failure is most likely due to the greater incidence of edema in pioglitazone-treated patients.