Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial

Background: Patients with type 2 diabetes are at high risk of fatal and non-fatal myocardial infarction and stroke.There is indirect evidence that agonists of peroxisome proliferator-activated receptor 7 (PPAR 7) could reduce macrovascular complications.Our aim, therefore, was to ascertain whether pioglitazone reduces macrovascular morbidity and mortality in high-risk patients with type 2 diabetes. Methods:We did a prospective, randomised controlled trial in 5238 patients with type 2 diabetes who had evidence of macrovascular disease.We recruited patients from primary-care practices and hospitals.We assigned patients to oral pioglitazone titrated from 15 mg to 45 mg (n=2605) or matching placebo (n=2633), to be taken in addition to their glucose-lowering drugs and other medications.Our primary endpoint was the 1 Investigators listed at end of paper