PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events)

Introduction

Study design:

• 5238 patients with type 2 diabetes
• mean age, 62; 99% white
• hemoglobin A1c >6.5% despite treatment

advanced macrovascular disease

Treatment groups

• pioglitazone (maximum, 45 mg daily) vs placebo
• all patients received other oral hypoglycemic agents & insulin as needed to reduce HbA1c below 6.5%
• optimal antihypertensive, antiplatelet, & antihyperlipidemic therapies were provided
• ACE inhibitor, beta blocker, aspirin, statins

Results:

• mean follow-up of 35 months
• median decrease in HbA1c was significantly greater with pioglitazone than with placebo (-0.8% vs. -0.3%)
• significantly fewer pioglitazone patients started chronic insulin therapy
• pioglitazone group had a significantly lower median triglyceride level & LDL/HDL ratio than did placebo group
• median LDL level had risen significantly more with pioglitazone
• incidence of the composite endpoint of death, nonfatal myocardial infarction, or stroke was significantly lower with pioglitazone than with placebo (12% vs. 14%)
• incidence of heart failure was significantly higher with pioglitazone (11% vs. 8%), but heart failure-related mortality did not differ between the groups

More general terms

• emergency medicine

Additional terms

• pioglitazone (Actos)