A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk

Background: Most individuals at high cardiovascular disease (CVD) risk worldwide do not receive any or optimal preventive drugs. We aimed to determine whether fixed dose combinations of generic drugs (`polypills?) would promote use of such medications. Methods: We conducted a randomized, open-label trial involving 623 participants from Australian general practices. Participants had established CVD or an estimated five-year CVD risk of 15 , with indications for antiplatelet, statin and 2 blood pressure lowering drugs (`combination treatment?). Participants randomized to the `polypill-based strategy? received a polypill containing aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg. Participants randomized to `usual care? continued with separate medications and doses as prescribed by their doctor. Primary outcomes were self-reported combination treatment use, systolic blood pressure and total cholesterol. Results: After a median of 18 months, the polypill-based strategy was associated with greater use of combination treatment (70 vs. 47 ; relative risk 1.49, (95 confidence interval (CI) 1.30 to 1.72) p