Polypill with or without Aspirin in Persons without Cardiovascular Disease
Abstract
This randomized, placebo-controlled trial (TIPS-3) investigated whether a fixed-dose polypill comprising simvastatin, atenolol, hydrochlorothiazide, and ramipril, with or without aspirin could reduce cardiovascular events among 5713 individuals without established cardiovascular disease but at intermediate risk (based on INTERHEART score). The polypill alone reduced LDL cholesterol by ~19 mg/dL and systolic blood pressure by ~5.8 mm Hg, leading to a non-significant reduction in major cardiovascular events (HR 0.79; 95% CI 0.63–1.00). Aspirin alone showed modest benefit (HR 0.86; 95% CI 0.67–1.10). However, the combination of polypill plus aspirin significantly reduced cardiovascular events (HR 0.69; 95% CI 0.50–0.97), including death, MI, stroke, heart failure, and revascularization. Adherence over 4.6 years was moderate (~68% at 48 months), with more hypotension and dizziness in the polypill arms but similar bleeding rates across groups. The trial concludes that polypill plus aspirin yields meaningful cardiovascular risk reduction in primary prevention.