- Question
- Does a polypill combining a statin and several blood-pressure-lowering drugs, with or without aspirin, reduce cardiovascular events in people without prior cardiovascular disease?
- Design
- Randomized, double-blind, placebo-controlled trial with a 2-by-2-by-2 factorial design (polypill, aspirin and vitamin D), enrolling 5713 participants with a mean follow-up of 4.6 years.
- Population
- People without cardiovascular disease and with an elevated INTERHEART Risk Score, i.e. at intermediate cardiovascular risk.
- Intervention
- A once-daily polypill containing simvastatin 40 mg, atenolol 100 mg, hydrochlorothiazide 25 mg and ramipril 10 mg, with or without aspirin 75 mg daily (plus monthly vitamin D or placebo, not analyzed in this report).
- Control
- Matching placebo for the polypill, placebo for aspirin, or double placebo, depending on the comparison.
- Primary outcome
- For polypill alone and polypill plus aspirin: cardiovascular death, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure or revascularization. For aspirin alone: cardiovascular death, myocardial infarction or stroke.
- Results
- With the polypill alone, the primary outcome occurred in 126 participants (4.4%) vs 157 (5.5%) with placebo (HR 0.79; 95% CI 0.63 to 1.00). With aspirin alone it occurred in 116 (4.1%) vs 134 (4.7%) with placebo (HR 0.86; 95% CI 0.67 to 1.10). With polypill plus aspirin it occurred in 59 (4.1%) vs 83 (5.8%) with double placebo (HR 0.69; 95% CI 0.50 to 0.97).
- Safety
- Hypotension or dizziness was more frequent in the groups receiving the polypill than in their respective placebo groups.
- Conclusion
- Combined treatment with a polypill plus aspirin lowered the incidence of cardiovascular events compared with placebo in people without cardiovascular disease at intermediate risk.
- Why it matters
- It added evidence supporting a combined fixed-dose strategy in primary prevention, although the benefit came from the combination with aspirin and must be weighed against the risk of adverse effects.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026