Researchers are reporting promising results from a five-year trial assessing the safety and effectiveness of a four-component polypill for the primary and secondary prevention of cardiovascular disease.
The PolyIran study recruited 6,838 individuals in Iran, aged between 50 and 75 years, from the Golestan cohort. Clusters were randomly allocated to either a non-pharmacological preventive intervention alone or together with a once-daily polypill tablet.
Two different formulations of polypill tablet were used. Participants were first prescribed polypill one (hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg and enalapril 5 mg). Individuals who developed a cough during follow-up were switched to polypill two, which included valsartan 40 mg instead of enalapril.
During follow-up, 8.8 per cent of participants in the minimal care group had major cardiovascular events compared with 5.9 per cent of participants in the polypill group (adjusted hazard ratio [HR] 0.66; 95% CI 0.55-0.80). With high adherence, the reduction in risk was even greater compared with the minimal care group (adjusted HR 0.43; 95% CI 0.33-0.55).
The frequency of adverse events was similar between the two study groups.
The findings are published in the Lancet.