Polypill decreases MACE in developing countries (PolyIran)

Reference

Roshandel G, Khoshnia M, Poustchi H, et al. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. Lancet 2019;394(10199):672-683.

Synopsis

These investigators, from a region of Iran where the rate of cardiovascular events is much higher than in industrialized countries, randomly assigned adults older than 50 years to receive a daily polypill (hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg; n = 3421; 120 clusters) or to a control group (n = 3417). The randomization took place at the village level rather than at the individual level. This is generally good when there is concern that an intervention, such as an educational program or quality improvement initiative, could bleed over to the control patients. In this case, however, the chosen method was peculiar. Patients in both groups received "minimal care" consisting of educational training about a healthy lifestyle (healthy diet with low salt, sugar, and fat content; exercise; weight control; and abstinence from nicotine and opium). There was no placebo administered to control patients. In the event that a patient who was receiving the polypill developed a cough, which happened in 14%, the researchers had a backup pill that contained valsartan 40 mg in place of the enalapril. At baseline approximately 10% of the participants had pre-existing cardiovascular disease. After 5 years, the primary outcome of MACE (defined as nonfatal myocardial infarction and unstable angina, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularization procedures, and nonfatal and fatal stroke) occurred in 6% of those taking the polypill and 9% of the control patients (number needed to treat = 35, 95% CI 25 - 60). There was no difference in the overall mortality rate or in the rate of adverse events.