The PolyIran study a pragmatic, cluster-randomised trial explored the utility of a fixed-dose polypill strategy for reducing cardiovascular disease (CVD). The polypill contained aspirin 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg and enalapril 5 mg. If participants developed a cough, they were changed to polypill two with valsartan 40mg replacing enalapril 5 mg. The polypill may be of particular interest in low income and middle-income countries (LMIC).
The trial was nested within the Golestan Cohort Study (GCS) which had 50045 participants aged between 40-75 years living within the Golestan province in Iran. Different villages were randomly allocated to receive either minimal care (a package of non-pharmacological preventative lifestyle interventions) or the minimal care plus a once-daily polypill.
The participants were followed up for 60 months and the primary outcome for the study was the occurrence of a CVD event. The PolyIran study recruited 6838 people of which 3417 received minimal care and 3421 minimal care plus the polypill. Adherence to the polypill was 80.5% and the frequency of adverse events was similar between groups.
In the minimal care group 301 (8.8%) of the participants experienced a major CVD event compared with 202 (5.9%) of the 3421 participants in the polypill group (adjusted hazard ratio [HR] 0.66, 95% CI 0.55-0.80). This difference was greater when those with high adherence were compared to the minimal care group (adjusted HR 0.43, 95% CI 0.33-0.55).
The authors conclude;
‘use of polypill was effective in preventing major cardiovascular events. Medication adherence was high and adverse events numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs.’
For further information please see:
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. The Lancet 2019, Aug, 24; 394;10199:672-683.