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Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): A pragmatic, cluster-randomized trial

The Lancet Aug 29, 2019

Roshandel G, Khoshnia M, Poustchi H, et al. - Via The PolyIran study of 50,045 participants aged 40–75 years from the Golestan province in Iran, experts evaluated the efficiency and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease. In comparison with 202 of 3,421 participants in the polypill group, 301 of 3,417 participants in the minimal care group had major cardiovascular events during follow-up. No statistically important interaction with the presence or absence of preexisting cardiovascular disease was discovered. The decrease in the risk of major cardiovascular events was even greater compared with the minimal care group when restricted to participants in the polypill group with high adherence. Among the two study groups, the frequency of adverse events was comparable. During the 5 years of follow-up, 21 intracranial hemorrhages were reported (ten participants in the polypill group and 11 participants in the minimal care group). In the polypill group and in the minimal care group, there were 13 and nine physician-confirmed diagnoses of upper gastrointestinal bleeding, respectively. Therefore, in preventing major cardiovascular events, the use of polypill was efficient. Medication adherence was high and adverse event numbers were low. The polypill approach could be recognized as a supplementary efficient component in controlling cardiovascular diseases, particularly in low-income and middle-income countries.
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