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

Publication date: 24–30 August 2019Source: The Lancet, Volume 394, Issue 10199Author(s): Gholamreza Roshandel, Masoud Khoshnia, Hossein Poustchi, Karla Hemming, Farin Kamangar, Abdolsamad Gharavi, Mohammad Reza Ostovaneh, Alireza Nateghi, Masoud Majed, Behrooz Navabakhsh, Shahin Merat, Akram Pourshams, Mahdi Nalini, Fatemeh Malekzadeh, Masoumeh Sadeghi, Noushin Mohammadifard, Nizal Sarrafzadegan, Mohammad Naemi-Tabiei, Abdolreza Fazel, Paul BrennanSummaryBackgroundA fixed-dose combination therapy (polypill strategy) has been proposed as an approach to reduce the burden of cardiovascular disease, especially in low-income and middle-income countries (LMICs). The PolyIran study aimed to assess the effectiveness and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease.MethodsThe PolyIran study was a two-group, pragmatic, cluster-randomised trial nested within the Golestan Cohort Study (GCS), a cohort study with 50 045 participants aged 40–75 years from the Golestan province in Iran. Clusters (villages) were randomly allocated (1:1) to either a package of non-pharmacological preventive interventions alone (minimal care group) or together with a once-daily polypill tablet (polypill group). Randomisation was stratified by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the unit of randomisation. We used a balanced randomisati...
Source: The Lancet - Category: General Medicine Source Type: research