Golestan University of Medical Sciences Repository

Polypill for the prevention of cardiovascular disease (PolyIran): Study design and rationale for a pragmatic cluster randomized controlled trial

Ostovaneh, M.R. and Poustchi, H. and Hemming, K. and Marjani, H. and Pourshams, A. and Nateghi, A. and Majed, M. and Navabakhsh, B. and Khoshnia, M. and Jaafari, E. and Mohammadifard, N. and Malekzadeh, F. and Merat, S. and Sadeghi, M. and Naemi, M. and Etemadi, A. and Thomas, G.N. and Sarrafzadegan, N. and Cheng, K.K. and Marshall, T. and Malekzadeh, R. (2015) Polypill for the prevention of cardiovascular disease (PolyIran): Study design and rationale for a pragmatic cluster randomized controlled trial. European Journal of Preventive Cardiology, 22 (12). pp. 1609-1617.

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Background The complexity of treatment regimens, costs and pill burden decrease the medication adherence and contribute to shortfall in cardiovascular preventive drug coverage. The polypill, a fixed dose combination pill of established drugs, is expected to increase adherence and reduce the costs whilst preventing major cardiovascular events (MCVE). Design and methods The PolyIran trial is a pragmatic cluster randomized trial nested within the Golestan Cohort Study (GCS). Subjects were randomized to either non-pharmacological preventive interventions alone (minimal care arm) or together with a polypill (polypill arm) comprising hydrochlorothiazide, aspirin, atorvastatin and either enalapril or valsartan. This study benefits from the infrastructure of the primary health care system in Iran and the interventions are delivered by the local auxiliary health workers (Behvarz) to the participants. The primary outcome of the study is the occurrence of first MCVE within five years defined as non-fatal and fatal myocardial infarction, unstable angina, sudden death, heart failure, coronary artery revascularization procedures, and non-fatal and fatal stroke. Trial status From February 2011 to April 2013, 8410 individuals (236 clusters) attended the eligibility assessment. Of those, 3421 in the polypill arm and 3417 in the minimal care arm were eligible. The study is ongoing. Conclusion The infrastructure of GCS and the primary health care system in Iran enabled the conduct of this pragmatic large-scale trial. If the polypill strategy proves effective, it may be implemented to prevent cardiovascular disease in developing countries. © European Society of Cardiology 2014.

Item Type: Article
Additional Information: cited By 3
Uncontrolled Keywords: acetylsalicylic acid; atorvastatin; enalapril; hydrochlorothiazide; liver enzyme; low density lipoprotein cholesterol; valsartan, adult; aged; Article; cardiovascular disease; cerebrovascular accident; clinical assessment; clinical effectiveness; controlled study; coronary artery recanalization; drug cost; drug effect; drug safety; fatality; female; follow up; health care personnel; heart failure; heart infarction; human; lifestyle modification; major clinical study; male; medication compliance; outcome assessment; pill; primary health care; primary prevention; priority journal; randomized controlled trial; secondary prevention; sudden death; unstable angina pectoris
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 10 Sep 2016 08:57
Last Modified: 10 Sep 2016 08:57
URI: http://eprints.goums.ac.ir/id/eprint/4814

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