TY - JOUR
T1 - Polypill for the prevention of cardiovascular disease (PolyIran)
T2 - study design and rationale for a pragmatic cluster randomized controlled trial
AU - Ostovaneh, Mohammad Reza
AU - Poustchi, Hossein
AU - Hemming, Karla
AU - Marjani, Hajiamin
AU - Pourshams, Akram
AU - Nateghi, Alireza
AU - Majed, Masoud
AU - Navabakhsh, Behrouz
AU - Khoshnia, Masoud
AU - Jaafari, Elham
AU - Mohammadifard, Noushin
AU - Malekzadeh, Fatemeh
AU - Merat, Shahin
AU - Sadeghi, Masoumeh
AU - Naemi, Mohammad
AU - Etemadi, Arash
AU - Thomas, Neil
AU - Sarrafzadegan, Nizal
AU - Cheng, KK
AU - Marshall, Tom
AU - Malekzadeh, Reza
N1 - © The European Society of Cardiology 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
PY - 2015/12
Y1 - 2015/12
N2 - 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.
AB - 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.
U2 - 10.1177/2047487314550803
DO - 10.1177/2047487314550803
M3 - Article
C2 - 25230980
SN - 2047-4873
VL - 22
SP - 1609
EP - 1617
JO - European journal of preventive cardiology
JF - European journal of preventive cardiology
IS - 12
ER -