当前位置： SCI文献检索 > European Journal of Preventive Cardiology期刊下所有文献 > Polypill for the prevention of cardiovascular disease (PolyIran): study design and rationale for a pragmatic cluster randomized controlled trial.

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

Abstract：

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.

journal_name

Eur J Prev Cardiol

journal_title

European journal of preventive cardiology

authors

Ostovaneh MR,Poustchi H,Hemming K,Marjani H,Pourshams A,Nateghi A,Majed M,Navabakhsh B,Khoshnia M,Jaafari E,Mohammadifard N,Malekzadeh F,Merat S,Sadeghi M,Naemi M,Etemadi A,Thomas GN,Sarrafzadegan N,Cheng KK,Marshal

doi

10.1177/2047487314550803

subject

Has Abstract

pub_date

2015-12-01 00:00:00

pages

1609-17

issue

eissn

2047-4873

issn

2047-4881

pii

2047487314550803

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

在线工具

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