多效丸对心血管疾病一级和二级预防的效果:一项实用分组随机对照试验(PolyPars)。

IF 5.1 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Heart Pub Date : 2024-06-25 DOI:10.1136/heartjnl-2023-323614
Fatemeh Malekzadeh, Abdullah Gandomkar, Hossein Poustchi, Arash Etemadi, Gholamreza Roshandel, Armin Attar, Firoozeh Abtahi, Shahrokh Sadeghi Boogar, Vahid Mohammadkarimi, Mohammad Reza Fattahi, Abbas Mohagheghi, Reza Malekzadeh, Sadaf G Sepanlou
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引用次数: 0

摘要

背景:我们旨在调查固定剂量联合疗法(多药联用)在典型的农村地区用于主要心血管疾病一级和二级预防的有效性:我们的目的是在典型的农村环境中调查固定剂量联合疗法(多丸)对主要心血管疾病一级和二级预防的有效性:PolyPars研究是一项双臂实用分组随机试验,嵌套于PARS队列研究中,包括伊朗南部整个地区所有50岁以上的居民。这 91 个村庄被随机分配到两组:对照组(包括 45 个群组)接受非药物干预(健康生活方式教育培训),而干预组(包括 46 个群组)在接受非药物干预的同时,还接受每日一次的多丸片剂。这种药片由两种降压药、他汀类药物和阿司匹林组成。主要结果是首次发生重大心血管事件,即急性冠状动脉综合征(非致命性心肌梗死和不稳定性心绞痛)、致命性心肌梗死、非致命性和致命性中风、猝死和心力衰竭住院治疗的综合结果。采用共同虚弱的 Cox 回归模型来考虑集群效应:2015年12月至2016年12月期间,共招募了4415名50-75岁的参与者(干预组2200人,对照组2215人)。总体随访时间的中位数为 4.6 年(四分位间间隔为 4.4-4.9)。干预组的多丸类药物依从率为 86%。在对照组中,2215 名参与者中有 176 人(8.0%)出现主要结果,而在多丸剂组中,2200 名参与者中有 88 人(4.0%)出现主要结果。我们发现,无论是相对值还是绝对值,主要结果的风险都大幅降低(HR 0.50,95% CI 0.38 至 0.65;绝对风险降低 4.0%,95% CI 2.5% 至 5.3%)。两组在严重不良事件方面无差异:结论:使用多潘立酮的固定剂量联合疗法可以在人群水平上安全地将主要心血管疾病的风险减半:试验注册号:NCT03459560。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars).

Background: We aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting.

Methods: The PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect.

Results: During December 2015-December 2016, a total of 4415 participants aged 50-75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4-4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups.

Conclusions: The fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level.

Trial registration number: NCT03459560.

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来源期刊
Heart
Heart 医学-心血管系统
CiteScore
10.30
自引率
5.30%
发文量
320
审稿时长
3-6 weeks
期刊介绍: Heart is an international peer reviewed journal that keeps cardiologists up to date with important research advances in cardiovascular disease. New scientific developments are highlighted in editorials and put in context with concise review articles. There is one free Editor’s Choice article in each issue, with open access options available to authors for all articles. Education in Heart articles provide a comprehensive, continuously updated, cardiology curriculum.
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