Department of Epidemiology and Biostatistics, University of Auckland, Auckland, New Zealand.
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Heart. 2019 Jan;105(1):42-48. doi: 10.1136/heartjnl-2018-313108. Epub 2018 Jun 28.
The aim of this study was to determine the effect of polypill-based care on the achievement of 2016 European Society of Cardiology (ESC) guideline targets for blood pressure (BP), low-density lipoprotein (LDL) cholesterol and antiplatelet therapy.
We conducted an individual participant data meta-analysis of three randomised clinical trials that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior cardiovascular disease (CVD) event or who were at high risk of their first event. Overall, the trials included 3140 patients from Australia, England, India, Ireland, the Netherlands and New Zealand (75% male, mean age 62 years and 76% with a prior CVD event). The primary outcome for this study was the proportion of people achieving ESC guideline targets for BP, LDL and antiplatelet therapy.
Those randomised to polypill-based care were more likely than those receiving usual care to achieve recommended targets for BP (62% vs 58%, risk ratio (RR) 1.08, 95% CI 1.02 to 1.15), LDL (39% vs 34%, RR 1.13, 95% CI 1.02 to 1.25) and all three targets for BP, LDL and adherence to antiplatelet therapy (the latter only applicable to those with a prior CVD event) simultaneously (24% vs 19%, RR 1.27, 95% CI 1.10 to 1.47) at 12 months. There was no difference between groups in antiplatelet adherence (96% vs 96%, RR 1.00, 95% CI 0.98 to 1.01). There was heterogeneity by baseline treatment intensity such that treatment effects increased with the fewer the number of treatments being taken at baseline: for patients taking 3, 2 and 0-1 treatment modalities the RRs for reaching all three guideline goals simultaneously were 1.10 (95% CI 0.94 to 1.30, 22% vs 20%), 1.62 (95% CI 1.09 to 2.42, 27% vs 17%) and 3.07 (95% CI 1.77 to 5.33, 35% vs 11%), respectively.
Polypill-based therapy significantly improved the achievement of all three ESC targets for BP, LDL and antiplatelet therapy compared with usual care, particularly among those undertreated at baseline.
本研究旨在确定基于复方药的治疗方案对 2016 年欧洲心脏病学会（ESC）血压（BP）、低密度脂蛋白（LDL）胆固醇和抗血小板治疗指南目标的影响。
我们对三项随机临床试验的个体参与者数据进行了荟萃分析，这些试验比较了使用包含阿司匹林、他汀类药物和降压治疗的复方药与常规治疗在既往心血管疾病（CVD）事件患者或首次发生 CVD 事件风险较高的患者中的效果。总体而言，这些试验包括来自澳大利亚、英国、印度、爱尔兰、荷兰和新西兰的 3140 名患者（75%为男性，平均年龄 62 岁，76%有既往 CVD 事件）。本研究的主要结局是达到 ESC 指南对 BP、LDL 和抗血小板治疗的建议目标的患者比例。
与接受常规治疗的患者相比，接受复方药治疗的患者更有可能达到 BP（62%比 58%，风险比[RR] 1.08，95%置信区间[CI] 1.02 至 1.15）、LDL（39%比 34%，RR 1.13，95% CI 1.02 至 1.25）和 BP、LDL 以及抗血小板治疗同时达到所有三个目标（仅适用于有既往 CVD 事件的患者）的推荐目标（24%比 19%，RR 1.27，95% CI 1.10 至 1.47）的可能性更高。两组之间在抗血小板药物的依从性方面没有差异（96%比 96%，RR 1.00，95% CI 0.98 至 1.01）。根据基线治疗强度存在异质性，治疗效果随基线治疗方法数量的减少而增加：对于服用 3、2 和 0-1 种治疗方式的患者，同时达到所有三个指南目标的 RR 分别为 1.10（95% CI 0.94 至 1.30，22%比 20%）、1.62（95% CI 1.09 至 2.42，27%比 17%）和 3.07（95% CI 1.77 至 5.33，35%比 11%）。
与常规治疗相比，基于复方药的治疗方案显著提高了 BP、LDL 和抗血小板治疗的所有三个 ESC 目标的达标率，尤其是在基线治疗不足的患者中。
