Effects of beta-blockers on quality of life and well-being in patients with myocardial infarction and preserved left ventricular function-a prespecified substudy from REDUCE-AMI.

IF 5.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS European Heart Journal - Cardiovascular Pharmacotherapy Pub Date : 2024-09-01 DOI:10.1093/ehjcvp/pvae062

Katarina Mars, Sophia Humphries, Philip Leissner, Martin Jonsson, Patric Karlström, Jörg Lauermann, Joakim Alfredsson, Thomas Kellerth, Annica Ravn-Fischer, David Erlinge, Bertil Lindahl, Troels Yndigegn, Tomas Jernberg, Claes Held, Erik M G Olsson, Robin Hofmann

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Abstract

Aims: In the Randomized Evaluation of Decreased Usage of Beta-Blockers after Acute Myocardial Infarction (REDUCE-AMI) study, long-term beta-blocker use in patients after acute myocardial infarction (AMI) with preserved left ventricular ejection fraction demonstrated no effect on death or cardiovascular outcomes. The aim of this prespecified substudy was to investigate effects of beta-blockers on self-reported quality of life and well-being.

Methods and results: From this parallel-group, open-label, registry-based randomized clinical trial, EQ-5D, and World Health Organization well-being index-5 (WHO-5) questionnaires were obtained at 6-10 weeks and 11-13 months after AMI in 4080 and 806 patients, respectively. We report results from intention-to-treat and on-treatment analyses for the overall population and relevant subgroups using Wilcoxon rank sum test and adjusted ordinal regression analyses. Of the 4080 individuals reporting EQ-5D (median age 64 years, 22% female), 2023 were randomized to beta-blockers. The main outcome, median EQ-5D index score, was 0.94 [interquartile range (IQR) 0.88, 0.97] in the beta-blocker group, and 0.94 (IQR 0.88, 0.97) in the no-beta-blocker group 6-10 weeks after AMI, OR 1.00 [95% CI 0.89-1.13; P > 0.9]. After 11-13 months, results remained unchanged. Findings were robust in on-treatment analyses and across relevant subgroups. Secondary outcomes, EQ-VAS and WHO-5 index score, confirmed these results.

Conclusion: Among patients after AMI with preserved left ventricular ejection fraction, self-reported quality of life and well-being was not significantly different in individuals randomized to routine long-term beta-blocker therapy as compared to individuals with no beta-blocker use. These results appear consistent regardless of adherence to randomized treatment and across subgroups which emphasizes the need for a careful individual risk-benefit evaluation prior to initiation of beta-blocker treatment.

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β-受体阻滞剂对心肌梗死和左心室功能保留患者生活质量和幸福感的影响--REDUCE-AMI 的一项预设子研究。

目的：在急性心肌梗死后减少使用β-受体阻滞剂的随机评估（REDUCE-AMI）研究中，左心室射血分数保留的急性心肌梗死（AMI）患者长期使用β-受体阻滞剂对死亡或心血管预后没有影响。这项预先指定的子研究旨在调查β-受体阻滞剂对自我报告的生活质量和幸福感的影响：在这项平行分组、开放标签、基于登记的随机临床试验中，分别对 4080 名和 806 名急性心肌梗死患者在术后 6-10 周和 11-13 个月进行了 EQ-5D 和世界卫生组织幸福指数-5（WHO-5）问卷调查。我们采用 Wilcoxon 秩和检验和调整后的序数回归分析，报告了总体人群和相关亚群的意向治疗分析和治疗分析结果。在报告 EQ-5D 的 4080 名患者（中位年龄为 64 岁，22% 为女性）中，有 2023 人随机接受了β-受体阻滞剂治疗。主要结果，即急性心肌梗死后 6-10 周，β-受体阻滞剂组的 EQ-5D 指数得分中位数为 0.94 [四分位数间距 (IQR) 0.88, 0.97]，无β-受体阻滞剂组为 0.94 (IQR 0.88, 0.97)，OR 1.00 [95% CI 0.89-1.13; P > 0.9]。11-13 个月后，结果保持不变。在治疗分析和相关亚组中，结果都很可靠。次要结果、EQ-VAS和WHO-5指数评分证实了这些结果：结论：在左心室射血分数保留的急性心肌梗死患者中，随机接受常规长期β-受体阻滞剂治疗的患者与不使用β-受体阻滞剂的患者相比，自我报告的生活质量和幸福感没有显著差异。无论是否坚持随机治疗以及在不同的亚组中，这些结果似乎都是一致的，这就强调了在开始β-受体阻滞剂治疗之前，需要对个体进行仔细的风险-效益评估。

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来源期刊

European Heart Journal - Cardiovascular Pharmacotherapy Medicine-Cardiology and Cardiovascular Medicine

CiteScore

10.10

自引率

14.10%

发文量

期刊介绍： The European Heart Journal - Cardiovascular Pharmacotherapy (EHJ-CVP) is an international, peer-reviewed journal published in English, specifically dedicated to clinical cardiovascular pharmacology. EHJ-CVP publishes original articles focusing on clinical research involving both new and established drugs and methods, along with meta-analyses and topical reviews. The journal's primary aim is to enhance the pharmacological treatment of patients with cardiovascular disease by interpreting and integrating new scientific developments in this field. While the emphasis is on clinical topics, EHJ-CVP also considers basic research articles from fields such as physiology and molecular biology that contribute to the understanding of cardiovascular drug therapy. These may include articles related to new drug development and evaluation, the physiological and pharmacological basis of drug action, metabolism, drug interactions, and side effects.