Sex differences in pharmacological treatment of heart failure: a meta-analysis of randomized trials.

This study assesses sex differences in the primary efficacy endpoint of HF treatments and examines whether the proportion of women enrolled in a trial influences (variations in) treatment effect estimates.

本研究评估了心力衰竭(HF)治疗的主要疗效终点的性别差异，并检查了试验中女性比例对治疗效果估计的影响。

Methods

A systematic search was conducted up to 21 March 2025, including randomized controlled trials (RCTs) (≥100 patients) evaluating pharmacological HF treatments vs. placebo or usual care, with clinical events as the primary outcome.

系统检索进行至2025年3月21日，包括评估药物治疗心力衰竭与安慰剂或常规护理的随机对照试验(RCTs)（≥100名患者），以临床事件为主要结果。

Sex differences in the primary outcome were assessed using a random-effects meta-analysisof the reported relative effect measures (REM) and pooled estimates.

使用随机效应荟萃分析报告的相对效应测量(REM)和汇总估计值，评估了主要结果的性别差异。

For key clinical outcomes, meta-regression analyses were performed to examine the association between the proportion of women enrolled and sex differences in REMs, as well as the overall REMs without separating sex.

对于关键的临床结果，进行了元回归分析，以检查女性比例与性别差异的REM之间的关联，以及不区分性别的总体REM。

Results

Of 5749 screened publications, 139 RCTs met inclusion criteria, with 292 027 patients (28.1% women).

在筛选的5749篇出版物中，有139个RCT符合纳入标准，涉及292 027名患者（女性占28.1%）。

Based on 78 RCTs that reported sex-stratified treatment effects, pooled analysis showed no difference in treatment efficacy between women and men (delta ln[REM] 0.00; 95% confidence interval(CI) -0.04 to 0.03; P = .85; I2 = 4.1%).

基于78个报告性别分层治疗效果的RCTs的汇总分析显示，女性和男性之间的治疗效果没有差异（delta ln[REM] 0.00; 95%置信区间（CI）-0.04至0.03; P = .85; I2 = 4.1%）。

Meta-regression found no association between the proportion of women and sex differences in REM (78 RCTs, P = .25), overall efficacy (139 RCTs, P = .24), or other clinical outcomes.

元回归发现女性比例与REM的性别差异之间没有关联（78个RCTs, P = .25），总体疗效（139个RCTs, P = .24），或其他临床结果。

Conclusions

These findings suggest that pharmacological efficacy in HF does not differ by sex and that historical female underrepresentation in trials is unlikely to have masked important sex differences.

这些发现表明，心力衰竭的药物疗效在性别上没有差异，历史上女性在试验中的代表性不足不太可能掩盖了重要的性别差异。

Nonetheless, improving sex balance in HF trials remains essential for societal and ethical reasons.

尽管如此，出于社会和伦理原因，改善心力衰竭试验中的性别平衡仍然是至关重要的。