More women than men have heart failure with preserved ejection fraction (HFpEF). The purpose of this study was to assess baseline characteristics and treatment effect of semaglutide by sex across the STEP-HFpEF (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity) program. In a prespecified secondary analysis of pooled data from STEP-HFpEF and STEP-HFpEF DM (Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes), patients with heart failure (HF), left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m, and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to once-weekly semaglutide 2.4 mg or matched placebo for 52 weeks. Dual primary endpoints (KCCQ-CSS change and percentage change in body weight) and confirmatory secondary endpoints (6-minute walking distance [6MWD] change; hierarchical composite endpoint comprising all-cause death, HF events, changes in KCCQ-CSS, and 6MWD; and C-reactive protein) were compared between sexes. Of 1,145 patients, 570 (49.7%) were women. Women had higher body mass index, left ventricular ejection fraction, C-reactive protein, and worse HF symptoms, and were less likely to have atrial fibrillation or coronary artery disease vs men. Semaglutide improved KCCQ-CSS regardless of sex (mean difference in women +7.6 points [95% CI: 4.5-10.7 points]; men +7.5 points [95% CI: 4.3-10.6 points]; interaction = 0.94) but reduced body weight more in women (mean difference in women −9.6% [95% CI: −10.9% to −8.4%]; men −7.2% [95% CI: −8.4% to −6.0%]; interaction = 0.006). Semaglutide improved 6MWD ( interaction = 0.21) and the hierarchical composite endpoint ( interaction = 0.66) in both sexes. Fewer serious adverse events were reported with semaglutide vs placebo. In patients with obesity-related HFpEF, semaglutide 2.4 mg reduced body weight to a greater extent in women, and produced similar improvements in HF-related symptoms, physical limitations, and exercise function, regardless of sex. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF]; ; and Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes [STEP HFpEF DM]; )

中文翻译：

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索马鲁肽对射血分数保留的肥胖相关性心力衰竭的不同性别疗效：STEP-HFpEF 试验


患有射血分数保留型心力衰竭 (HFpEF) 的女性多于男性。本研究的目的是评估 STEP-HFpEF（调查索马鲁肽对心力衰竭和肥胖患者的疗效的研究）计划中按性别划分的基线特征和治疗效果。在对 STEP-HFpEF 和 STEP-HFpEF DM（研究索马鲁肽对心力衰竭、肥胖和 2 型糖尿病患者的疗效的研究）的汇总数据进行预先指定的二次分析时，心力衰竭 (HF) 患者左心室射血分数≥45%、体重指数≥30 kg/m、堪萨斯城心肌病问卷临床总结评分 (KCCQ-CSS) <90 分按 1:1 随机分配至每周一次索马鲁肽 2.4 mg 或匹配安慰剂，持续 52 周。双重主要终点（KCCQ-CSS 变化和体重百分比变化）和确认性次要终点（6 分钟步行距离 [6MWD] 变化；分层复合终点包括全因死亡、心力衰竭事件、KCCQ-CSS 变化和 6MWD ; 和 C 反应蛋白）在性别之间进行比较。在 1,145 名患者中，570 名 (49.7%) 是女性。与男性相比，女性的体重指数、左心室射血分数、C 反应蛋白更高，心力衰竭症状更严重，并且患房颤或冠状动脉疾病的可能性更小。无论性别如何，索马鲁肽均可改善 KCCQ-CSS（女性平均差异 +7.6 分 [95% CI: 4.5-10.7 分]；男性 +7.5 分 [95% CI: 4.3-10.6 分]；交互作用 = 0.94），但体重减轻女性更多（女性平均差异−9.6% [95% CI: −10.9% to −8.4%]；男性−7.2% [95% CI: −8.4% to −6.0%]；交互作用= 0.006）。索马鲁肽改善了 6MWD（相互作用 = 0.21）和分层复合终点（相互作用 = 0.66) 男女皆宜。与安慰剂相比，索马鲁肽报告的严重不良事件较少。在患有肥胖相关 HFpEF 的患者中，无论性别如何，索马鲁肽 2.4 mg 都能更大程度地减轻女性体重，并且对 HF 相关症状、身体限制和运动功能产生类似的改善。（调查索马鲁肽对心力衰竭和肥胖患者的疗效的研究 [STEP-HFpEF]；以及了解索马鲁肽对心力衰竭、肥胖和 2 型糖尿病患者的疗效的研究 [STEP HFpEF DM] ];