本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2313917

摘要内容如下：

背景

肥胖和2型糖尿病在射血分数正常的心力衰竭患者中普遍存在，并以高症状负担为特征。没有批准的治疗方法专门针对2型糖尿病患者射血分数维持的肥胖相关心力衰竭。

方法

我们将射血分数维持、体重指数（体重（公斤）除以身高（米）的平方）等于或大于30且患有2型糖尿病的心力衰竭患者随机分为两组，一组接受每周一次的semaglutide（2.4 mg）治疗，另一组接受安慰剂治疗，为期52周。主要终点是堪萨斯城心肌病问卷临床总结评分（KCCQ-CSS；评分范围从0到100，评分越高表明症状和身体限制越少）相对于基线的变化和体重的变化。验证性次要终点包括6分钟步行距离的变化；分层复合终点包括死亡、心力衰竭事件以及KCCQ-CSS和6分钟步行距离变化的差异；以及C-反应蛋白（CRP）水平的变化。

结果

共有616名参与者接受了随机分组。Semaglutide的KCCQ-CSS平均变化为13.7分，安慰剂为6.4分（估计差异为7.3分；95%置信区间[CI]，4.1至10.4；P<0.001），Semaglutide组的平均体重变化百分比为-9.8%，安慰剂组为-3.4%（估计差异为-6.4个百分点；95%可信区间为-7.6~-5.2；P<0.001）。与安慰剂相比，验证性次要终点的结果更有利于semaglutide（6分钟步行距离变化的估计组间差异，14.3米[95%CI，3.7至24.9；P=0.008]；分级复合终点的赢率，1.58[95%CI，1.29至1.94；P<0.001]；CRP水平变化的估计治疗比为0.67[95%CI，0.55-0.80；P<0.001]）。Semaglutide组和安慰剂组分别有55例（17.7%）和88例（28.8%）受试者报告了严重不良事件。

结论

在射血分数维持的肥胖相关心力衰竭和2型糖尿病患者中，与安慰剂相比，Semaglutide在1年内可更大程度地减轻心力衰竭相关症状和身体限制，并减轻更多体重。（由诺和诺德公司资助；STEP-HFPEF DM ClinicalTrials.gov编号，NCT04916470。）

英文原文如下：

Abstracts

BACKGROUND  Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes.

METHODS  We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level.

RESULTS  A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group.

CONCLUSIONS  Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. (Funded by Novo Nordisk; STEP-HFpEF DM ClinicalTrials.gov number, NCT04916470.).

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