Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial.

However, little is known about the safety and efficacy of treatment with finerenone according to sex.

然而，关于根据性别使用非奈利酮治疗的安全性和有效性知之甚少。

Background

To estimate the efficacy and safety of finerenone compared with placebo in both women and men.

评估非奈利酮与安慰剂在女性和男性中的疗效和安全性。

DESIGN, SETTING, AND PARTICIPANTS: Prespecified analyses were conducted in the phase 3 randomized clinical trial Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF).

设计、环境和参与者：在第三阶段的随机临床试验Finerenone试验中进行了预先规定的分析，该试验旨在研究非奈利酮在心力衰竭患者中相对于安慰剂的疗效和安全性优越性（FINEARTS-HF）。

The trial was conducted across 653 sites in 37 countries.

该试验在37个国家的653个地点进行。

Participants were adults aged 40 years and older with symptomatic HF and left ventricular ejection fraction (LVEF) of 40% or greater randomized between September 2020 and January 2023.

参与者为40岁及以上的成年患者，这些患者有症状性心力衰竭和左心室射血分数（LVEF）为40%或更高，他们在2020年9月至2023年1月之间被随机分配。

intervention

Finerenone (titrated to 20 mg or 40 mg) or placebo.

非奈利酮（逐渐增加剂量至20毫克或40毫克）或安慰剂。

main_outcomes_and_measures

The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits).

主要结果是心血管死亡和总心力衰竭事件（计划外心力衰竭住院或紧急心力衰竭就诊）的复合结果。

Results

A total of 6001 patients were randomized in FINEARTS-HF, of whom 2732 were women (45.5%), with a mean (SD) age of 73.6 (9.1) years.

在FINEARTS-HF研究中，共有6001名患者被随机分配，其中2732名为女性（占45.5%），平均（标准差）年龄为73.6（9.1）岁。

Women had higher rates of any obesity, higher LVEF (54.6 [7.6%] vs 50.9 [7.6] for men), lower mean (SD) estimated glomerular filtration rate than men (59.7 [19.1] vs 64.1 [20.0] for men; P<.001) , worse New York Heart Association functional class, and lower Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) (mean [SD] 62.3 [24.0] vs 71.0 [23.1]).

女性患者中，任何肥胖的发生率更高，左心室射血分数（LVEF）更高（女性为54.6 [7.6%]，男性为50.9 [7.6]），估算的肾小球滤过率低于男性（女性为59.7 [19.1]，男性为64.1 [20.0]；P<.001），纽约心脏协会功能分级更差，堪萨斯城心肌病问卷-总症状评分（KCCQ-TSS）更低（女性平均值[标准差]为62.3 [24.0]，男性为71.0 [23.1]）。

The incident rate of the primary outcome was slightly lower in women (15.7; 95% CI, 14.3-17.3) than in men (16.8; 95% CI, 15.4-18.3) per 100 person-years.

主要结果的发生率在女性中略低于男性（女性为15.7；95%置信区间，14.3-17.3；男性为16.8；95%置信区间，15.4-18.3）每100人年。

Compared with placebo, finerenone reduced the risk of the primary end point similarly in women and men: rate ratio 0.78 (95% CI, 0.65-0.95) in women and 0.88 (95% CI, 0.74-1.04) in men (P = .41 for interaction).

与安慰剂相比，非奈利酮在女性和男性中同样降低了主要终点的风险：女性的率比为0.78（95%置信区间，0.65-0.95），男性的率为0.88（95%置信区间，0.74-1.04）（交互作用P = .41）。

Consistent effects were observed for the components of the primary outcome and all-cause mortality.

观察到主要结果组成部分和全因死亡率的一致效应。

The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex (P = .73 for interaction).

从基线到12个月，无论性别如何，与安慰剂相比，使用非奈利酮治疗的患者KCCQ-TSS的平均增加（改善）更大（交互作用P = .73）。

Finerenone had similar tolerability in women and men.

Finerenone在女性和男性中具有相似的耐受性。

conclusions_and_relevance

In FINEARTS-HF, finerenone reduced the risk of the primary end point similarly in women and men with heart failure with mildly reduced or preserved ejection fraction.

在FINEARTS-HF研究中，Finerenone在射血分数轻度降低或保留的心力衰竭女性和男性中，降低了主要终点事件的风险，效果相似。

Finerenone had similar tolerability in women and men.

Finerenone在女性和男性中具有相似的耐受性。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

ClinicalTrials.gov注册号：NCT04435626。