ImportanceSex is associated with the clinical presentation, outcomes, and response to treatment in patients with heart failure (HF). However, little is known about the safety and efficacy of treatment with finerenone according to sex.ObjectiveTo estimate the efficacy and safety of finerenone compared with placebo in both women and men.Design, Setting, and ParticipantsPrespecified 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). The trial was conducted across 653 sites in 37 countries. 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.InterventionFinerenone (titrated to 20 mg or 40 mg) or placebo.Main Outcomes and MeasuresThe primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits).ResultsA 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. 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]). 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. 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). Consistent effects were observed for the components of the primary outcome and all-cause mortality. The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex (P = .73 for interaction). Finerenone had similar tolerability in women and men.Conclusions and RelevanceIn 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. Finerenone had similar tolerability in women and men.Trial RegistrationClinicalTrials.gov Identifier: NCT04435626

中文翻译：

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Finerenone 用于射血分数轻度降低或保留的心力衰竭患者和男性


重要性性别与心力衰竭 （HF） 患者的临床表现、结果和对治疗的反应相关。然而，对于根据性别使用 finerenone 治疗的安全性和有效性知之甚少。目的评价非奈利酮与安慰剂相比在女性和男性中的疗效和安全性。设计、设置和参与者在 3 期随机临床试验 Finerenone 试验中进行了预先指定的分析，以研究优于安慰剂治疗心力衰竭患者的疗效和安全性 （FINEARTS-HF）。该试验在 37 个国家/地区的 653 个地点进行。参与者是 2020 年 9 月至 2023 年 1 月期间随机分配的 40 岁及以上患有症状性 HF 且左心室射血分数 （LVEF） 为 40% 或更高的成年人。主要结局和测量主要结局是心血管死亡和总 （首次和复发） HF 事件 （计划外 HF 住院或紧急 HF 就诊） 的复合。结果FINEARTS-HF 共随机纳入 6001 例患者，其中 2732 例为女性 （45.5%），平均 （SD） 年龄为 73.6 （9.1） 岁。女性的肥胖率更高，LVEF 更高（男性为 54.6 [7.6%] vs 50.9 [7.6]），平均 （SD） 估计肾小球滤过率低于男性（59.7 [19.1] vs 64.1 [20.0]）;P<。001） ，纽约心脏协会功能等级较差，堪萨斯城心肌病问卷-总症状评分 （KCCQ-TSS） 较低（平均值 [SD] 62.3 [24.0] vs 71.0 [23.1]）。女性 （15.7;95% CI， 14.3-17.3） 的主要结局发生率略低于男性 （16.8;95% CI， 15.4-18.3） 每 100 人年。 与安慰剂相比，finerenone 对女性和男性主要终点风险的降低相似：女性率比为 0.78 （95% CI，0.65-0.95），男性为 0.88 （95% CI，0.74-1.04） （交互作用 P = .41）。观察到对主要结局和全因死亡率的组成部分的一致影响。无论性别如何，finerenone 组 KCCQ-TSS 从基线到 12 个月的平均增加（改善）更大（交互作用 P = .73）。Finerenone 在女性和男性中的耐受性相似。结论和相关性在 FINEARTS-HF 中，finerenone 同样降低了射血分数轻度降低或保留的心力衰竭女性和男性发生主要终点的风险。Finerenone 在女性和男性中的耐受性相似。试验注册临床试验。gov 标识符： NCT04435626