BACKGROUND Steroidal mineralocorticoid receptor antagonists reduce morbidity and mortality among patients with heart failure and reduced ejection fraction, but their efficacy in those with heart failure and mildly reduced or preserved ejection fraction has not been established. Data regarding the efficacy and safety of the nonsteroidal mineralocorticoid receptor antagonist finerenone in patients with heart failure and mildly reduced or preserved ejection fraction are needed. METHODS In this international, double-blind trial, we randomly assigned patients with heart failure and a left ventricular ejection fraction of 40% or greater, in a 1:1 ratio, to receive finerenone (at a maximum dose of 20 mg or 40 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of total worsening heart failure events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes. The components of the primary outcome and safety were also assessed. RESULTS Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients in the finerenone group, and 1283 primary-outcome events occurred in 719 of 2998 patients in the placebo group (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007). The total number of worsening heart failure events was 842 in the finerenone group and 1024 in the placebo group (rate ratio, 0.82; 95% CI, 0.71 to 0.94; P = 0.006). The percentage of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). Finerenone was associated with an increased risk of hyperkalemia and a reduced risk of hypokalemia. CONCLUSIONS In patients with heart failure and mildly reduced or preserved ejection fraction, finerenone resulted in a significantly lower rate of a composite of total worsening heart failure events and death from cardiovascular causes than placebo. (Funded by Bayer; FINEARTS-HF ClinicalTrials.gov number, NCT04435626.).

中文翻译：

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Finerenone 治疗射血分数轻度降低或保留的心力衰竭。


背景 甾体盐皮质激素受体拮抗剂可降低心力衰竭和射血分数降低患者的发病率和死亡率，但其对射血分数轻度降低或保留的心力衰竭患者的疗效尚未确定。需要有关非甾体盐皮质激素受体拮抗剂 finerenone 在射血分数轻度降低或保留的心力衰竭患者中的疗效和安全性的数据。方法 在这项国际双盲试验中，我们以 1：1 的比例随机分配左心室射血分数为 40% 或更高的心力衰竭患者接受非利酮（最大剂量为 20 毫克或 40 毫克，每天一次）或匹配的安慰剂，除了常规治疗。主要结局是总心力衰竭恶化事件 （事件定义为首次或复发性意外住院或因心力衰竭紧急就诊） 和心血管原因死亡的复合结果。还评估了主要结局和安全性的组成部分。结果 在中位 32 个月的随访中，finerenone 组 3003 例患者中有 624 例发生了 1083 例主要结局事件，安慰剂组 2998 例患者中有 719 例发生了 1283 例主要结局事件（比率比，0.84;95% 置信区间 [CI]，0.74 至 0.95;P = 0.007）。非奈利酮组恶化的心力衰竭事件总数为 842 例，安慰剂组为 1024 例 （比率比，0.82;95% CI，0.71 至 0.94;P = 0.006）。死于心血管原因的患者百分比分别为 8.1% 和 8.7% （风险比，0.93;95% CI，0.78 至 1.11）。Finerenone 与高钾血症风险增加和低钾血症风险降低相关。 结论 在射血分数轻度降低或保留的心力衰竭患者中，与安慰剂相比，finerenone 导致心力衰竭事件总恶化和心血管原因死亡的复合发生率显着降低。（由拜耳资助;FINEARTS-HF ClinicalTrials.gov 编号，NCT04435626.）。