Misato Chimura, Xiaowen Wang, Pardeep S Jhund, Alasdair D Henderson, Brian L Claggett, Akshay S Desai, Cândida Fonseca, Eva Goncalvesova, Tzvetana Katova, Katharina Mueller, Andrea Glasauer, Katja Rohwedder, Prabhakar Viswanathan, Savina Nodari, Carolyn S P Lam, Clara Inés Saldarriaga, Michele Senni, Kavita Sharma, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Orly Vardeny, Muthiah Vaduganathan, Scott D Solomon, John J V McMurray
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However, little is known about the safety and efficacy of treatment with finerenone according to sex.</p><p><strong>Objective: </strong>To estimate the efficacy and safety of finerenone compared with placebo in both women and men.</p><p><strong>Design, setting, and participants: </strong>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). 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.</p><p><strong>Intervention: </strong>Finerenone (titrated to 20 mg or 40 mg) or placebo.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits).</p><p><strong>Results: </strong>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. 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Finerenone had similar tolerability in women and men.</p><p><strong>Conclusions and relevance: </strong>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. 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引用次数: 0
摘要
重要性：性别与心力衰竭（HF）患者的临床表现、预后和对治疗的反应有关。然而，人们对根据性别使用非格列酮治疗的安全性和有效性知之甚少：目的：评估非格列酮与安慰剂相比对女性和男性的疗效和安全性：在心力衰竭患者非奈酮疗效和安全性优于安慰剂的3期随机临床试验（FINEARTS-HF）中进行了预设分析。该试验在 37 个国家的 653 个地点进行。参与者为年龄在40岁及以上、患有症状性心力衰竭且左心室射血分数（LVEF）大于或等于40%的成年人，在2020年9月至2023年1月期间进行随机分组：非格列酮（滴定至 20 毫克或 40 毫克）或安慰剂：主要结果和测量指标：主要结果是心血管死亡和全部（首次和复发）HF事件（非计划性HF住院或紧急HF就诊）的复合结果：FINEARTS-HF共有6001名患者接受了随机治疗，其中2732人为女性（45.5%），平均（标清）年龄为73.6（9.1）岁。女性肥胖率较高，LVEF（54.6 [7.6%] vs 50.9 [7.6]）较高，估计肾小球滤过率的平均值（标度）低于男性（59.7 [19.1] vs 64.1 [20.0]；结论与意义：在FINEARTS-HF中，非格列酮能降低射血分数轻度降低或保留的女性和男性心力衰竭患者的主要终点风险。非格列酮对女性和男性的耐受性相似：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT04435626。
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.
Importance: Sex 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.
Objective: To estimate the efficacy and safety of finerenone compared with placebo in both women and men.
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). 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.
Intervention: Finerenone (titrated to 20 mg or 40 mg) or placebo.
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).
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. 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 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. Finerenone had similar tolerability in women and men.
JAMA cardiologyMedicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍：
JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications.
Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program.
Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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