Finerenone Improves Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction Irrespective of Age: A Prespecified Analysis of FINEARTS-HF.

IF 7.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Circulation: Heart Failure Pub Date : 2024-11-01 Epub Date: 2024-09-29 DOI:10.1161/CIRCHEARTFAILURE.124.012437
Misato Chimura, Mark C Petrie, Morten Schou, Felipe A Martinez, Alasdair D Henderson, Brian L Claggett, Akshay S Desai, Peter Kolkhof, Prabhakar Viswanathan, Andrea Lage, Carolyn S P Lam, Michele Senni, Sanjiv J Shah, Katja Rohwedder, Katharina Mueller, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Muthiah Vaduganathan, Pardeep S Jhund, Scott D Solomon, John J V McMurray
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引用次数: 0

Abstract

Background: Finerenone improves outcomes in patients with heart failure and mildly reduced or preserved ejection fraction. It is important to understand the efficacy and safety of finerenone in these patients according to age.

Methods: The aim of this analysis was to evaluate the interaction between age and the efficacy and safety of finerenone in the FINEARTS-HF trial (Finerenone Trial to Investigate Efficacy and Safety Compared to Placebo in Patients With Heart Failure). A total of 6001 patients aged 40 to 97 years were stratified by quartile (Q1-Q4) of baseline age: Q1, 40 to 66 years (n=1581); Q2, 67 to 73 years (n=1587); Q3, 74 to 79 years (n=1421); and Q4, ≥80 years (n=1412). FINEARTS-HF evaluated the impact of age on the efficacy of finerenone with respect to the primary composite outcome of cardiovascular death and total (first and recurrent) heart failure events, including heart failure hospitalization or urgent heart failure event, along with secondary efficacy and safety outcomes.

Results: The incidence of primary outcomes increased with age. Finerenone reduced the risk of the primary outcome consistently across all age categories: rate ratio in Q1, 0.70 (95% CI, 0.53-0.92); Q2, 0.83 (95% CI, 0.64-1.07); Q3, 0.98 (95% CI, 0.76-1.26); and Q4, 0.85 (95% CI, 0.67-1.07); Pinteraction=0.27. Similarly, a consistent effect was observed for the components of the primary outcome. The mean increase in Kansas City Cardiomyopathy Questionnaire-total symptom score from baseline to 12 months was greater with finerenone than placebo, with a consistent effect across all age categories: mean placebo-corrected change in Q1, 2.87 (95% CI, 1.09-4.66); Q2, 1.24 (95% CI, -0.59 to 3.07); Q3, 0.94 (-0.98 to 2.86); and Q4, 1.24 (-0.90 to 3.38); Pinteraction=0.50. Adverse events were similar across all age categories. The odds of experiencing hypotension, elevated creatinine, or hyperkalemia (increased) or hypokalemia (decreased) related to finerenone did not differ by age.

Conclusions: In the FINEARTS-HF trial, finerenone reduced the primary outcome and components of the primary outcome and improved symptoms across a wide age spectrum. In addition, finerenone was safe and well-tolerated, irrespective of age.

Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT04435626 and EudraCT 2020-000306-29.

非格列酮能改善射血分数轻度降低或保留的心衰患者的预后,与年龄无关:FINEARTS-HF的预设分析。
背景:非格列酮能改善心房颤动和射血分数轻度降低或保留(HFmrHF/HFpEF)患者的预后。了解非格列酮对不同年龄患者的疗效和安全性非常重要。方法:本分析的目的是评估 FINEARTS-HF 试验(与安慰剂相比,研究心衰患者非格列酮疗效和安全性的非格列酮试验)中年龄与非格列酮疗效和安全性之间的相互作用。共有 6,001 名 40-97 岁的患者按基线年龄的四分位数(Q 1-4)进行了分层:Q1 40-66 岁(1,581 人),Q2 67-73 岁(1,587 人),Q3 74-79 岁(1,421 人),Q4 ≧ 80 岁(1,412 人)。FINEARTS-HF评估了年龄对非那瑞酮疗效的影响,包括心血管死亡和全部(首次和复发)HF事件(包括HF住院或紧急HF事件)等主要复合结局,以及次要疗效和安全性结局。结果显示主要结局的发生率随年龄增长而增加。非格列酮能持续降低所有年龄组的主要结局风险:RR (95% CI) Q1 0.70 (0.53-0.92),Q2 0.83 (0.64-1.07),Q3 0.98 (0.76-1.26),Q4 0.85 (0.67-1.07);交互作用 p =0.27。同样,在主要结果的各组成部分中也观察到了一致的效果。与安慰剂相比,非格列酮能使堪萨斯城心肌病问卷-症状总分从基线到12个月的平均增加幅度更大,且对所有年龄组的影响一致:安慰剂校正后的平均变化(95% CI)Q1为2.87(1.09-4.66),Q2为1.24(-0.59-3.07),Q3为0.94(-0.98-2.86),Q4为1.24(-0.90-3.38);交互作用的P=0.50。所有年龄组的不良事件发生率相似。与非诺利酮有关的低血压、肌酐升高、高钾血症(增加)或低钾血症(减少)的发生几率并不因年龄而异。结论在FINEARTS-HF试验中,非奈酮降低了主要结果和主要结果的组成部分,并改善了不同年龄段的症状。此外,非奈酮安全且耐受性良好,与年龄无关。试验注册:URL: https://clinicaltrials.gov 唯一标识符:NCT04435626和EudraCT 2020-000306-29。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Circulation: Heart Failure
Circulation: Heart Failure 医学-心血管系统
CiteScore
12.90
自引率
3.10%
发文量
271
审稿时长
6-12 weeks
期刊介绍: Circulation: Heart Failure focuses on content related to heart failure, mechanical circulatory support, and heart transplant science and medicine. It considers studies conducted in humans or analyses of human data, as well as preclinical studies with direct clinical correlation or relevance. While primarily a clinical journal, it may publish novel basic and preclinical studies that significantly advance the field of heart failure.
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