非奈利酮改善射血分数轻度降低或保留的心力衰竭患者结局：FINEARTS-HF 的预先设定分析。
Finerenone Improves Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction Irrespective of Age: A Prespecified Analysis of FINEARTS-HF.
机构信息
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (M.C., M.C.P., A.D.H., P.S.J., J.J.V.M.).
Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark (M. Schou).
出版信息
Circ Heart Fail. 2024 Nov;17(11):e012437. doi: 10.1161/CIRCHEARTFAILURE.124.012437. Epub 2024 Sep 29.
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); =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); =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.
背景
非奈利酮可改善射血分数轻度降低或保留的心力衰竭患者的预后。了解非奈利酮在这些患者中的疗效和安全性，根据年龄分层非常重要。
方法
本分析旨在评估年龄与 finerenone 在 FINEARTS-HF 试验（非奈利酮临床试验，以评估在心力衰竭患者中与安慰剂相比的疗效和安全性）中的疗效和安全性之间的交互作用。6001 例年龄 40 至 97 岁的患者按基线年龄四分位（Q1-Q4）分层：Q1，40 至 66 岁（n=1581）；Q2，67 至 73 岁（n=1587）；Q3，74 至 79 岁（n=1421）；Q4，≥80 岁（n=1412）。FINEARTS-HF 评估了年龄对非奈利酮疗效的影响，主要复合终点为心血管死亡和总（首次和复发）心力衰竭事件，包括心力衰竭住院或紧急心力衰竭事件，以及次要疗效和安全性终点。
结果
主要结局的发生率随年龄增加而增加。非奈利酮在所有年龄组中一致降低主要结局风险：Q1 比值比为 0.70（95%CI，0.53-0.92）；Q2 为 0.83（95%CI，0.64-1.07）；Q3 为 0.98（95%CI，0.76-1.26）；Q4 为 0.85（95%CI，0.67-1.07）；=0.27。同样，主要结局的各个组成部分也观察到一致的效果。与安慰剂相比，非奈利酮治疗 12 个月时堪萨斯城心肌病问卷总症状评分的平均增加更大，在所有年龄组中均具有一致的效果：Q1 的平均安慰剂校正变化为 2.87（95%CI，1.09-4.66）；Q2 为 1.24（95%CI，-0.59 至 3.07）；Q3 为 0.94（-0.98 至 2.86）；Q4 为 1.24（-0.90 至 3.38）；=0.50。所有年龄组的不良事件相似。与非奈利酮相关的低血压、肌酐升高或高钾血症（增加）或低钾血症（降低）的发生几率与年龄无关。
结论
在 FINEARTS-HF 试验中，非奈利酮降低了主要结局和主要结局的组成部分，并改善了广泛年龄范围内的症状。此外，非奈利酮安全且耐受良好，与年龄无关。
登记
网址：https://www.clinicaltrials.gov；唯一标识符：NCT04435626 和 EudraCT 2020-000306-29。
Zotero 插件