Yu Wanqian, Luo Fan, Rao Jingan, Lei Guangtao, Wu Qinghua, Shen Wen, Yang Pingping, Li Ping
Department of Cardiovascular Medicine, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China.
Department of Gastroenterology, Jiangxi Provincial Hospital of Traditional Chinese Medicine, Nanchang, Jiangxi, China.
Front Cardiovasc Med. 2025 May 27;12:1601552. doi: 10.3389/fcvm.2025.1601552. eCollection 2025.
Finerenone has been shown to improve outcomes in patients with heart failure (HF), encompassing those with reduced (HFrEF), mildly reduced (HFmrEF), or preserved ejection fraction (HFpEF). However, its clinical use is accompanied by notable adverse effects. This study aimed to evaluate the relative risks of adverse events associated with finerenone across HF phenotypes.
A systematic search of PubMed, Embase, and Web of Science identified six randomized controlled trials involving 8,527 HF patients. The analysis considered hyperkalemia, hypotension, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment discontinuation due to adverse events.
Finerenone significantly increased the risk of hyperkalemia (RR = 2.07, 95% CI 1.77-2.44, < 0.00001) and hypotension (RR = 1.49, 95% CI 1.31-1.68, < 0.00001) compared to placebo, irrespective of HF phenotype. No significant differences were observed between finerenone and placebo in terms of TEAEs, TESAEs, or treatment discontinuation when analyzing the overall heart failure population. Compared to eplerenone, finerenone was associated with a lower risk of TEAEs (RR = 0.93, 95% CI: 0.89-0.98) and TESAEs (RR = 0.74, 95% CI: 0.66-0.84), with similar discontinuation rates. Additionally, one included study suggested that finerenone may have a lower risk of TEAEs (RR = 0.64, 95% CI 0.56-0.74), treatment discontinuation (RR = 0.37, 95% CI 0.25-0.54) and hyperkalemia (RR = 0.41, 95% CI 0.21-0.79) compared to spironolactone, with similar rates of hypotension (RR = 0.61, 95% CI 0.29-1.30) in HFrEF.
Finerenone (10-25 mg) showed a similar safety profile to placebo, with no significant differences in TEAEs, TESAEs, or treatment discontinuation. Compared to eplerenone, finerenone was associated with fewer TEAEs and TESAEs, with comparable discontinuation rates. Moreover, in patients with HFrEF, finerenone may offer lower risks of TEAEs, treatment discontinuation, and hyperkalemia than spironolactone, with similar rates of hypotension.
非奈利酮已被证明可改善心力衰竭（HF）患者的预后，包括射血分数降低（HFrEF）、轻度降低（HFmrEF）或保留射血分数（HFpEF）的患者。然而，其临床应用伴随着显著的不良反应。本研究旨在评估非奈利酮在不同HF表型中与不良事件相关的相对风险。
对PubMed、Embase和Web of Science进行系统检索，确定了六项涉及8527例HF患者的随机对照试验。分析考虑了高钾血症、低血压、治疗中出现的不良事件（TEAE）、治疗中出现的严重不良事件（TESAEs）以及因不良事件导致的治疗中断。
与安慰剂相比，无论HF表型如何，非奈利酮均显著增加高钾血症（RR = 2.07，95% CI 1.77 - 2.44，P < 0.00001）和低血压（RR = 1.49，95% CI 1.31 - 1.68，P < 0.00001）的风险。在分析总体心力衰竭人群时，非奈利酮与安慰剂在TEAE、TESAEs或治疗中断方面未观察到显著差异。与依普利酮相比，非奈利酮的TEAE（RR = 0.93，95% CI：0.89 - 0.98）和TESAEs（RR = 0.74，95% CI：0.66 - 0.84）风险较低，停药率相似。此外，一项纳入研究表明，与螺内酯相比，非奈利酮在HFrEF中的TEAE（RR = 0.64，95% CI 0.56 - 0.74）、治疗中断（RR = 0.37，95% CI 0.25 - 0.54）和高钾血症（RR = 0.41，95% CI 0.21 - 0.79）风险可能较低，低血压发生率相似（RR = 0.61，95% CI 0.29 - 1.30）。
非奈利酮（10 - 25 mg）显示出与安慰剂相似的安全性，在TEAE、TESAEs或治疗中断方面无显著差异。与依普利酮相比，非奈利酮的TEAE和TESAEs较少，停药率相当。此外，在HFrEF患者中，与螺内酯相比，非奈利酮的TEAE、治疗中断和高钾血症风险可能较低，低血压发生率相似。
