Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysis
BackgroundFinerenone 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...
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Frontiers Media S.A.
2025-05-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1601552/full |
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| author | Wanqian Yu Fan Luo Jingan Rao Guangtao Lei Qinghua Wu Wen Shen Pingping Yang Ping Li |
| author_facet | Wanqian Yu Fan Luo Jingan Rao Guangtao Lei Qinghua Wu Wen Shen Pingping Yang Ping Li |
| author_sort | Wanqian Yu |
| collection | DOAJ |
| description | BackgroundFinerenone 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.MethodsA 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.ResultsFinerenone significantly increased the risk of hyperkalemia (RR = 2.07, 95% CI 1.77-2.44, P < 0.00001) and hypotension (RR = 1.49, 95% CI 1.31-1.68, P < 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.ConclusionFinerenone (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. |
| format | Article |
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| institution | Kabale University |
| issn | 2297-055X |
| language | English |
| publishDate | 2025-05-01 |
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| spelling | doaj-art-bab02f9c94244c1ea76274d5fdb8d8e02025-08-20T03:32:19ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2025-05-011210.3389/fcvm.2025.16015521601552Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysisWanqian Yu0Fan Luo1Jingan Rao2Guangtao Lei3Qinghua Wu4Wen Shen5Pingping Yang6Ping Li7Department of Cardiovascular Medicine, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, ChinaDepartment of Gastroenterology, Jiangxi Provincial Hospital of Traditional Chinese Medicine, Nanchang, Jiangxi, ChinaDepartment of Cardiovascular Medicine, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, ChinaDepartment of Cardiovascular Medicine, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, ChinaDepartment of Cardiovascular Medicine, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, ChinaDepartment of Cardiovascular Medicine, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, ChinaDepartment of Endocrinology and Metabolism, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, ChinaDepartment of Cardiovascular Medicine, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, ChinaBackgroundFinerenone 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.MethodsA 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.ResultsFinerenone significantly increased the risk of hyperkalemia (RR = 2.07, 95% CI 1.77-2.44, P < 0.00001) and hypotension (RR = 1.49, 95% CI 1.31-1.68, P < 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.ConclusionFinerenone (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.https://www.frontiersin.org/articles/10.3389/fcvm.2025.1601552/fullfinerenoneheart failureHFrEFHFmrEFHFpEFadverse effects |
| spellingShingle | Wanqian Yu Fan Luo Jingan Rao Guangtao Lei Qinghua Wu Wen Shen Pingping Yang Ping Li Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysis Frontiers in Cardiovascular Medicine finerenone heart failure HFrEF HFmrEF HFpEF adverse effects |
| title | Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysis |
| title_full | Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysis |
| title_fullStr | Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysis |
| title_full_unstemmed | Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysis |
| title_short | Adverse effects of finerenone in patients with heart failure: a systematic review and meta-analysis |
| title_sort | adverse effects of finerenone in patients with heart failure a systematic review and meta analysis |
| topic | finerenone heart failure HFrEF HFmrEF HFpEF adverse effects |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1601552/full |
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