Key result
Finerenone increases hyperkalemia risk ~107% versus placebo in HF, alongside more hypotension.
Why the study?
Finerenone improves heart failure outcomes across ejection fraction phenotypes, but its clinical use is accompanied by notable adverse effects that required relative risk evaluation.
Does finerenone increase the risk of adverse events compared to placebo, eplerenone, or spironolactone in patients with heart failure?
Meta-Analysis (n=8,527)
Does finerenone increase the risk of adverse events compared to placebo, eplerenone, or spironolactone in patients with heart failure?
Effect estimate: RR 2.07 (95% CI 1.77-2.44)
Absolute Event Rate: 14% vs 6.8%
p-value: p=<0.00001
Finerenone increases the risk of hyperkalemia and hypotension compared to placebo in heart failure patients, but shows a similar overall safety profile for serious adverse events and may have fewer adverse events than steroidal MRAs like eplerenone or spironolactone.
May warrant potassium and blood pressure monitoring with finerenone in heart failure; confirms the adverse event profile versus placebo in this meta-analysis.
Background: 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. Methods: 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. Results: < 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. Conclusion: 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.
No takes yet. Share an insight, caveat, or question.
Yu et al. (2025) conducted a meta-analysis in Heart failure (n=8,527). Finerenone vs. Placebo, eplerenone, or spironolactone was evaluated on Hyperkalemia (RR 2.07, 95% CI 1.77-2.44, p=<0.00001). Finerenone significantly increased the risk of hyperkalemia (RR 2.07) and hypotension (RR 1.49) compared to placebo in patients with heart failure, while overall treatment-emergent adverse events remained similar.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: