Efficacy and Safety of Finerenone in Heart Failure With Preserved or Mildly Reduced Ejection Fraction: A Systematic Review and Meta-Analysis of Randomized Trials
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Introduction
Heart failure with preserved (HFpEF) and mildly reduced ejection fraction (HFmrEF) accounts for nearly half of all heart failure cases, yet effective therapies remain limited. Finerenone, a novel non-steroidal mineralocorticoid receptor antagonist, offers anti-fibrotic and anti-inflammatory effects with improved safety compared to steroidal MRAs. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of finerenone in HFpEF/HFmrEF.
Methods
We systematically searched PubMed, Embase, Cochrane CENTRAL, Web of Science, and Scopus through September 2025, including only randomized controlled trials. Data extraction and risk of bias (RoB 2) assessments were performed independently by two reviewers. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using random-effects models.
Results
Ten RCTs comprising 33,544 patients (20,279 males, 13,202 females) with a mean follow-up of 16.15 months were included. Finerenone significantly reduced major adverse cardiovascular events (MACE; log RR –0.11 [– 0.17, –0.05], p<0.001; I²=0%). All-cause mortality (RR –0.58, p=0.06), cardiovascular mortality (RR –0.36, p=0.06), and rehospitalization (RR –0.66, p=0.07) trended favorably but were not statistically significant. Hyperkalemia risk was significantly increased (log RR 0.73, p<0.001).
Conclusion
Finerenone reduces MACE with an acceptable safety profile, albeit with higher hyperkalemia risk. These findings support finerenone as a promising therapy for HFpEF/HFmrEF, complementing existing treatment strategies.
