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Meta-Analysis
. 2025 Feb;48(2):e70065.
doi: 10.1002/clc.70065.

Cardiovascular Efficacy and Safety of Finerenone: A Meta-Analysis of Randomized Controlled Trials

Mushood Ahmed  1 , Areeba Ahsan  2 , Aimen Shafiq  3 , Muhammad Talha Maniya  4 , Hritvik Jain  5 , Javed Iqbal  6 , Muhammad Abdullah Naveed  3 , Raheel Ahmed  7   8 , Jamal S Rana  9   10 , Marat Fudim  11   12 , Gregg C Fonarow  13
Affiliations
Meta-Analysis

Cardiovascular Efficacy and Safety of Finerenone: A Meta-Analysis of Randomized Controlled Trials

Mushood Ahmed et al. Clin Cardiol. 2025 Feb.

Abstract

Background: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, has emerged as a novel therapeutic option for the management of patients with diabetes, chronic kidney disease, or heart failure. We seek to summarize the evidence on the drug's effectiveness regarding cardiovascular (CV) outcomes.

Methods: We conducted a literature search of Pubmed, Cochrane CENTRAL, Embase, and ClinicalTrials.gov from inception to September 2024. Trials exploring the effects of finerenone on CV outcomes were extracted and analyzed. The results of pooled analyses were presented as risk ratios (RRs) with 95% confidence intervals (CIs).

Results: A total of eight trials, incorporating 21 200 patients, were included. The pooled analysis demonstrated a significant reduction in all-cause death (RR 0.92, 95% CI: 0.85-0.99), major adverse CV events (RR 0.85, 95% CI: 0.81-0.90), heart failure-related hospitalizations or unplanned hospital visits (RR 0.82, 95% CI: 0.76-0.87) with finerenone administration compared to control. Finerenone use was associated with a trend of reduced risk of CV death without reaching statistical significance (RR 0.90, 95% CI: 0.81-1.00). The risk of myocardial infarction (RR 0.91, 95% CI: 0.74-1.12), adverse events (RR 0.96, 95% CI: 0.89-1.03), adverse events leading to discontinuation (RR 1.06, 95% CI: 0.96-1.17) remained comparable across both groups. However, an increased risk of hyperkalemia (RR 2.07, 95% CI: 1.88-2.27) was observed with finerenone therapy compared to the control group.

Conclusion: Finerenone administration was associated with improved CV outcomes in the CV-renmetabolic conditions compared to the control group.

Keywords: cardiovascular; chronic kidney disease; finerenone; heart failure.

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Conflict of interest statement

Dr Fonarow reported receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Eli Lilly, Johnson & Johnson, Medtronic, Merck, Novartis, and Pfizer outside the submitted work. Dr Fudim reported receiving personal fees from Alleviant, Ajax, Alio Health, Alleviant, Artha, Audicor, Axon Therapies, Bayer, Bodyguide, Bodyport, Boston Scientific, Broadview, Cadence, Cardioflow, Cardionomics, Coridea, CVRx, Daxor, Deerfield Catalyst, Edwards LifeSciences, Echosens, EKO, Feldschuh Foundation, Fire1, FutureCardia, Galvani, Gradient, Hatteras, HemodynamiQ, Impulse Dynamics, Intershunt, Medtronic, Merck, NIMedical, NovoNordisk, NucleusRx, NXT Biomedical, Orchestra, Pharmacosmos, PreHealth, Presidio, Procyreon, ReCor, Rockley, SCPharma, Shifamed, Splendo, Summacor, SyMap, Verily, Vironix, Viscardia, and Zoll; and receiving grants from the National Institutes of Health, Doris Duke, outside the submitted work. No other disclosures were reported.

Figures

Figure 1
Figure 1
Risk of bias summary in included trials.
Figure 2
Figure 2
Forest plots for (A) all‐cause death and (B) CV death. CV, cardiovascular.
Figure 3
Figure 3
Forest plots for (A) MACE and (B) HHF. HHF, heart failure‐related hospitalizations or unplanned hospital visits.
Figure 4
Figure 4
Forest plots for (A) myocardial infarction, (B) adverse events, (C) adverse events leading to discontinuation, and (D) hyperkalemia.
See this image and copyright information in PMC

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