A Bayesian analysis of finerenone in heart failure with mildly reduced and preserved ejection fraction: a pre-specified analysis of FINEARTS-HF
Year: 2026
Type: article
Abstract: AIMS: The non-steroidal mineralocorticoid receptor agonist (MRA) finerenone reduced heart failure events and cardiovascular death in patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) in a frequentist analysis of the FINEARTS-HF trial. We applied Bayesian methods including prior information to provide probabilistic estimates of efficacy and safety. The aim of this study was to estimate the probability of different magnitudes of treatment benefit with finerenone vs. placebo using Bayesian analysis of FINEARTS-HF. METHODS AND RESULTS: In this pre-specified Bayesian analysis, we estimated treatment efficacy incorporating prior information in a robust meta-analytic predictive (MAP) prior using data from two finerenone trials (FIDELIO-DKD and FIGARO-DKD) and a steroidal MRA spironolactone (TOPCAT). We compared results using vague priors and informative MAP priors. The primary outcome was cardiovascular death and total heart failure events. Among 6001 patients, Bayesian analysis with vague priors confirmed the frequentist results of a reduction in the rate of the primary outcome [RR 0.83; 95% credible interval (CrI) 0.74-0.94]. Incorporating prior evidence increased the posterior probability of a ≥ 10% reduction in the primary event rate from 90% to 92%. The probability that finerenone reduced cardiovascular death was 80% (HR 0.93, 95% CrI: 0.79-1.10), and all-cause mortality was 85% (HR 0.94, 95% CrI: 0.83-1.06). Finerenone increased the probability of hyperkalaemia and decreased the probability of hypokalaemia. CONCLUSION: The non-steroidal MRA finerenone reduced the rate of cardiovascular death and total heart failure events under both frequentist and Bayesian inference methods. The probability of benefit exceeded 80% for both cardiovascular and all-cause mortality with finerenone. Trial Registration: ClinicalTrials.gov Identifier: NCT04435626.
Authors: Alasdair D Henderson, Kieran F Docherty, Atefeh Talebi, Toru Kondo, Mark C Petrie, Brian L Claggett, Akshay S Desai, Muthiah Vaduganathan, John J Atherton, Johan Bauersachs, Morten Schou, Subodh Verma, Carolyn S P Lam, Bertram Pitt, Michele Senni, Sanjiv J Shah, Adriaan A Voors, Faiez Zannad, Meike Brinker, Flaviana Amarante, Katja Rohwedder, James Lay-Flurrie, Scott D Solomon, John J V McMurray, Pardeep S Jhund
Institutions: University of Glasgow, Nagoya University, Brigham and Women's Hospital, Harvard University, The University of Queensland, Royal Brisbane and Women's Hospital, Medizinische Hochschule Hannover, Herlev Hospital, Gentofte Hospital, St. Michael's Hospital, National University of Singapore, National University Heart Centre Singapore, Duke-NUS Medical School, National Heart Centre Singapore, University of Michigan, Ospedale Papa Giovanni XXIII, University of Milano-Bicocca, Northwestern University, University of Groningen, Inserm, Centre Hospitalier Régional et Universitaire de Nancy, Université de Lorraine, Bayer (Germany)
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,501
Funder: Bayer
OpenAlex ID: W7129030137
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