Finerenone reduced cardiovascular death and total heart failure events (RR 0.83) with >80% probability of benefit on cardiovascular and all-cause mortality in HFmrEF/HFpEF.
Does finerenone reduce cardiovascular death and total heart failure events in patients with HFmrEF/HFpEF?
A pre-specified Bayesian analysis confirms that finerenone provides a high probability of reducing cardiovascular death and total heart failure events in patients with HFmrEF/HFpEF.
Absolute Event Rate: 0% vs 0%
Abstract Background 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. Objective To estimate the probability of different magnitudes of treatment benefit with finerenone versus placebo using Bayesian analysis of FINEARTS-HF. Methods 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. Results Among 6,001 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
Henderson et al. (Sat,) reported a other. Finerenone reduced cardiovascular death and total heart failure events (RR 0.83) with >80% probability of benefit on cardiovascular and all-cause mortality in HFmrEF/HFpEF.