Efficacy and Safety of Finerenone in Heart Failure With Preserved Ejection Fraction
John W. Ostrominski, Gerasimos Filippatos, Brian Claggett, Zi Michael Miao, Akshay S. Desai, Pardeep S. Jhund, Alasdair D Henderson, Markus F. Scheerer, Katja Rohwedder, Flaviana Amarante, Meike Brinker, James Lay‐Flurrie, Carolyn S.P. Lam, Michele Senni, Sanjiv J. Shah, Adriaan A. Voors, Faiez Zannad, Peter Rossing, Luís M. Ruilope, Stefan D. Anker, Bertram Pitt, Rajiv Agarwal, John J.V. McMurray, Scott D. Solomon, Muthiah Vaduganathan
Abstract
BACKGROUND: Pooling data from participants with heart failure with mildly reduced ejection fraction (HFmrEF) or heart failure with preserved ejection fraction (HFpEF) from all completed outcomes trials evaluating finerenone to date may enhance understanding of its safety and efficacy in this high-risk and heterogeneous population. OBJECTIVES: In this prespecified participant-level pooled analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials (FINE-HEART), we evaluated the safety and efficacy of finerenone in individuals with HFmrEF/HFpEF. METHODS: The treatment effects of finerenone vs placebo on cardiovascular death or heart failure hospitalization were evaluated using Cox proportional hazards regression models stratified by trial. Additional endpoints included cardiovascular death, HF hospitalization, new-onset atrial fibrillation, and all-cause death. RESULTS: = 0.93). Finerenone additionally appeared to reduce heart failure hospitalization (HR: 0.84 [95% CI: 0.74-0.94]; P = 0.003) and new-onset atrial fibrillation (HR: 0.75 [95% CI: 0.58-0.97]; P = 0.030), but did not statistically significantly decrease cardiovascular death or all-cause death. Hyperkalemia was more common, and hypokalemia was less common, with finerenone vs placebo. Serious adverse events were similar between the treatment arms. CONCLUSIONS: This participant-level pooled analysis of 3 large-scale outcomes trials supports the use of finerenone in individuals with HFmrEF/HFpEF across a broad range of cardiovascular-kidney-metabolic risk. (FINE-HEART: An Integrated Pooled Analysis of Finerenone across 3 Phase III Trials of Heart Failure and Chronic Kidney Disease and Type 2 Diabetes; CRD42024570467).