Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction.

N Engl J Med

From the Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (S.D.S., M.V., B.C., A.S.D.); British Heart Foundation Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow (J.J.V.M., P.S.J., A.D.H., M.C.P.), and Bayer, Reading (J.L.-F.) - both in the United Kingdom; National Heart Centre Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); University of Michigan School of Medicine, Ann Arbor (B.P.); University of Milano-Bicocca and Papa Giovanni XXIII Hospital, Bergamo (M. Senni), and the Department of Cardiology, University of Brescia, and ASST "Spedali Civili" Hospital, Brescia (S.N.) - all in Italy; Northwestern University Feinberg School of Medicine, Chicago (S.J.S.); University Medical Center Groningen, Groningen (A.A.V.), the Department of Cardiology, Hospital Group Twente, Almelo (G.C.M.L.), and Bayer, Hoofddorp (I.G.) - all in the Netherlands; Université de Lorraine, INSERM Clinical Investigation Centre, Centre Hospitalier Universitaire, Nancy, France (F.Z.); University of Malaya, Kuala Lumpur, Malaysia (I.Z.A.); Centro de Estudios Clínicos de Querétaro, Santiago de Querétaro (M.A.A.-G.), and Hospital Cardiologico Aguascalientes, Aguascalientes (G.L.-E.) - both in Mexico; Cardiology Research Department, Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, Australia (J.J.A.); the Department of Cardiology and Angiology, Hannover Medical School, Hannover (J.B.), and Bayer, Wuppertal (P.K.) - both in Germany; Beijing Anzhen Hospital, Capital Medical University, Beijing (M.C.-S.); General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital, and National Yang Ming Chiao Tung University, Taipei, Taiwan (C.-E.C.); Emergency Institute for Cardiovascular Diseases "Prof. Dr. C.C. Iliescu," University of Medicine Carol Davila, Bucharest, Romania (O.C.); Clinical Cardiology, Heart Failure and Research, Max Super Specialty Hospital, New Delhi, India (V.C.); the Department of Cardiology, Bellvitge University Hospital, and Bellvitge Biomedical Research Institute, Centro de Investigación Biomédica En Red Enfermedades Cardiovasculares, University of Barcelona, L'Hospitalet de Llobregat, Barcelona (J.C.-C.); the Department of Cardiology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens (G.F.); the Department of Internal Medicine, Hospital São Francisco Xavier, and NOVA Medical School, Universidade Nova de Lisboa, Lisbon, Portugal (C.F.); the Department of Coronary Disease and Heart Failure, Jagiellonian University Medical College, Krakow, Poland (G.G.); the Heart Institute, Kaplan Medical Center, Rehovot, and Hebrew University, Jerusalem - both in Israel (S.G.); the Faculty of Medicine, Comenius University, Bratislava, Slovakia (E.G.); the Division of Cardiology, Severance Hospital, and Yonsei University Health System, Seoul, South Korea (S.K.); the Department of Noninvasive Cardiology, National Cardiology Hospital, Sofia, Bulgaria (T.K.); St. Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia (G.L.); Li Ka Shing Institute of Health Sciences, the Chinese University of Hong Kong, Hong Kong (A.P.-W.L.); University Clinic of Lomonosov Moscow State University, Moscow (V. Mareev); Universidad Nacional de Córdoba, Córdoba, Argentina (F.A.M.); the Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (V. Melenovský); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Centro Cardiovascular Colombiano, Clínica Santa María, Medellin, Colombia (C.I.S.); Cardiovascular Division, Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.), and Bayer, São Paulo (F.A.) - both in Brazil; Kawaguchi Cardiovascular and Respiratory Hospital, Saitama, Japan (N.S.); the Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark (M. Schou); the Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore (K.S.); Christchurch Heart Institute, Department of Medicine, University of Otago, Christchurch, New Zealand (R.T.); Women's College Hospital and Peter Munk Cardiac Centre, Toronto General Hospital (J.A.U.), University of Toronto (J.A.U., S.V.), and the Division of Cardiac Surgery, St. Michael's Hospital (S.V.), Toronto, and the Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg (S.Z.) - both in Canada; Heart Centre, Turku University Hospital, Turku, Finland (H.U.); the Department of Medicine, University of Minnesota, and Minneapolis VA Health Care System, Minneapolis (O.V.); the Department of Internal Medicine, Division of Cardiology, Medical University of Graz, Graz, Austria (D.L.); National Scientific Center, Strazhesko Institute of Cardiology, National Academy of Medical Sciences, Kyiv, Ukraine (L.V.); Dokuz Eylul University Medical Faculty, Cardiology Department, Izmir, Turkey (M.B.Y.); and Bayer, Whippany, NJ (P.V.).

Published: October 2024

Steroidal mineralocorticoid receptor antagonists help patients with heart failure and reduced ejection fraction, but their effectiveness in those with mildly reduced or preserved ejection fraction is unclear, indicating a need for further research on finerenone.
In a double-blind study, patients with heart failure (ejection fraction 40% or greater) were assigned to receive either finerenone or a placebo to assess its impact on heart failure events and cardiovascular death.
Results showed that finerenone led to fewer worsening heart failure events and a lower overall rate of primary outcome events compared to placebo, although it also carried a higher risk of hyperkalemia.

Background: Steroidal mineralocorticoid receptor antagonists reduce morbidity and mortality among patients with heart failure and reduced ejection fraction, but their efficacy in those with heart failure and mildly reduced or preserved ejection fraction has not been established. Data regarding the efficacy and safety of the nonsteroidal mineralocorticoid receptor antagonist finerenone in patients with heart failure and mildly reduced or preserved ejection fraction are needed.

Methods: In this international, double-blind trial, we randomly assigned patients with heart failure and a left ventricular ejection fraction of 40% or greater, in a 1:1 ratio, to receive finerenone (at a maximum dose of 20 mg or 40 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of total worsening heart failure events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes. The components of the primary outcome and safety were also assessed.

Results: Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients in the finerenone group, and 1283 primary-outcome events occurred in 719 of 2998 patients in the placebo group (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007). The total number of worsening heart failure events was 842 in the finerenone group and 1024 in the placebo group (rate ratio, 0.82; 95% CI, 0.71 to 0.94; P = 0.006). The percentage of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). Finerenone was associated with an increased risk of hyperkalemia and a reduced risk of hypokalemia.

Conclusions: In patients with heart failure and mildly reduced or preserved ejection fraction, finerenone resulted in a significantly lower rate of a composite of total worsening heart failure events and death from cardiovascular causes than placebo. (Funded by Bayer; FINEARTS-HF ClinicalTrials.gov number, NCT04435626.).

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http://dx.doi.org/10.1056/NEJMoa2407107	DOI Listing

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