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Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
Scott D Solomon1, John J V McMurray1, Muthiah Vaduganathan1
1From 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.).
Finerenone significantly reduced worsening heart failure events and cardiovascular death in patients with mildly reduced or preserved ejection fraction. This nonsteroidal mineralocorticoid receptor antagonist offers a new treatment option for this heart failure population.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Steroidal mineralocorticoid receptor antagonists (MRAs) are established treatments for heart failure with reduced ejection fraction (HFrEF).
- The efficacy of MRAs in patients with heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) remains uncertain.
- There is a need for data on the effectiveness and safety of nonsteroidal MRAs, such as finerenone, in HFmrEF and HFpEF populations.
Purpose of the Study:
- To evaluate the efficacy and safety of finerenone compared to placebo in patients with heart failure and a left ventricular ejection fraction (LVEF) of 40% or greater.
- To assess the impact of finerenone on a composite outcome of worsening heart failure events and cardiovascular death.
Main Methods:
- An international, double-blind, randomized controlled trial (FINEARTS-HF) was conducted.
- Patients with LVEF ≥40% were randomized 1:1 to receive finerenone (up to 40 mg daily) or placebo, alongside standard therapy.
- The primary outcome was a composite of total worsening heart failure events and cardiovascular death, with secondary assessments of individual components and safety.
Main Results:
- Over a median follow-up of 32 months, finerenone significantly reduced the primary composite outcome by 16% compared to placebo (rate ratio, 0.84; P=0.007).
- Worsening heart failure events were significantly lower in the finerenone group (rate ratio, 0.82; P=0.006).
- Cardiovascular death rates were similar between groups, but finerenone was associated with increased hyperkalemia and decreased hypokalemia.
Conclusions:
- Finerenone demonstrated significant efficacy in reducing the composite of worsening heart failure events and cardiovascular death in patients with HFmrEF and HFpEF.
- The findings support finerenone as a therapeutic option for patients with heart failure and LVEF ≥40%.
- Safety profile included increased risk of hyperkalemia, necessitating careful monitoring.
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