TY - JOUR
T1 - Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
AU - FINEARTS-HF Committees and Investigators
AU - Solomon, Scott D.
AU - McMurray, John J.V.
AU - Vaduganathan, Muthiah
AU - Claggett, Brian
AU - Jhund, Pardeep S.
AU - Desai, Akshay S.
AU - Henderson, Alasdair D.
AU - Lam, Carolyn S.P.
AU - Pitt, Bertram
AU - Senni, Michele
AU - Shah, Sanjiv J.
AU - Voors, Adriaan A.
AU - Zannad, Faiez
AU - Abidin, Imran Zainal
AU - Alcocer-Gamba, Marco Antonio
AU - Atherton, John J.
AU - Bauersachs, Johann
AU - Chang-Sheng, Ma
AU - Chiang, Chern En
AU - Chioncel, Ovidiu
AU - Chopra, Vijay
AU - Comin-Colet, Josep
AU - Filippatos, Gerasimos
AU - Fonseca, Cândida
AU - Gajos, Grzegorz
AU - Goland, Sorel
AU - Goncalvesova, Eva
AU - Kang, Seokmin
AU - Katova, Tzvetana
AU - Kosiborod, Mikhail N.
AU - Latkovskis, Gustavs
AU - Lee, Alex Pui Wai
AU - Linssen, Gerard C.M.
AU - Llamas-Esperón, Guillermo
AU - Mareev, Vyacheslav
AU - Martinez, Felipe A.
AU - Melenovský, Vojtěch
AU - Merkely, Béla
AU - Nodari, Savina
AU - Petrie, Mark C.
AU - Saldarriaga, Clara Inés
AU - Saraiva, Jose Francisco Kerr
AU - Sato, Naoki
AU - Schou, Morten
AU - Sharma, Kavita
AU - Troughton, Richard
AU - Udell, Jacob A.
AU - Ukkonen, Heikki
AU - Vardeny, Orly
AU - Verma, Subodh
N1 - Publisher Copyright:
Copyright © 2024 Massachusetts Medical Society. All rights reserved.
PY - 2024/10/24
Y1 - 2024/10/24
N2 - 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.
AB - 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.
KW - Cardiology
KW - Cardiology General
KW - Heart Failure
UR - https://www.scopus.com/pages/publications/85207725335
U2 - 10.1056/NEJMoa2407107
DO - 10.1056/NEJMoa2407107
M3 - Article
C2 - 39225278
AN - SCOPUS:85207725335
SN - 0028-4793
VL - 391
SP - 1475
EP - 1485
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 16
ER -