Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction

Scott D Solomon; John J V McMurray; Muthiah Vaduganathan; Brian Claggett; Pardeep S Jhund; Akshay S Desai; Alasdair D Henderson; Carolyn S P Lam; Bertram Pitt; Michele Senni; Sanjiv J Shah; Adriaan A Voors; Faiez Zannad; Imran Zainal Abidin; Marco Antonio Alcocer-Gamba; John J Atherton; Johann Bauersachs; Ma Chang-Sheng; Chern-En Chiang; Ovidiu Chioncel; Vijay Chopra; Josep Comin-Colet; Gerasimos Filippatos; Cândida Fonseca; Grzegorz Gajos; Sorel Goland; Eva Goncalvesova; Seokmin Kang; Tzvetana Katova; Mikhail N Kosiborod; Gustavs Latkovskis; Alex Pui-Wai Lee; Gerard C M Linssen; Guillermo Llamas-Esperón; Vyacheslav Mareev; Felipe A Martinez; Vojtěch Melenovský; Béla Merkely; Savina Nodari; Mark C Petrie; Clara Inés Saldarriaga; Jose Francisco Kerr Saraiva; Naoki Sato; Morten Schou; Kavita Sharma; Richard Troughton; Jacob A Udell; Heikki Ukkonen; Orly Vardeny; Subodh Verma; FINEARTS-HF Committees and Investigators

doi:10.1056/NEJMoa2407107

Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction

Scott D Solomon, John J V McMurray, Muthiah Vaduganathan, Brian Claggett, Pardeep S Jhund, Akshay S Desai, Alasdair D Henderson, Carolyn S P Lam, Bertram Pitt, Michele Senni, Sanjiv J Shah, Adriaan A Voors, Faiez Zannad, Imran Zainal Abidin, Marco Antonio Alcocer-Gamba, John J Atherton, Johann Bauersachs, Ma Chang-Sheng, Chern-En Chiang, Ovidiu ChioncelVijay Chopra, Josep Comin-Colet, Gerasimos Filippatos, Cândida Fonseca, Grzegorz Gajos, Sorel Goland, Eva Goncalvesova, Seokmin Kang, Tzvetana Katova, Mikhail N Kosiborod, Gustavs Latkovskis, Alex Pui-Wai Lee, Gerard C M Linssen, Guillermo Llamas-Esperón, Vyacheslav Mareev, Felipe A Martinez, Vojtěch Melenovský, Béla Merkely, Savina Nodari, Mark C Petrie, Clara Inés Saldarriaga, Jose Francisco Kerr Saraiva, Naoki Sato, Morten Schou, Kavita Sharma, Richard Troughton, Jacob A Udell, Heikki Ukkonen, Orly Vardeny, Subodh Verma, FINEARTS-HF Committees and Investigators

Hjertesygdomme

34 Citationer (Scopus)

Abstract

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.).

Originalsprog	Engelsk
Tidsskrift	The New England journal of medicine
Vol/bind	391
Udgave nummer	16
Sider (fra-til)	1475-1485
Antal sider	11
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa2407107
Status	Udgivet - 24 okt. 2024

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Solomon, S. D., McMurray, J. J. V., Vaduganathan, M., Claggett, B., Jhund, P. S., Desai, A. S., Henderson, A. D., Lam, C. S. P., Pitt, B., Senni, M., Shah, S. J., Voors, A. A., Zannad, F., Abidin, I. Z., Alcocer-Gamba, M. A., Atherton, J. J., Bauersachs, J., Chang-Sheng, M., Chiang, C.-E., ... FINEARTS-HF Committees and Investigators (2024). Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. The New England journal of medicine, 391(16), 1475-1485. https://doi.org/10.1056/NEJMoa2407107

Solomon, SD, McMurray, JJV, Vaduganathan, M, Claggett, B, Jhund, PS, Desai, AS, Henderson, AD, Lam, CSP, Pitt, B, Senni, M, Shah, SJ, Voors, AA, Zannad, F, Abidin, IZ, Alcocer-Gamba, MA, Atherton, JJ, Bauersachs, J, Chang-Sheng, M, Chiang, C-E, Chioncel, O, Chopra, V, Comin-Colet, J, Filippatos, G, Fonseca, C, Gajos, G, Goland, S, Goncalvesova, E, Kang, S, Katova, T, Kosiborod, MN, Latkovskis, G, Lee, AP-W, Linssen, GCM, Llamas-Esperón, G, Mareev, V, Martinez, FA, Melenovský, V, Merkely, B, Nodari, S, Petrie, MC, Saldarriaga, CI, Saraiva, JFK, Sato, N, Schou, M, Sharma, K, Troughton, R, Udell, JA, Ukkonen, H, Vardeny, O, Verma, S & FINEARTS-HF Committees and Investigators 2024, 'Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction', The New England journal of medicine, bind 391, nr. 16, s. 1475-1485. https://doi.org/10.1056/NEJMoa2407107

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title = "Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction",

abstract = "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.).",

keywords = "Aged, Female, Humans, Male, Middle Aged, Double-Blind Method, Follow-Up Studies, Heart Failure/drug therapy, Hospitalization/statistics & numerical data, Kaplan-Meier Estimate, Mineralocorticoid Receptor Antagonists/administration & dosage, Naphthyridines/administration & dosage, Stroke Volume/drug effects, Aged, 80 and over, Treatment Outcome",

author = "Solomon, {Scott D} and McMurray, {John J V} and Muthiah Vaduganathan and Brian Claggett and Jhund, {Pardeep S} and Desai, {Akshay S} and Henderson, {Alasdair D} and Lam, {Carolyn S P} and Bertram Pitt and Michele Senni and Shah, {Sanjiv J} and Voors, {Adriaan A} and Faiez Zannad and Abidin, {Imran Zainal} and Alcocer-Gamba, {Marco Antonio} and Atherton, {John J} and Johann Bauersachs and Ma Chang-Sheng and Chern-En Chiang and Ovidiu Chioncel and Vijay Chopra and Josep Comin-Colet and Gerasimos Filippatos and C{\^a}ndida Fonseca and Grzegorz Gajos and Sorel Goland and Eva Goncalvesova and Seokmin Kang and Tzvetana Katova and Kosiborod, {Mikhail N} and Gustavs Latkovskis and Lee, {Alex Pui-Wai} and Linssen, {Gerard C M} and Guillermo Llamas-Esper{\'o}n and Vyacheslav Mareev and Martinez, {Felipe A} and Vojt{\v e}ch Melenovsk{\'y} and B{\'e}la Merkely and Savina Nodari and Petrie, {Mark C} and Saldarriaga, {Clara In{\'e}s} and Saraiva, {Jose Francisco Kerr} and Naoki Sato and Morten Schou and Kavita Sharma and Richard Troughton and Udell, {Jacob A} and Heikki Ukkonen and Orly Vardeny and Subodh Verma and {FINEARTS-HF Committees and Investigators}",

note = "Copyright {\textcopyright} 2024 Massachusetts Medical Society.",

year = "2024",

month = oct,

day = "24",

doi = "10.1056/NEJMoa2407107",

language = "English",

volume = "391",

pages = "1475--1485",

journal = "The New England journal of medicine",

issn = "0028-4793",

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number = "16",

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TY - JOUR

T1 - Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction

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

AU - FINEARTS-HF Committees and Investigators

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. (Funded by Bayer; FINEARTS-HF ClinicalTrials.gov number, NCT04435626.).

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. (Funded by Bayer; FINEARTS-HF ClinicalTrials.gov number, NCT04435626.).

KW - Aged

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Double-Blind Method

KW - Follow-Up Studies

KW - Heart Failure/drug therapy

KW - Hospitalization/statistics & numerical data

KW - Kaplan-Meier Estimate

KW - Mineralocorticoid Receptor Antagonists/administration & dosage

KW - Naphthyridines/administration & dosage

KW - Stroke Volume/drug effects

KW - Aged, 80 and over

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85207725335&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2407107

DO - 10.1056/NEJMoa2407107

M3 - Journal article

C2 - 39225278

SN - 0028-4793

VL - 391

SP - 1475

EP - 1485

JO - The New England journal of medicine

JF - The New England journal of medicine

IS - 16

ER -

Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction

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