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, Dirk von Lewinski, Leonid Voronkov, Mehmet Birhan Yilmaz, Shelley Zieroth, James Lay-Flurrie, Ilse van Gameren, Flaviana Amarante, Peter Kolkhof, Prabhakar Viswanathan
{"title":"Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction.","authors":"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, Dirk von Lewinski, Leonid Voronkov, Mehmet Birhan Yilmaz, Shelley Zieroth, James Lay-Flurrie, Ilse van Gameren, Flaviana Amarante, Peter Kolkhof, Prabhakar Viswanathan","doi":"10.1056/NEJMoa2407107","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":null,"pages":null},"PeriodicalIF":96.2000,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"New England Journal of Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1056/NEJMoa2407107","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/1 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
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.).
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