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spelling Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection FractionA Secondary Analysis of the FINEARTS-HF Randomized Clinical TrialCardiology and Cardiovascular MedicineSDG 3 - Good Health and Well-beingPublisher Copyright: Copyright © 2024 Chimura M et al.Importance: Sex is associated with the clinical presentation, outcomes, and response to treatment in patients with heart failure (HF). However, little is known about the safety and efficacy of treatment with finerenone according to sex. Objective: To estimate the efficacy and safety of finerenone compared with placebo in both women and men. Design, Setting, and Participants: Prespecified analyses were conducted in the phase 3 randomized clinical trial Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF). The trial was conducted across 653 sites in 37 countries. Participants were adults aged 40 years and older with symptomatic HF and left ventricular ejection fraction (LVEF) of 40% or greater randomized between September 2020 and January 2023. Intervention: Finerenone (titrated to 20 mg or 40 mg) or placebo. Main Outcomes and Measures: The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits). Results: A total of 6001 patients were randomized in FINEARTS-HF, of whom 2732 were women (45.5%), with a mean (SD) age of 73.6 (9.1) years. Women had higher rates of any obesity, higher LVEF (54.6 [7.6%] vs 50.9 [7.6] for men), lower mean (SD) estimated glomerular filtration rate than men (59.7 [19.1] vs 64.1 [20.0] for men; P<.001), worse New York Heart Association functional class, and lower Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) (mean [SD] 62.3 [24.0] vs 71.0 [23.1]). The incident rate of the primary outcome was slightly lower in women (15.7; 95% CI, 14.3-17.3) than in men (16.8; 95% CI, 15.4-18.3) per 100 person-years. Compared with placebo, finerenone reduced the risk of the primary end point similarly in women and men: rate ratio 0.78 (95% CI, 0.65-0.95) in women and 0.88 (95% CI, 0.74-1.04) in men (P =.41 for interaction). Consistent effects were observed for the components of the primary outcome and all-cause mortality. The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex (P =.73 for interaction). Finerenone had similar tolerability in women and men. Conclusions and Relevance: In FINEARTS-HF, finerenone reduced the risk of the primary end point similarly in women and men with heart failure with mildly reduced or preserved ejection fraction. Finerenone had similar tolerability in women and men.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNChimura, MisatoWang, XiaowenJhund, Pardeep S.Henderson, Alasdair D.Claggett, Brian L.Desai, Akshay S.Fonseca, CândidaGoncalvesova, EvaKatova, TzvetanaMueller, KatharinaGlasauer, AndreaRohwedder, KatjaViswanathan, PrabhakarNodari, SavinaLam, Carolyn S.P.Saldarriaga, Clara InésSenni, MicheleSharma, KavitaVoors, Adriaan A.Zannad, FaiezPitt, BertramVardeny, OrlyVaduganathan, MuthiahSolomon, Scott D.McMurray, John J.V.2025-02-10T21:19:47Z2025-01-082025-01-08T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article12application/pdfhttp://hdl.handle.net/10362/178777eng2380-6583PURE: 109184488https://doi.org/10.1001/jamacardio.2024.4613info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2025-04-14T01:38:13Zoai:run.unl.pt:10362/178777Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-28T20:39:31.705815Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse
dc.title.none.fl_str_mv Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial
title Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
spellingShingle Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Chimura, Misato
Cardiology and Cardiovascular Medicine
SDG 3 - Good Health and Well-being
title_short Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
title_full Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
title_fullStr Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
title_full_unstemmed Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
title_sort Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
author Chimura, Misato
author_facet Chimura, Misato
Wang, Xiaowen
Jhund, Pardeep S.
Henderson, Alasdair D.
Claggett, Brian L.
Desai, Akshay S.
Fonseca, Cândida
Goncalvesova, Eva
Katova, Tzvetana
Mueller, Katharina
Glasauer, Andrea
Rohwedder, Katja
Viswanathan, Prabhakar
Nodari, Savina
Lam, Carolyn S.P.
Saldarriaga, Clara Inés
Senni, Michele
Sharma, Kavita
Voors, Adriaan A.
Zannad, Faiez
Pitt, Bertram
Vardeny, Orly
Vaduganathan, Muthiah
Solomon, Scott D.
McMurray, John J.V.
author_role author
author2 Wang, Xiaowen
Jhund, Pardeep S.
Henderson, Alasdair D.
Claggett, Brian L.
Desai, Akshay S.
Fonseca, Cândida
Goncalvesova, Eva
Katova, Tzvetana
Mueller, Katharina
Glasauer, Andrea
Rohwedder, Katja
Viswanathan, Prabhakar
Nodari, Savina
Lam, Carolyn S.P.
Saldarriaga, Clara Inés
Senni, Michele
Sharma, Kavita
Voors, Adriaan A.
Zannad, Faiez
Pitt, Bertram
Vardeny, Orly
Vaduganathan, Muthiah
Solomon, Scott D.
McMurray, John J.V.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
RUN
dc.contributor.author.fl_str_mv Chimura, Misato
Wang, Xiaowen
Jhund, Pardeep S.
Henderson, Alasdair D.
Claggett, Brian L.
Desai, Akshay S.
Fonseca, Cândida
Goncalvesova, Eva
Katova, Tzvetana
Mueller, Katharina
Glasauer, Andrea
Rohwedder, Katja
Viswanathan, Prabhakar
Nodari, Savina
Lam, Carolyn S.P.
Saldarriaga, Clara Inés
Senni, Michele
Sharma, Kavita
Voors, Adriaan A.
Zannad, Faiez
Pitt, Bertram
Vardeny, Orly
Vaduganathan, Muthiah
Solomon, Scott D.
McMurray, John J.V.
dc.subject.por.fl_str_mv Cardiology and Cardiovascular Medicine
SDG 3 - Good Health and Well-being
topic Cardiology and Cardiovascular Medicine
SDG 3 - Good Health and Well-being
description Publisher Copyright: Copyright © 2024 Chimura M et al.
publishDate 2025
dc.date.none.fl_str_mv 2025-02-10T21:19:47Z
2025-01-08
2025-01-08T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/178777
url http://hdl.handle.net/10362/178777
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 2380-6583
PURE: 109184488
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