Scientific Sessions 2024  /  Featured Science: Getting Closer to the Summit: New HFpEF Treatments  /  Efficacy and safety of finerenone in patients with heart failure and mildly reduced or preserved ejection fraction: A prespecified sex-specific analysis of the FINEARTS-HF trial

American Heart Association

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Final ID: 4170814

Efficacy and safety of finerenone in patients with heart failure and mildly reduced or preserved ejection fraction: A prespecified sex-specific analysis of the FINEARTS-HF trial

Abstract Body (Do not enter title and authors here): Background: Sex-related differences are recognized in the clinical presentation, symptoms and quality of life, prognosis, and treatment response in heart failure (HF). Therefore, it is important to evaluate the efficacy and safety of new treatments for HF in both women and men.
Methods: FINEARTS-HF was a randomized, double-blind, multicenter, event-driven, trial in patients with left ventricular ejection fraction ≥40%, investigating the efficacy and safety of the non-steroidal mineralocorticoid receptor antagonist finerenone, compared to placebo, in patients with HF and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). The primary outcome was the composite of cardiovascular death and total (first and repeat) HF events (either an unplanned HF hospitalization or an urgent HF visit). In a prespecified subgroup analysis, we evaluated the efficacy and safety of finerenone compared to placebo in both women and men.
Results: Overall, 2,732 women (45.5%) and 3,269 men (54.5%) were analyzed. Women were older than men and had higher rates of obesity, lower estimated glomerular filtration rate, worse NYHA functional class, and lower Kansas City Cardiomyopathy Questionnaire-total symptom scores (KCCQ-TSS). The rate of the primary outcome in the placebo group was similar between women and men. Compared to placebo, finerenone reduced the risk of the primary outcome to a similar extent in both women and men, with rate ratios (RRs) of 0.78 (95%CI 0.65-0.95) in women versus 0.88 (0.74-1.04) in men, respectively (P for interaction = 0.41). Consistent benefits were observed for the components of the primary outcome and all-cause death (Figures 1 and 2). The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, irrespective of sex (P for interaction=0.73). Adverse events of interest were similar in both women and men.
Conclusion: In FINEARTS-HF, finerenone was efficacious and safe, irrespective of sex, in patients with HFmrEF/HFpEF.
  • Chimura, Misato  ( University of glasgow , Glasgow , United Kingdom )
  • Lam, Carolyn  ( NATIONAL HEART CENTRE SINGAPORE , Singapore , Singapore )
  • Senni, Michele  ( ASST PAPA GIOVANNI XXIII , BERGAMO , Italy )
  • Shah, Sanjiv  ( NORTHWESTERN UNIVERSITY , Chicago , Illinois , United States )
  • Voors, Adriaan  ( UNIVERSITY MEDICAL CENTER GRONINGEN , Gronien , Netherlands )
  • Zannad, Faiez  ( CVCT and Universite de Lorraine , Paris , France )
  • Pitt, Bertram  ( University of Michigan School , Ann Arbor , Michigan , United States )
  • Vaduganathan, Muthiah  ( Brigham and Womens Hospital , Boston , Massachusetts , United States )
  • Solomon, Scott  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Mcmurray, John  ( University of glasgow , Glasgow , United Kingdom )
  • Jhund, Pardeep  ( University of glasgow , Glasgow , United Kingdom )
  • Henderson, Alasdair David  ( University of glasgow , Glasgow , United Kingdom )
  • Claggett, Brian  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Desai, Akshay  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Mueller, Katharina  ( Bayer AG , Berlin , Germany )
  • Glasauer, Andrea  ( Bayer AG , Berlin , Germany )
  • Rohwedder, Katja  ( Bayer AG , Berlin , Germany )
  • Viswanathan, Prabhakar  ( Bayer AG , Berlin , Germany )
    • Author Disclosures:
    Misato Chimura: DO NOT have relevant financial relationships | Carolyn Lam: DO have relevant financial relationships ; Consultant:Alleviant Pharma, Allysta Pharma:Active (exists now) ; Other (please indicate in the box next to the company name):Us2.ai (Co-founder & Non-Executive Director):Active (exists now) ; Research Funding (PI or named investigator):Novo Nordisk, Roche Diagnostics:Active (exists now) ; Consultant:Siemens Healthcare, Us2.ai:Active (exists now) ; Consultant:ReCor Medical, Roche Diagnostics, Sanofi:Active (exists now) ; Consultant:Prosciento Inc, Quidel Corporation, Radcliffe Group:Active (exists now) ; Consultant:Medscape, Merck, Novartis, Novo Nordisk:Active (exists now) ; Consultant:Ionis Pharmaceutical, Janssen R&D LLC:Active (exists now) ; Consultant:Impulse Dynamics, Intellia Therapeutics:Active (exists now) ; Consultant:CPC Clinical Research, Eli Lilly:Active (exists now) ; Consultant:Boston Scientific, Bristol Myers Squibb:Active (exists now) ; Consultant:Biopeutics, Boehringer Ingelheim:Active (exists now) ; Consultant:Astra Zeneca, Bayer:Active (exists now) ; Consultant:AnaCardio, Applied Therapeutics:Active (exists now) | MICHELE SENNI: DO have relevant financial relationships ; Consultant:Novartis:Active (exists now) ; Consultant:Vifor:Active (exists now) ; Consultant:Cardurion :Active (exists now) ; Consultant:Novonordisk :Active (exists now) ; Consultant:Bayer:Active (exists now) ; Consultant:MSD:Active (exists now) ; Consultant:Merck :Active (exists now) ; Consultant:Boehringer :Active (exists now) ; Consultant:Astrazeneca :Active (exists now) ; Consultant:Abbott:Active (exists now) | Sanjiv Shah: DO have relevant financial relationships ; Consultant:Bayer:Active (exists now) ; Consultant:Merck:Active (exists now) ; Consultant:Axon Therapies:Active (exists now) ; Consultant:Corvia :Active (exists now) ; Consultant:Boehringer-Ingelheim:Active (exists now) ; Consultant:Bristol-Myers Squibb:Active (exists now) ; Consultant:Ionis:Active (exists now) ; Consultant:Novartis:Active (exists now) ; Consultant:Tenax:Active (exists now) ; Consultant:Intellia:Active (exists now) ; Consultant:Rivus:Active (exists now) ; Consultant:Novo Nordisk:Active (exists now) ; Consultant:Lilly:Active (exists now) ; Consultant:Pfizer:Active (exists now) ; Consultant:AstraZeneca:Active (exists now) | Adriaan Voors: DO have relevant financial relationships ; Consultant:AnaCardio:Active (exists now) ; Research Funding (PI or named investigator):NovoNordisk:Active (exists now) ; Consultant:NovoNordisk:Active (exists now) ; Consultant:Merck:Active (exists now) ; Consultant:Novartis:Active (exists now) ; Consultant:Moderna:Active (exists now) ; Consultant:EliLilly:Active (exists now) ; Consultant:Boehringer Ingelheim:Past (completed) ; Consultant:Bayer AG:Active (exists now) ; Consultant:BMS:Active (exists now) ; Consultant:Adrenomed:Past (completed) | Faiez ZANNAD: DO have relevant financial relationships ; Advisor:NovoNordisk:Past (completed) ; Advisor:Northsea:Expected (by end of conference) ; Advisor:Merck:Active (exists now) ; Advisor:CEVA:Past (completed) ; Advisor:Cellprothera:Active (exists now) ; Advisor:Cereno:Active (exists now) ; Ownership Interest:CVCT:Active (exists now) ; Advisor:Cardior:Past (completed) ; Advisor:CVRx:Active (exists now) ; Advisor:BMS:Past (completed) ; Advisor:Boehringer:Active (exists now) ; Advisor:Biopeutics:Active (exists now) ; Consultant:Owkin:Active (exists now) ; Advisor:Bayer:Active (exists now) ; Advisor:Applied Therapeutics:Past (completed) | Bertram Pitt: No Answer | Muthiah Vaduganathan: DO have relevant financial relationships ; Researcher:received research grant support, served on advisory boards, or had speaker engagements with American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, BMS, Boehringer Ingelheim, Chiesi, Cytokinetics, Lexicon Pharmaceuticals, Merck, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health, and participates on clinical trial committees for studies sponsored by AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics:Active (exists now) | Scott Solomon: DO have relevant financial relationships ; Research Funding (PI or named investigator):Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, BMS, Boston Scientific, Cytokinetics, Edgewise, Eidos/BridgeBio, Gossamer, GSK, Ionis, Lilly,NIH/NHLBI, Novartis, NovoNordisk, Respicardia, Sanofi Pasteur, Tenaya, Theracos, US2.AI:Active (exists now) ; Consultant:Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, AstraZeneca, Bayer, BMS, Cardior, Cardurion, Corvia, Cytokinetics, GSK, Intellia, Lilly, Novartis, Roche, Theracos, Quantum Genomics, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, Valo:Active (exists now) | John McMurray: DO have relevant financial relationships ; Research Funding (PI or named investigator):British Heart Foundation, National Institute for Health – National Heart Lung and Blood Institute (NIH-NHLBI), Boehringer Ingelheim, SQ Innovations, Catalyze Group. - Payment to Glasgow University:Active (exists now) ; Other (please indicate in the box next to the company name):KBP Biosciences - My employer, Glasgow University, has been paid by KBP Biosciences for my time spent scientific advisor to company to help guide clinical development in cardio-renal disease, inflammation & infection.:Past (completed) ; Consultant:WIRB-Copernicus Group Clinical Inc. - Data Safety Monitoring Board:Active (exists now) ; Other (please indicate in the box next to the company name):Bayer - My employer, Glasgow University, has been paid by Bayer for my time spent as Steering Committee member for the PANACHE trial using neladenoson bialanate and for the FINEARTS trial with finerenone. These payments were made through a Consultancy with Glasgow University and I have not received personal payments in relation to these trials/drugs.:Active (exists now) ; Other (please indicate in the box next to the company name):Glaxo Smith Kline - My employer, Glasgow University, has been paid by GSK for my time spent as Co-principal investigator and Steering Committee member, respectively, for the Harmony-Outcomes trial (albiglutide) and two trials, ASCEND-D and ASCEND-ND, using daprodustat, and meetings related to these trials. GSK has also paid my travel and accommodation for some of these meetings. These payments were made through a Consultancy with Glasgow University and I have not received personal payments in relation to these trials/drugs.:Active (exists now) ; Other (please indicate in the box next to the company name):Novartis - My employer, Glasgow University, has been paid by Novartis for my time spent as Executive Committee member and then co-principal investigator of ATMOSPHERE, co-principal investigator of the PARADIGM-HF and PARAGON-HF trials and Executive/Steering Committee member for PARADISE-MI, PERSPECTIVE and PARACHUTE-HF trials (with sacubitril/valsartan) and meetings/presentations related to these trials and aliskiren and sacubitril/valsartan. Novartis has also paid my travel and accommodation for some of these meetings. These payments were made through a Consultancy with Glasgow University and I have not received personal payments from Novartis in relation to these trials/drugs.:Active (exists now) ; Other (please indicate in the box next to the company name):Cardurion - My employer, Glasgow University, has been paid by Cardurion for my participation in a company advisory board about development of a PDE 9 inhibitor in heart failure.:Active (exists now) ; Consultant:Global Clinical Trial Partners Ltd. - Director:Active (exists now) ; Consultant:Alynylam Pharmaceuticals, Amgen, AnaCardio, AstraZeneca, Bayer, Berlin Cures, BMS, Cardurion, Cytokinetics, Ionis Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, River 2 Renal Corp.:Active (exists now) ; Other (please indicate in the box next to the company name):Theracos - My employer, Glasgow University, has been paid by Theracos for my time spent as Principal investigator for the BEST trial and meetings related to this trial. Theracos has also paid my travel and accommodation for some of these meetings. These payments were made through a Consultancy with Glasgow University and I have not received personal payments in relation to this trial/this drug.:Past (completed) ; Other (please indicate in the box next to the company name):Amgen - My employer, Glasgow University, has been paid by Amgen for my time spent as Steering Committee member for the ATOMIC-HF, COSMIC-HF and GALACTIC-HF trials and meetings and other activities related to these trials. Amgen has also paid my travel and accommodation for some of these meetings/activities. These payments were made through a Consultancy with Glasgow University and I have not received personal payments in relation to these trials/this drug.:Active (exists now) ; Other (please indicate in the box next to the company name):Cytokinetics - My employer, Glasgow University, has been paid by Cytokinetics for my time spent as Steering Committee member for the ATOMIC-HF, COSMIC-HF and GALACTIC-HF trials and meetings and other activities related to these trials. Cytokinetics has also paid my travel and accommodation for some of these meetings/activities. These payments were made through a Consultancy with Glasgow University and I have not received personal payments in relation to these trials/this drug.:Active (exists now) ; Speaker:Abbott, Alkem Metabolics, Astra Zeneca, Blue Ocean Scientific Solutions Ltd., Boehringer Ingelheim, Canadian Medical and Surgical Knowledge, Emcure Pharmaceuticals Ltd., Eris Lifesciences, European Academy of CME, Hikma Pharmaceuticals, Imagica Health, Intas Pharmaceuticals, J.B. Chemicals & Pharmaceuticals Ltd., Lupin Pharmaceuticals, Medscape/Heart.Org., ProAdWise Communications, Radcliffe Cardiology, Sun Pharmaceuticals, The Corpus, Translation Research Group, Translational Medicine Academy - personal lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):AstraZeneca - My employer, Glasgow University, has been paid by AstraZeneca (who market dapagliflozin) for my time spent as Principal Investigator of DAPA-HF and Co-principal Investigator of DELIVER and DETERMINE (trials using dapagliflozin) in heart failure and meetings and other activities related to these trials. AstraZeneca has also paid my travel and accommodation for these meetings. These payments were made through a Consultancy with Glasgow University and I have not received personal payments in relation to this trial/this drug.:Active (exists now) | Pardeep Jhund: DO have relevant financial relationships ; Speaker:Novartis:Past (completed) ; Speaker:ProAdwise Communications:Past (completed) ; Research Funding (PI or named investigator):Roche Diagnostics:Active (exists now) ; Research Funding (PI or named investigator):Analog Devices Inc:Active (exists now) ; Research Funding (PI or named investigator):AstraZeneca:Past (completed) ; Speaker:Intas Pharmaceuticals:Past (completed) ; Speaker:Sun Pharmaceuticals:Past (completed) ; Other (please indicate in the box next to the company name):Novo Nordisk - clinical trial work:Active (exists now) ; Other (please indicate in the box next to the company name):Bayer - clinical trial work:Active (exists now) ; Other (please indicate in the box next to the company name):Astrazeneca - clinical trial work:Active (exists now) ; Other (please indicate in the box next to the company name):Novartis - clinical trial work:Past (completed) ; Speaker:AstraZeneca:Past (completed) ; Advisor:Novartis:Past (completed) | Alasdair David Henderson: DO NOT have relevant financial relationships | Brian Claggett: DO have relevant financial relationships ; Consultant:Cardior:Active (exists now) ; Consultant:Eli Lilly:Active (exists now) ; Consultant:CVRx:Past (completed) ; Consultant:Intellia:Active (exists now) ; Consultant:Cytokinetics:Past (completed) ; Consultant:Cardurion:Active (exists now) | Akshay Desai: DO have relevant financial relationships ; Research Funding (PI or named investigator):Abbott:Active (exists now) ; Individual Stocks/Stock Options:DTX plus:Past (completed) ; Consultant:Veristat, Zydus:Past (completed) ; Consultant:Medpace, Porter Health, Regeneron, River2Renal, Roche, Verily:Active (exists now) ; Consultant:Merck, Medtronic, Parexel, scPharmaceuticals:Past (completed) ; Consultant:Bayer, Biofourmis, Novartis:Active (exists now) ; Consultant:Avidity, Axon Therapeutics, Boston Scientific, GlaxoSmithKline:Past (completed) ; Consultant:Abbott, Alnylam, AstraZeneca:Active (exists now) ; Research Funding (PI or named investigator):Pfizer:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) ; Research Funding (PI or named investigator):Bayer:Active (exists now) ; Research Funding (PI or named investigator):AstraZeneca:Active (exists now) ; Research Funding (PI or named investigator):Alnylam:Active (exists now) | Katharina Mueller: No Answer | Andrea Glasauer: No Answer | Katja Rohwedder: DO have relevant financial relationships ; Employee:Bayer AG:Active (exists now) | Prabhakar Viswanathan: No Answer
Meeting Info:

Scientific Sessions 2024

2024

Chicago, Illinois

Session Info:

Featured Science: Getting Closer to the Summit: New HFpEF Treatments

Sunday, 11/17/2024 , 08:00AM - 09:15AM

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