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American Heart Association

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Final ID: 4369294

Estimated Lifetime Benefits of Finerenone on Cardiorenal Morbidity and Mortality in Patients with Type 2 Diabetes and Chronic Kidney Disease

Abstract Body (Do not enter title and authors here):
Introduction: Finerenone, a non-steroidal mineralocorticoid receptor antagonist, improves cardiovascular and kidney outcomes in people with type 2 diabetes and chronic kidney disease (CKD). However, the long-term impact of finerenone on delaying or preventing cardiorenal events is not known.

Purpose: To estimate the lifetime benefits of finerenone vs. placebo on cardiorenal morbidity and mortality in persons with type 2 diabetes and CKD.

Methods: In this participant-level pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials (FIDELITY), we estimated the effects of finerenone on long-term survival free from cardiorenal morbidity and mortality using validated, nonparametric, and age-based actuarial methods. The main outcome was a cardiorenal composite outcome comprised of all-cause death and the individual components of the prespecified cardiovascular (heart failure hospitalization, non-fatal myocardial infarction, or non-fatal stroke) and kidney (CKD progression [sustained ≥57% decrease in eGFR] or kidney failure) composite endpoints.

Results: Among 12,990 pooled trial participants, the risk of cardiorenal morbidity or mortality was lower with finerenone (71.8 events per 1000 person-years) vs. placebo (85.4 events per 1000 patient years; HR, 0.84 [95% CI, 0.78 to 0.90]) over a median trial follow-up of 3.0 [2.3, 3.8] years. In actuarial analyses examining lifetime trajectories for a 65-year-old trial participant, mean survival free from cardiorenal morbidity or mortality was 10.2 years (95% CI, 9.7 to 10.7) with placebo and 11.5 years (95% CI, 11.0 to 12.0) with finerenone, representing an additional 1.3 years (95% CI, 0.6 to 2.0 years) of event-free survival (Figure, Panel A). Cardiorenal event-free survival gains were observed across a broad age range, from 1.2 years (95% CI, 0.2 to 2.3 years) at age 55 to 0.8 years (95% CI, 0.1 to 1.4 years) at age 75 (Figure, Panel B).

Conclusions: Treatment with finerenone is projected to afford clinically relevant long-term gains in survival free from cardiorenal morbidity and mortality, reinforcing its role as a key component of guideline-directed medical therapy for persons with type 2 diabetes and CKD.
  • Ostrominski, John  ( Brigham and Womens Hospital , Boston , Massachusetts , United States )
  • Schloemer, Patrick  ( Bayer AG , Berlin , Germany )
  • Rohwedder, Katja  ( Bayer AG , Berlin , Germany )
  • Mcmurray, John  ( BHF CARDIOVASCULAR RESEARCH CENTRE , Glasgow , United Kingdom )
  • Solomon, Scott  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Vaduganathan, Muthiah  ( Brigham and Womens Hospital , Boston , Massachusetts , United States )
  • Anker, Stefan  ( charite , Berlin , Germany )
  • Neuen, Brendon  ( George Institute for Global Health , Newtown , New South Wales , Australia )
  • Claggett, Brian  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Agarwal, Rajiv  ( VA Indianapolis , INDIANAPOLIS , Indiana , United States )
  • Filippatos, Gerasimos  ( NKUA , Chaidari , Greece )
  • Rossing, Peter  ( Steno Diabetes Center Copenhagen , Gentofte , Denmark )
  • Ruilope, Luis  ( Hospital 12 de Octubre , Madrid , Spain )
  • Brinker, Meike  ( Bayer AG , Berlin , Germany )
  • Lage, Andrea  ( Bayer SA , Sao Paulo , Brazil )
  • Author Disclosures:
    John Ostrominski: DO NOT have relevant financial relationships | Patrick Schloemer: DO have relevant financial relationships ; Employee:Bayer AG:Active (exists now) | Katja Rohwedder: DO have relevant financial relationships ; Employee:Bayer AG:Active (exists now) | John McMurray: DO NOT have relevant financial relationships | 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, Askbio, 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, Synhale, Recordati:Active (exists now) | Muthiah Vaduganathan: DO have relevant financial relationships ; Consultant:American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Bristol Myers Squibb, Boehringer Ingelheim, Chiesi, Cytokinetics, Esperion, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Milestone Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi and Tricog Health:Active (exists now) ; Research Funding (PI or named investigator):Amgen, AstraZeneca, Boehringer Ingelheim, Galmed, Novartis, Bayer AG, Occlutech, Pharmacosmos, and Impulse Dynamics:Active (exists now) | Stefan Anker: DO have relevant financial relationships ; Research Funding (PI or named investigator):CSL/Vifor & Abbott Laboratories.:Past (completed) ; Royalties/Patent Beneficiary:Named co-inventor of two patent applications regarding MR-proANP (DE 102007010834 & DE 102007022367), but he does not benefit personally from the related issued patents.:Active (exists now) ; Consultant:Actimed, Alleviant, Astra Zeneca, Bayer, Berlin Heals, Boehringer Ingelheim, Brahms, Cardiac Dimensions, Cardior, Cordio, CVRx, Cytokinetics, Edwards, Impulse Dynamics, Lilly, Mankind Pharma, Novo Nordisk, Occlutech, Pfizer, Regeneron, Relaxera, Repairon, Scirent, Sensible Medical, Vectorious, Vivus, & V-Wave:Active (exists now) | Brendon Neuen: DO have relevant financial relationships ; Consultant:AstraZeneca:Active (exists now) ; Other (please indicate in the box next to the company name):Menarini - publication support:Active (exists now) ; Consultant:Travere:Active (exists now) ; Consultant:Otsuka:Active (exists now) ; Consultant:Novo Nordisk:Active (exists now) ; Other (please indicate in the box next to the company name):CSL Behring - travel support:Active (exists now) ; Consultant:CSL Seqirus:Active (exists now) ; Consultant:Boehringer and Ingelheim:Active (exists now) ; Consultant:Bayer:Active (exists now) ; Consultant:Alexion:Active (exists now) | Brian Claggett: No Answer | Rajiv Agarwal: No Answer | Gerasimos Filippatos: DO have relevant financial relationships ; Research Funding (PI or named investigator):European Union:Active (exists now) ; Advisor:MSD:Active (exists now) ; Other (please indicate in the box next to the company name):Vifor/Trial Committee member:Past (completed) ; Advisor:Servier:Past (completed) ; Other (please indicate in the box next to the company name):Medtronic/ Trial Committee member:Past (completed) ; Advisor:Boehringer Ingelheim:Active (exists now) ; Advisor:Bayer:Active (exists now) ; Advisor:Novo Nordisc:Active (exists now) ; Other (please indicate in the box next to the company name):Windtree?Trial Committee:Active (exists now) ; Other (please indicate in the box next to the company name):Impulse/Trial Committee:Active (exists now) ; Advisor:Novartis:Past (completed) | Peter Rossing: DO have relevant financial relationships ; Consultant:Novo Nordisk A/S:Active (exists now) ; Consultant:Abbott:Past (completed) ; Consultant:Sanofi:Past (completed) ; Consultant:Gilead:Past (completed) ; Consultant:Eli Lilly:Active (exists now) ; Speaker:daichii sankyo:Past (completed) ; Consultant:Boehringer Ingelheim:Active (exists now) ; Other (please indicate in the box next to the company name):Lexicon:Active (exists now) ; Consultant:Roche:Active (exists now) ; Consultant:amgen:Active (exists now) ; Consultant:AstraZeneca:Active (exists now) ; Consultant:Bayer:Active (exists now) | Luis Ruilope: No Answer | Meike Brinker: No Answer | Andrea Lage: DO have relevant financial relationships ; Employee:Bayer SA:Active (exists now)
Meeting Info:

Scientific Sessions 2025

2025

New Orleans, Louisiana

Session Info:

Refining Therapeutic Approaches for CKM Syndrome

Saturday, 11/08/2025 , 01:30PM - 02:35PM

Abstract Oral Session

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