Abstract
Cardiovascular-kidney-metabolic syndrome is an emerging entity that connects cardiovascular diseases, chronic kidney disease, and diabetes. The non-steroidal mineralocorticoid receptor antagonist, finerenone, has been studied in three prospective randomized clinical trials of patients with cardio-kidney-metabolic syndrome: FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF. In light of the strong epidemiological overlap and shared mechanistic drivers of clinical outcomes across cardio-kidney-metabolic syndrome, we summarize the efficacy and safety of finerenone on cardiovascular, kidney, and mortality outcomes in this prespecified participant-level pooled analysis. The three trials included 18,991 participants (mean age 67 ± 10 years; 35% women). During 2.9 years median follow-up, the primary outcome of cardiovascular death occurred in 421 (4.4%) assigned to finerenone and 471 (5.0%) assigned to placebo (HR 0.89; 95% CI 0.78-1.01; P = 0.076). Death from any cause occurred in 1,042 (11.0%) participants in the finerenone arm and 1,136 (12.0%) in the placebo arm (HR 0.91; 95% CI 0.84-0.99; P = 0.027). Finerenone further reduced the risk of HF hospitalization (HR 0.83; 95% CI 0.75-0.92; P < 0.001) and the composite kidney outcome (HR 0.80; 95% CI 0.72-0.90; P < 0.001). While this pooled analysis failed to demonstrate significant reductions in cardiovascular death, finerenone was associated with significantly lower deaths of any cause, cardiovascular events, and kidney outcomes. PROSPERO identifier: CRD42024570467
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Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
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National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece
Gerasimos Filippatos
University of Glasgow, Glasgow, Scotland, UK
Pardeep S. Jhund,Alasdair Henderson&John J. V. McMurray
Bayer, Research & Development, Pharmaceuticals, Berlin, Germany
Meike Brinker,Peter Kolkhof,Patrick Schloemer,James Lay-Flurrie&Prabhakar Viswanathan
National Heart Centre Singapore & Duke-National University of Singapore, Singapore, Singapore
Carolyn S. P. Lam
University of Milano-Bicocca ASST Papa Giovanni XXIII Hospital, Bergamo, Italy
Michele Senni
Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Sanjiv J. Shah
University of Groningen, Groningen, Netherlands
Adriaan A. Voors
University of Lorraine, Nancy, France
Faiez Zannad
Steno Diabetes Center Copenhagen, Herlev, Denmark and University of Copenhagen, Copenhagen, Denmark
Peter Rossing
Hospital 12 de Octubre, Madrid, Spain
Luis M. Ruilope
Charité University, Berlin, Germany
Stefan D. Anker
University of Michigan, Ann Arbor, Michigan, USA
Bertram Pitt
Indiana University School of Medicine, Indianapolis, Indiana, USA
Rajiv Agarwal
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- Muthiah Vaduganathan
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- Gerasimos Filippatos
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- Brian L. Claggett
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- Patrick Schloemer
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- Prabhakar Viswanathan
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- Carolyn S. P. Lam
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- Faiez Zannad
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- Peter Rossing
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- Bertram Pitt
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- Rajiv Agarwal
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- John J. V. McMurray
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- Scott D. Solomon
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Correspondence to Scott D. Solomon.
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Vaduganathan, M., Filippatos, G., Claggett, B.L. et al. Finerenone in Heart Failure and Chronic Kidney Disease with Type 2 Diabetes: the FINE-HEART pooled analysis of cardiovascular, kidney, and mortality outcomes. Nat Med (2024). https://doi.org/10.1038/s41591-024-03264-4
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DOI: https://doi.org/10.1038/s41591-024-03264-4