Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes
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 cardiovascular-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 cardiovascular-kidney-metabolic syndrome, we summarize the efficacy and safety of finerenone on cardiovascular, kidney and mortality outcomes in this pre-specified participant-level pooled analysis. The three trials included 18,991 participants (mean age 67 ± 10 years; 35% women). During 2.9 years of median follow-up, the primary outcome of cardiovascular death occurred in 421 (4.4%) participants assigned to finerenone and 471 (5.0%) participants assigned to placebo (hazard ratio (HR): 0.89; 95% confidence interval (CI): 0.78-1.01; P = 0.076). Death from any cause occurred in 1,042 (11.0%) participants in the finerenone arm and in 1,136 (12.0%) participants in the placebo arm (HR: 0.91; 95% CI: 0.84-0.99; P = 0.027). Finerenone further reduced the risk of hospitalization from heart failure (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 in this pooled analysis the reduction in cardiovascular death was not statistically significant, finerenone reduced the risks for deaths of any cause, cardiovascular events and kidney outcomes. PROSPERO identifier: CRD42024570467 .
Authors
- Stefan D. Anker (ORCID: https://orcid.org/0000-0002-0805-8683)
- Sanjiv J. Shah (ORCID: https://orcid.org/0000-0002-5655-8201)
- Brian Lee Claggett (ORCID: https://orcid.org/0000-0002-4215-9218)
- Pardeep S. Jhund (ORCID: https://orcid.org/0000-0003-4306-5317)
- Gerasimos S Filippatos (ORCID: https://orcid.org/0000-0002-5640-0332)
- James Lay‐Flurrie
- John J.V. McMurray (ORCID: https://orcid.org/0000-0002-6317-3975)
- Alasdair Henderson (ORCID: https://orcid.org/0000-0002-8903-4906)
- Faiez M. Zannad (ORCID: https://orcid.org/0000-0001-7456-1570)
- Luís M. Ruilope (ORCID: https://orcid.org/0000-0001-6278-7951)
- Bertram Pitt (ORCID: https://orcid.org/0000-0001-5880-275X)
- Patrick Schloemer (ORCID: https://orcid.org/0009-0004-7787-5662)
- Peter Kolkhof (ORCID: https://orcid.org/0000-0003-3425-7528)
- Meike Brinker (ORCID: https://orcid.org/0000-0002-1560-9535)
- Scott David Solomon (ORCID: https://orcid.org/0000-0003-3698-9597)
- Michele Senni (ORCID: https://orcid.org/0000-0001-5502-7882)
- Muthiah Vaduganathan (ORCID: https://orcid.org/0000-0003-0885-1953)
- Carolyn S.P. Lam (ORCID: https://orcid.org/0000-0003-1903-0018)
- Adriaan A. Voors (ORCID: https://orcid.org/0000-0002-5417-4415)
- Peter R Rossing (ORCID: https://orcid.org/0000-0002-1531-4294)
- Rajiv Agarwal (ORCID: https://orcid.org/0000-0001-8355-7100)
- Akshay S. Desai
- Prabhakar Viswanathan
Institutions
- Northwestern University (US)
- University of Copenhagen (DK)
- Brigham and Women's Hospital (US)
- Steno Diabetes Centers (DK)
- Harvard University (US)
- National University of Singapore (SG)
- University of Groningen (NL)
- National and Kapodistrian University of Athens (GR)
- University of Michigan (US)
- Research Institute Hospital 12 de Octubre (ES)
- Ospedale Papa Giovanni XXIII (IT)
- National University Heart Centre Singapore (SG)
- National Heart Centre Singapore (SG)
- Indiana University School of Medicine
- Indiana University – Purdue University Indianapolis (US)
- University of Milano-Bicocca (IT)
- Bayer (Germany) (DE)
- Charité - Universitätsmedizin Berlin (DE)
- University of Glasgow (GB)
- Université de Lorraine (FR)
Publication Details
- Journal
- Nature Medicine
- Published
- 2024-09-01
- DOI
- https://doi.org/10.1038/s41591-024-03264-4
- Citations
- 101
- Primary Topic
- Hormonal Regulation and Hypertension
- Type
- article
- Field-Weighted Citation Impact
- 36.13
Funders
- Bayer