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Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes
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 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 .
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Mineralocorticoid receptor antagonists ameliorate the progression of CKD.
“Leptin is an important determinant of the decline in eGFR in the general population, and mineralocorticoid receptor antagonists ameliorate the progression of CKD23,27.”
From Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial (2025) · cites this paper as [27]
The Results and Discussion (page unavailable) report that finerenone, a mineralocorticoid receptor antagonist, reduced a kidney composite outcome by about 20%, with benefits driven by trials in people with CKD and type 2 diabetes. This supports a benefit for finerenone in that population, but the paper does not establish that mineralocorticoid receptor antagonists as a class slow CKD progression generally. (LLM, conf=0.87)
Experimental — accuracy not yet measuredLeptin is an important determinant of the decline in eGFR in the general population.
“Leptin is an important determinant of the decline in eGFR in the general population, and mineralocorticoid receptor antagonists ameliorate the progression of CKD23,27.”
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Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes
Bakris, G. L., Agarwal, R., Anker, S. D., Pitt, B., Ruilope, L. M., Rossing, P., Kolkhof, P., Nowack, C., Schloemer, P., Joseph, A., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2025845 · Cited by 2,935 · cited 7×
“A previous pooled analysis of the CKD with T2D trials showed that finerenone reduced major adverse cardiovascular events by 14% and a kidney composite outcome by 22% but remained underpowered in the evaluation of mortality outcomes 18 .”
InfluentialSelf-citationCardiovascular-kidney-metabolic health: a presidential advisory from the American Heart Association
Ndumele, C. E., Rangaswami, J., Chow, S. L., Neeland, I. J., Tuttle, K. R., Khan, S. S., Coresh, J., Mathew, R. O., Baker-Smith, C. M., Carnethon, M. R., et al. (2023) · Circulation · doi:10.1161/cir.0000000000001184 · Cited by 2,208 · cited 1×
“This cardiovascular-kidney-metabolic (CKM) overlap is increasingly recognized, and there is potential for individual therapies to simultaneously improve multiple adjacent disease states 4 .”
Cardiovascular events with finerenone in kidney disease and type 2 diabetes
Pitt, B., Filippatos, G., Agarwal, R., Anker, S. D., Bakris, G. L., Rossing, P., Joseph, A., Kolkhof, P., Nowack, C., Schloemer, P., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2110956 · Cited by 1,814
Self-citation2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes.
Marx, N., Federici, M., Schütt, K., Müller-Wieland, D., Ajjan, R. A., Antunes, M. J., Christodorescu, R. M., Crawford, C., Di Angelantonio, E., Eliasson, B., et al. (2023) · European Heart Journal · doi:10.1093/eurheartj/ehad192 · Cited by 1,642
Self-citationAgarwal, R., Filippatos, G., Pitt, B., Anker, S. D., Rossing, P., Joseph, A., Kolkhof, P., Nowack, C., Gebel, M., Ruilope, L. M., et al. (2022) · European Heart Journal · doi:10.1093/eurheartj/ehab777 · Cited by 1,317
Self-citationFinerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
Solomon, S. D., McMurray, J. J. V., Vaduganathan, M., Claggett, B., Jhund, P. S., Desai, A. S., Henderson, A. D., Lam, C. S. P., Pitt, B., Senni, M., et al. (2024) · New England Journal of Medicine · doi:10.1056/nejmoa2407107 · Cited by 893
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Cited by
Sorted by citations
Borlaug, B. A., Zile, M. R., Kramer, C. M., Baum, S. J., Hurt, K., Litwin, S. E., Murakami, M., Ou, Y., Upadhyay, N., & Packer, M. (2025) · Nature Medicine · doi:10.1038/s41591-024-03374-z · Cited by 166
Ndumele, C. E., Rodriguez, F., Dixon, D. L., Khan, S. S., Mukherjee, D., Bajaj, M., Bangalore, S., Bozkurt, B., Breathett, K., Clarke, S. L., et al. (2026) · JACC · doi:10.1016/j.jacc.2026.03.056 · Cited by 90
Metadata
- Authors
- Vaduganathan, M., Filippatos, G., Claggett, B. L., Desai, A. S., Jhund, P. S., Henderson, A., Brinker, M., Kolkhof, P., Schloemer, P., Lay-Flurrie, J., Viswanathan, P., Lam, C. S. P., Senni, M., Shah, S. J., Voors, A. A., Zannad, F., Rossing, P., Ruilope, L. M., Anker, S. D., Pitt, B., Agarwal, R., McMurray, J. J. V., & Solomon, S. D.
- Venue
- Nature Medicine
- Published
- 2024-09-01
- Volume
- 30
- Issue
- 12
- Pages
- 3758-3764
- ISSN
- 1078-8956
- 1546-170X
- PMC
- PMC11645272
- Cited by
- 158
- References
- 7
- Language
- en
- Update notices
- correction (2024-10-28)
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