Effect of Finerenone on Morbidity and Mortality in CKD

John W Ostrominski; Gerasimos Filippatos; Brian L Claggett; Zi Michael Miao; Akshay S Desai; Pardeep S Jhund; Alasdair Henderson; Katja Rohwedder; Meike D Brinker; Andrea Scalise; Patrick Schloemer; Carolyn S P Lam; Michele Senni; Sanjiv J Shah; Adriaan A Voors; Faiez Zannad; Peter Rossing; Luis M Ruilope; Stefan D Anker; Bertram Pitt; Rajiv Agarwal; John J V McMurray; Scott D Solomon; Muthiah Vaduganathan

doi:10.1681/ASN.0000000823

Effect of Finerenone on Morbidity and Mortality in CKD

John W Ostrominski, Gerasimos Filippatos, Brian L Claggett, Zi Michael Miao, Akshay S Desai, Pardeep S Jhund, Alasdair Henderson, Katja Rohwedder, Meike D Brinker, Andrea Scalise, Patrick Schloemer, Carolyn S P Lam, Michele Senni, Sanjiv J Shah, Adriaan A Voors, Faiez Zannad, Peter Rossing, Luis M Ruilope, Stefan D Anker, Bertram PittRajiv Agarwal, John J V McMurray, Scott D Solomon, Muthiah Vaduganathan^*

^*Corresponding author af dette arbejde

Steno Diabetes Center Copenhagen

Abstract

BACKGROUND: Finerenone has been shown to reduce cardiovascular and kidney events in individuals with chronic kidney disease (CKD) and type 2 diabetes. Pooling data from all completed outcomes trials evaluating finerenone to date may enhance understanding of its effects on morbidity and mortality in this high-risk population.

METHODS: In this prespecified participant-level pooled analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials (FINE-HEART), FINEARTS-HF trial participants with type 2 diabetes, CKD, and albuminuria were pooled with the persons enrolled in FIDELIO-DKD and FIGARO-DKD. Treatment effects of finerenone versus placebo on cardiovascular events, composite kidney outcomes, all-cause hospitalization, and mortality were evaluated using Cox proportional hazards regression models, stratified by trial and geographic region.

RESULTS: Among 18,991 pooled trial participants, 14,180 (mean age, 65±10 years; 31% female; mean eGFR, 58±22 mL/min/1.73 m2; median UACR, 478 [IQR, 167-1103] mg/g) were included in the analysis. Finerenone reduced cardiovascular death or heart failure hospitalization (hazard ratio, 0.83; 95% CI, 0.75-0.93; P=0.001) compared with placebo, without evidence of heterogeneity according to baseline eGFR (Pinteraction=0.18), UACR (Pinteraction=0.60), or HbA1c (Pinteraction=0.51). Finerenone additionally appeared to reduce cardiovascular death, heart failure hospitalization, major adverse cardiovascular events, new-onset atrial fibrillation, and the composite kidney outcome. Benefits on the composite kidney outcome appeared greater with higher baseline UACR (Pinteraction=0.04). In sensitivity analyses evaluating a broader range of participants with CKD, finerenone appeared to consistently reduce cardiovascular death or heart failure hospitalization irrespective of 1) UACR (Pinteraction=0.22) when FINEARTS-HF participants with type 2 diabetes and at least moderate-risk CKD were included; and 2) HbA1c (Pinteraction=0.59) when FINEARTS-HF participants with albuminuric CKD but without diabetes were included. Serious adverse events were less common with finerenone versus placebo (34% vs. 36%), but hyperkalemia-related permanent treatment discontinuations were more common (2% vs. 1%).

CONCLUSIONS: In this prespecified FINE-HEART analysis, finerenone reduced cardiovascular, kidney, and mortality events across a wide spectrum of CKD in persons with type 2 diabetes.

Originalsprog	Engelsk
Tidsskrift	Journal of the American Society of Nephrology
ISSN	1046-6673
DOI	https://doi.org/10.1681/ASN.0000000823
Status	Udgivet - 12 sep. 2025

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Ostrominski, J. W., Filippatos, G., Claggett, B. L., Miao, Z. M., Desai, A. S., Jhund, P. S., Henderson, A., Rohwedder, K., Brinker, M. D., Scalise, A., Schloemer, P., Lam, C. S. P., Senni, M., Shah, S. J., Voors, A. A., Zannad, F., Rossing, P., Ruilope, L. M., Anker, S. D., ... Vaduganathan, M. (2025). Effect of Finerenone on Morbidity and Mortality in CKD. Journal of the American Society of Nephrology. https://doi.org/10.1681/ASN.0000000823

Ostrominski, JW, Filippatos, G, Claggett, BL, Miao, ZM, Desai, AS, Jhund, PS, Henderson, A, Rohwedder, K, Brinker, MD, Scalise, A, Schloemer, P, Lam, CSP, Senni, M, Shah, SJ, Voors, AA, Zannad, F, Rossing, P, Ruilope, LM, Anker, SD, Pitt, B, Agarwal, R, McMurray, JJV, Solomon, SD & Vaduganathan, M 2025, 'Effect of Finerenone on Morbidity and Mortality in CKD', Journal of the American Society of Nephrology. https://doi.org/10.1681/ASN.0000000823

@article{112836d0c5424160b3592a6d0ce93493,

title = "Effect of Finerenone on Morbidity and Mortality in CKD",

abstract = "BACKGROUND: Finerenone has been shown to reduce cardiovascular and kidney events in individuals with chronic kidney disease (CKD) and type 2 diabetes. Pooling data from all completed outcomes trials evaluating finerenone to date may enhance understanding of its effects on morbidity and mortality in this high-risk population.METHODS: In this prespecified participant-level pooled analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials (FINE-HEART), FINEARTS-HF trial participants with type 2 diabetes, CKD, and albuminuria were pooled with the persons enrolled in FIDELIO-DKD and FIGARO-DKD. Treatment effects of finerenone versus placebo on cardiovascular events, composite kidney outcomes, all-cause hospitalization, and mortality were evaluated using Cox proportional hazards regression models, stratified by trial and geographic region.RESULTS: Among 18,991 pooled trial participants, 14,180 (mean age, 65±10 years; 31% female; mean eGFR, 58±22 mL/min/1.73 m2; median UACR, 478 [IQR, 167-1103] mg/g) were included in the analysis. Finerenone reduced cardiovascular death or heart failure hospitalization (hazard ratio, 0.83; 95% CI, 0.75-0.93; P=0.001) compared with placebo, without evidence of heterogeneity according to baseline eGFR (Pinteraction=0.18), UACR (Pinteraction=0.60), or HbA1c (Pinteraction=0.51). Finerenone additionally appeared to reduce cardiovascular death, heart failure hospitalization, major adverse cardiovascular events, new-onset atrial fibrillation, and the composite kidney outcome. Benefits on the composite kidney outcome appeared greater with higher baseline UACR (Pinteraction=0.04). In sensitivity analyses evaluating a broader range of participants with CKD, finerenone appeared to consistently reduce cardiovascular death or heart failure hospitalization irrespective of 1) UACR (Pinteraction=0.22) when FINEARTS-HF participants with type 2 diabetes and at least moderate-risk CKD were included; and 2) HbA1c (Pinteraction=0.59) when FINEARTS-HF participants with albuminuric CKD but without diabetes were included. Serious adverse events were less common with finerenone versus placebo (34% vs. 36%), but hyperkalemia-related permanent treatment discontinuations were more common (2% vs. 1%).CONCLUSIONS: In this prespecified FINE-HEART analysis, finerenone reduced cardiovascular, kidney, and mortality events across a wide spectrum of CKD in persons with type 2 diabetes.",

author = "Ostrominski, {John W} and Gerasimos Filippatos and Claggett, {Brian L} and Miao, {Zi Michael} and Desai, {Akshay S} and Jhund, {Pardeep S} and Alasdair Henderson and Katja Rohwedder and Brinker, {Meike D} and Andrea Scalise and Patrick Schloemer and Lam, {Carolyn S P} and Michele Senni and Shah, {Sanjiv J} and Voors, {Adriaan A} and Faiez Zannad and Peter Rossing and Ruilope, {Luis M} and Anker, {Stefan D} and Bertram Pitt and Rajiv Agarwal and McMurray, {John J V} and Solomon, {Scott D} and Muthiah Vaduganathan",

note = "Copyright {\textcopyright} 2025 by the American Society of Nephrology.",

year = "2025",

month = sep,

day = "12",

doi = "10.1681/ASN.0000000823",

language = "English",

journal = "Journal of the American Society of Nephrology",

issn = "1046-6673",

publisher = "The American Society of Nephrology",

}

TY - JOUR

T1 - Effect of Finerenone on Morbidity and Mortality in CKD

AU - Ostrominski, John W

AU - Filippatos, Gerasimos

AU - Claggett, Brian L

AU - Miao, Zi Michael

AU - Desai, Akshay S

AU - Jhund, Pardeep S

AU - Henderson, Alasdair

AU - Rohwedder, Katja

AU - Brinker, Meike D

AU - Scalise, Andrea

AU - Schloemer, Patrick

AU - Lam, Carolyn S P

AU - Senni, Michele

AU - Shah, Sanjiv J

AU - Voors, Adriaan A

AU - Zannad, Faiez

AU - Rossing, Peter

AU - Ruilope, Luis M

AU - Anker, Stefan D

AU - Pitt, Bertram

AU - Agarwal, Rajiv

AU - McMurray, John J V

AU - Solomon, Scott D

AU - Vaduganathan, Muthiah

PY - 2025/9/12

Y1 - 2025/9/12

N2 - BACKGROUND: Finerenone has been shown to reduce cardiovascular and kidney events in individuals with chronic kidney disease (CKD) and type 2 diabetes. Pooling data from all completed outcomes trials evaluating finerenone to date may enhance understanding of its effects on morbidity and mortality in this high-risk population.METHODS: In this prespecified participant-level pooled analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials (FINE-HEART), FINEARTS-HF trial participants with type 2 diabetes, CKD, and albuminuria were pooled with the persons enrolled in FIDELIO-DKD and FIGARO-DKD. Treatment effects of finerenone versus placebo on cardiovascular events, composite kidney outcomes, all-cause hospitalization, and mortality were evaluated using Cox proportional hazards regression models, stratified by trial and geographic region.RESULTS: Among 18,991 pooled trial participants, 14,180 (mean age, 65±10 years; 31% female; mean eGFR, 58±22 mL/min/1.73 m2; median UACR, 478 [IQR, 167-1103] mg/g) were included in the analysis. Finerenone reduced cardiovascular death or heart failure hospitalization (hazard ratio, 0.83; 95% CI, 0.75-0.93; P=0.001) compared with placebo, without evidence of heterogeneity according to baseline eGFR (Pinteraction=0.18), UACR (Pinteraction=0.60), or HbA1c (Pinteraction=0.51). Finerenone additionally appeared to reduce cardiovascular death, heart failure hospitalization, major adverse cardiovascular events, new-onset atrial fibrillation, and the composite kidney outcome. Benefits on the composite kidney outcome appeared greater with higher baseline UACR (Pinteraction=0.04). In sensitivity analyses evaluating a broader range of participants with CKD, finerenone appeared to consistently reduce cardiovascular death or heart failure hospitalization irrespective of 1) UACR (Pinteraction=0.22) when FINEARTS-HF participants with type 2 diabetes and at least moderate-risk CKD were included; and 2) HbA1c (Pinteraction=0.59) when FINEARTS-HF participants with albuminuric CKD but without diabetes were included. Serious adverse events were less common with finerenone versus placebo (34% vs. 36%), but hyperkalemia-related permanent treatment discontinuations were more common (2% vs. 1%).CONCLUSIONS: In this prespecified FINE-HEART analysis, finerenone reduced cardiovascular, kidney, and mortality events across a wide spectrum of CKD in persons with type 2 diabetes.

AB - BACKGROUND: Finerenone has been shown to reduce cardiovascular and kidney events in individuals with chronic kidney disease (CKD) and type 2 diabetes. Pooling data from all completed outcomes trials evaluating finerenone to date may enhance understanding of its effects on morbidity and mortality in this high-risk population.METHODS: In this prespecified participant-level pooled analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials (FINE-HEART), FINEARTS-HF trial participants with type 2 diabetes, CKD, and albuminuria were pooled with the persons enrolled in FIDELIO-DKD and FIGARO-DKD. Treatment effects of finerenone versus placebo on cardiovascular events, composite kidney outcomes, all-cause hospitalization, and mortality were evaluated using Cox proportional hazards regression models, stratified by trial and geographic region.RESULTS: Among 18,991 pooled trial participants, 14,180 (mean age, 65±10 years; 31% female; mean eGFR, 58±22 mL/min/1.73 m2; median UACR, 478 [IQR, 167-1103] mg/g) were included in the analysis. Finerenone reduced cardiovascular death or heart failure hospitalization (hazard ratio, 0.83; 95% CI, 0.75-0.93; P=0.001) compared with placebo, without evidence of heterogeneity according to baseline eGFR (Pinteraction=0.18), UACR (Pinteraction=0.60), or HbA1c (Pinteraction=0.51). Finerenone additionally appeared to reduce cardiovascular death, heart failure hospitalization, major adverse cardiovascular events, new-onset atrial fibrillation, and the composite kidney outcome. Benefits on the composite kidney outcome appeared greater with higher baseline UACR (Pinteraction=0.04). In sensitivity analyses evaluating a broader range of participants with CKD, finerenone appeared to consistently reduce cardiovascular death or heart failure hospitalization irrespective of 1) UACR (Pinteraction=0.22) when FINEARTS-HF participants with type 2 diabetes and at least moderate-risk CKD were included; and 2) HbA1c (Pinteraction=0.59) when FINEARTS-HF participants with albuminuric CKD but without diabetes were included. Serious adverse events were less common with finerenone versus placebo (34% vs. 36%), but hyperkalemia-related permanent treatment discontinuations were more common (2% vs. 1%).CONCLUSIONS: In this prespecified FINE-HEART analysis, finerenone reduced cardiovascular, kidney, and mortality events across a wide spectrum of CKD in persons with type 2 diabetes.

U2 - 10.1681/ASN.0000000823

DO - 10.1681/ASN.0000000823

M3 - Journal article

C2 - 40938666

SN - 1046-6673

JO - Journal of the American Society of Nephrology

JF - Journal of the American Society of Nephrology

ER -

Effect of Finerenone on Morbidity and Mortality in CKD

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