Kidney outcomes with finerenone: an analysis from the FIGARO-DKD study

Author:

Ruilope Luis M123,Pitt Bertram4,Anker Stefan D5,Rossing Peter67ORCID,Kovesdy Csaba P8ORCID,Pecoits-Filho Roberto910,Pergola Pablo11,Joseph Amer12,Lage Andrea13,Mentenich Nicole14,Scheerer Markus F15,Bakris George L16

Affiliation:

1. Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12 , Madrid , Spain

2. CIBER-CV, Hospital Universitario 12 de Octubre , Madrid , Spain

3. Faculty of Sport Sciences, European University of Madrid , Madrid , Spain

4. Department of Medicine, University of Michigan School of Medicine , Ann Arbor, MI , USA

5. Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies , German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin , Germany

6. Steno Diabetes Center Copenhagen , Gentofte , Denmark

7. Department of Clinical Medicine, University of Copenhagen , Copenhagen, Denmark

8. Division of Nephrology, Department of Medicine, University of Tennessee Health Science Center , Memphis , TN, USA

9. Arbor Research Collaborative for Health , Ann Arbor, MI , USA

10. School of Medicine, Pontifícia Universidade Católica do Paraná , Curitiba , Brazil

11. Renal Associates , PA, San Antonio, TX , USA

12. Research and Development, Cardiology and Nephrology Clinical Development , Bayer AG, Berlin , Germany

13. Cardiology and Nephrology Clinical Development , Bayer SA, São Paulo , Brazil

14. Statistics and Data Insights, Bayer AG , Wuppertal , Germany

15. Global Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG , Berlin , Germany

16. Department of Medicine, University of Chicago Medicine , Chicago, IL , USA

Abstract

ABSTRACT Background In FIGARO-DKD, finerenone reduced the risk of cardiovascular events in patients with type 2 diabetes (T2D) and stage 1–4 chronic kidney disease (CKD). In FIDELIO-DKD, finerenone improved kidney and cardiovascular outcomes in patients with advanced CKD. This analysis further explores kidney outcomes in FIGARO-DKD. Methods FIGARO-DKD (NCT02545049) included patients with urine albumin-to-creatinine ratio (UACR) 30–<300 mg/g and estimated glomerular filtration rate (eGFR) 25–90 mL/min/1.73 m2 or UACR 300–5000 mg/g and eGFR ≥60 mL/min/1.73 m2. Outcomes included two composite kidney endpoints, a composite of ≥40% decrease in eGFR from baseline sustained over ≥4 weeks, kidney failure or renal death, and a composite of ≥57% decrease in eGFR from baseline sustained over ≥4 weeks, kidney failure or renal death. Changes in albuminuria and eGFR slope were also analyzed. Kidney and CV outcomes were evaluated by baseline UACR. Results A lower incidence rate for the eGFR ≥40% kidney composite endpoint was observed with finerenone compared with placebo, but the between-group difference was not significant [hazard ratio (HR) = 0.87; 95% confidence interval (CI): 0.76–1.01; P = .069]. A greater treatment effect was observed on the eGFR ≥57% kidney composite endpoint (HR = 0.77; 95% CI: 0.60–0.99; P = 0.041) with a 36% relative risk reduction for end-stage kidney disease. A larger magnitude of effect on kidney outcomes was observed with finerenone versus placebo for patients with severely increased albuminuria than with moderately increased albuminuria. Improvements in UACR, eGFR slope and cardiovascular risk were evident in both subgroups with finerenone. Conclusions The present analyses suggest that finerenone protects against kidney disease progression and cardiovascular events in patients with T2D and early- or late-stage CKD.

Funder

Bayer AG

FIGARO-DKD

Publisher

Oxford University Press (OUP)

Subject

Transplantation,Nephrology

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