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Abstract: SA-PO274

Cardiorenal Outcomes With Finerenone in Asian Patients With CKD and Type 2 Diabetes: Post Hoc Analysis From FIDELIO-DKD

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Koya, Daisuke, Department of Diabetology and Endocrinology, and the Division of Anticipatory Molecular Food Science, Kanazawa Medical University, Kanazawa, Japan
  • Anker, Stefan D., 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
  • Ruilope, Luis M., Cardiorenal translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Lee, Byung-Wan, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Korea (the Republic of)
  • Lee, Chien-Te, Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital, College of Medicine, Chang-Gung University, Nanjing, Taiwan
  • Liu, Zhi Hong, National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
  • Scott, Charlie, Data Science and Analytics, Bayer PLC, Reading, United Kingdom
  • Kolkhof, Peter, Research and Development, Cardiovascular Precision Medicines, Bayer AG, Wuppertal, Germany
  • Lawatscheck, Robert, Clinical Research, Bayer AG, Berlin, Germany
  • Wang, Lili, Bayer Pte Ltd, Singapore, Singapore
  • Joseph, Amer, Research and Development, Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany
  • Pitt, Bertram, Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, United States

Group or Team Name

  • On behalf of the FIDELIO-DKD Investigators
Background

In FIDELIO-DKD, finerenone significantly improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). A post hoc analysis of FIDELIO-DKD data was conducted to explore the cardiorenal effects of finerenone in patients from the Asian region.

Methods

In FIDELIO-DKD (NCT02540993), 5674 patients were randomized to receive finerenone or placebo, of whom 1327 were from 10 Asian countries and territories. Eligible patients had T2D, and either urine albumin-to-creatinine ratio (UACR) ≥30 to <300 mg/g and estimated glomerular filtration rate (eGFR) ≥25 to <60 mL/min/1.73 m2, or UACR ≥300 to ≤5000 mg/g and eGFR ≥25 to <75 mL/min/1.73 m2, and were treated with optimized renin–angiotensin system blockade. The primary efficacy outcome was a kidney composite outcome (time to kidney failure, death from renal causes, and sustained decrease of ≥40% in eGFR from baseline). Secondary efficacy outcomes included both kidney (time to kidney failure, death from renal causes, and sustained decrease of ≥57% in eGFR from baseline) and cardiovascular (CV; time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) composite outcomes.

Results

In the Asian subgroup, 665/1327 (50%) patients received finerenone. The finerenone cohort of the Asian subgroup showed reduced ≥40% and ≥57% eGFR kidney composite outcomes and CV composite outcome vs the placebo group (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.56–0.87; HR=0.73, 95% CI 0.55–0.97; and HR=0.85, 95% CI 0.59–1.21, respectively). No apparent differences were observed between the Asian subgroup and patients from the rest of the world for these outcomes (HR=0.88, 95% CI 0.77–1.02 [Pinteraction=0.09]; HR=0.78; 95% CI 0.64–0.95 [Pinteraction=0.71]; and HR=0.86, 95% CI 0.74–1.00 [Pinteraction=0.95], respectively). Finerenone demonstrated similar safety across subgroups.

Conclusion

The beneficial effect of finerenone on cardiorenal outcomes in the Asian population are comparable to the overall results observed in FIDELIO-DKD.

Funding

  • Commercial Support – Bayer AG