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Kidney Week

Abstract: SA-PO476

ESKD-Free Survival Time in Patients with CKD and Type 2 Diabetes (TD2) in FIDELITY

Session Information

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Singh, Ajay K., Renal Division, Harvard Medical School, Harvard University, Boston, Massachusetts, United States
  • Anker, Stefan D., Department of Cardiology (CVK) of German Heart Center Charité; Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany
  • Filippatos, Gerasimos, National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece
  • Pitt, Bertram, Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, United States
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Ruilope, Luis M., Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain
  • Ahlers, Christiane, Statistics and Data Insights, Bayer AG, Wuppertal, Germany
  • Farag, Youssef MK, Cardiovascular and Renal United States Medical Affairs, Bayer U.S. LLC, Cambridge, Massachusetts, United States
  • Rohwedder, Katja, Medical Affairs, Bayer AG, Berlin, Germany
  • Roberts, Luke, Clinical Development, Bayer PLC, Reading, United Kingdom
  • Bakris, George L., Department of Medicine, University of Chicago Medicine, Chicago, Illinois, United States
Background

End-stage kidney disease (ESKD) is a major health and economic burden; patients with reduced quality of life are at high risk of cardiovascular mortality. Finerenone significantly reduced the risk of cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials. Here, we estimated the ESKD-free survival time of patients treated with finerenone vs placebo.

Methods

Patients with T2D and CKD (albuminuria and estimated glomerular filtration rate [eGFR] ≥25–90 mL/min/1.73 m2) and on optimized renin–angiotensin system (RAS) inhibition were randomized (1:1) to finerenone or placebo. To estimate the population-level effect of finerenone, the restricted mean survival time for ESKD after 4.5 years of treatment in FIDELITY was extrapolated to 6,425,196 US patients with T2D and CKD according to the US National Health and Nutrition Examination Survey. The cumulative incidence and treatment effects of finerenone vs placebo for time to eGFR <10 mL/min/1.73 m2 were also analyzed using a patient-based two-slope model extrapolated to 20 years.

Results

In FIDELITY, finerenone significantly reduced the risk of ESKD vs placebo (hazard ratio [HR]=0.80; 95% confidence interval [CI] 0.64–0.99; p=0.040). After 4.5 years of treatment with finerenone, the overall estimated time saved from ESKD for the US patient population vs placebo was 103,260 years (95% CI −3407 to 210,556). Using extrapolations based on 5000 Monte-Carlo simulations for the individual eGFR patient slopes, the cumulative incidence for time to eGFR <10 mL/min/1.73 m2 showed a risk difference between treatments of −4.5%, −7.6%, −6.7% and −5.6% for 5, 10, 15 and 20 years, respectively, corresponding to a number needed to treat of 22, 13, 15 and 18 patients for finerenone. Treatment effects of finerenone vs placebo for time to eGFR <10 mL/min/1.73 m2 showed a relative risk reduction of 21% (HR=0.79; 95% CI 0.76–0.82).

Conclusion

Treatment with finerenone and optimized RAS therapy was associated with a delay in time to ESKD in patients with CKD and T2D and may provide patient and healthcare cost-saving benefits.

Funding

  • Commercial Support – Bayer AG