Outcomes with Finerenone in Participants with Stage 4 CKD and Type 2 Diabetes

Author:

Sarafidis Pantelis1ORCID,Agarwal Rajiv2,Pitt Bertram3,Wanner Christoph4ORCID,Filippatos Gerasimos5,Boletis John6,Tuttle Katherine R.78ORCID,Ruilope Luis M.91011,Rossing Peter1213ORCID,Toto Robert14,Anker Stefan D.15,Liu Zhi-Hong16,Joseph Amer17,Ahlers Christiane18,Brinker Meike19,Lawatscheck Robert20,Bakris George21,

Affiliation:

1. Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece

2. Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana

3. Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan

4. Medizinische Klinik und Poliklinik 1, Schwerpunkt Nephrologie, Universitätsklinik Würzburg, Germany

5. National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece

6. Faculty of Medicine, Laiko General Hospital, University of Athens, Athens, Greece

7. Providence Medical Research Center, Providence Health Care, Spokane, Washington

8. Institute of Translational Health Sciences, Kidney Research Institute, and Nephrology Division, University of Washington, Seattle, Washington

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

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

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

12. Steno Diabetes Center Copenhagen, Herlev, Denmark

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

14. Department of Internal Medicine, University of Texas Southwestern Medicine, Dallas, Texas

15. 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

16. National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China

17. Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany

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

19. Cardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany

20. Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany

21. Department of Medicine, University of Chicago Medicine, Chicago, Illinois

Abstract

Background Patients with stage 4 CKD and type 2 diabetes have limited treatment options to reduce their persistent cardiovascular and kidney risk. In Finerenone in Chronic Kidney Disease and Type 2 Diabetes (FIDELITY), a prespecified pooled analysis of Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) and Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD), finerenone improved heart-kidney outcomes in participants with CKD and type 2 diabetes. Methods This FIDELITY subgroup analysis investigated the effects of finerenone in participants with stage 4 CKD (eGFR <30 ml/min per 1.73 m2). Efficacy outcomes included a cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and a kidney composite (kidney failure, sustained ≥57% decrease in eGFR from baseline, or kidney disease death). Results Of 13,023 participants, 890 (7%) had stage 4 CKD. The hazard ratio for risk of cardiovascular composite outcome with finerenone versus placebo was 0.78 (95% confidence interval, 0.57 to 1.07). The kidney composite outcome proportional hazards assumption was not met for the overall study period, with a protective effect only shown up to 2 years, after which the direction of association was inconsistent, and an observed loss of precision over time incurred on finerenone versus placebo risk differences. Nonetheless, albuminuria and rate of eGFR decline were consistently reduced with finerenone versus placebo. Adverse events were balanced between treatment arms. Hyperkalemia was the most common adverse event reported (stage 4 CKD: 26% and 13% for finerenone versus placebo, respectively); however, the incidence of hyperkalemia leading to permanent discontinuation was low (stage 4 CKD: 3% and 2% for finerenone versus placebo, respectively). Conclusions The cardiovascular benefits and safety profile of finerenone in participants with stage 4 CKD were consistent with the overall FIDELITY population; this was also the case for albuminuria and the rate of eGFR decline. The effects on the composite kidney outcome were not consistent over time.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Transplantation,Nephrology,Critical Care and Intensive Care Medicine,Epidemiology

Reference26 articles.

1. KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease;Kidney Int.,2020

2. Chronic kidney disease and risk management: standards of medical care in diabetes—2022;Diabetes Care.,2022

3. Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention;Gansevoort;Lancet.,2013

4. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy;Perkovic;N Engl J Med.,2019

5. Dapagliflozin in patients with chronic kidney disease;Heerspink;N Engl J Med.,2020

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