Efficacy of finerenone in patients with type 2 diabetes, chronic kidney disease and altered markers of liver steatosis and fibrosis: A <scp>FIDELITY</scp> subgroup analysis-Reference-Cited by-同舟云学术

Efficacy of finerenone in patients with type 2 diabetes, chronic kidney disease and altered markers of liver steatosis and fibrosis: A FIDELITY subgroup analysis

Published:2023-10-10 Issue:1 Volume:26 Page:191-200
ISSN:1462-8902
Container-title:Diabetes, Obesity and Metabolism
language:en
Short-container-title:Diabetes Obesity Metabolism

Author:

Perakakis Nikolaos¹²³,Bornstein Stefan R.¹²³⁴,Birkenfeld Andreas L.³⁴⁵⁶^ORCID,Linkermann Andreas¹⁷,Demir Münevver⁸,Anker Stefan D.⁹¹⁰,Filippatos Gerasimos¹¹,Pitt Bertram¹²,Rossing Peter¹³¹⁴^ORCID,Ruilope Luis M.¹⁵¹⁶¹⁷,Kolkhof Peter¹⁸,Lawatscheck Robert¹⁹,Scott Charlie²⁰,Bakris George L.²¹^ORCID,

Affiliation:

1. University Study Center for Metabolic Diseases, Department of Internal Medicine III Carl Gustav Carus University Clinic, TU Dresden Dresden Germany

2. University Hospital and Faculty of Medicine, TU Dresden, Dresden, Paul Langerhans Institute Dresden (PLID), Helmholtz Center Munich Dresden Germany

3. Neuherberg, German Center for Diabetes Research (DZD e.V.) Neuherberg Germany

4. Diabetes and Nutritional Sciences, King's College London London UK

5. Department of Diabetology, Endocrinology and Nephrology University Clinic Tübingen Germany

6. Institute for Diabetes Research and Metabolic Diseases, Helmholtz Center Munich University of Tübingen Tübingen Germany

7. Division of Nephrology, Department of Medicine, Albert Einstein College of Medicine Bronx New York USA

8. Hepatology Outpatient Clinic Charité Universitätsmedizin Berlin Germany

9. 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

10. Institute of Heart Diseases Wrocław Medical University Wrocław Poland

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

12. Department of Medicine University of Michigan School of Medicine Ann Arbor Michigan USA

13. Steno Diabetes Center Copenhagen Herlev Denmark

14. Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

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

16. CIBER‐CV Hospital Universitario 12 de Octubre Madrid Spain

17. Faculty of Sport Sciences European University of Madrid Madrid Spain

18. Research and Development, Preclinical Research Cardiovascular Wuppertal Germany

19. Clinical Research Berlin Germany

20. Data science and analytics Bayer PLC Reading UK

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

Abstract

AbstractAimInvestigating the effect of finerenone on liver function, cardiovascular and kidney composite outcomes in patients with chronic kidney disease and type 2 diabetes, stratified by their risk of liver steatosis, inflammation and fibrosis.Materials and MethodsPost hoc analysis stratified patients (N = 13 026) by liver fibrosis and enzymes: high risk of steatosis (hepatic steatosis index >36); elevated transaminases [alanine transaminase (ALT) >33 (males) and >25 IU/L (females)]; and fibrosis‐4 (FIB‐4) index scores >3.25, >2.67 and >1.30. Liver enzymes were assessed by changes in ALT, aspartate aminotransferase and gamma‐glutamyl transferase. Composite kidney outcome was defined as onset of kidney failure, sustained estimated glomerular filtration rate decline ≥57% from baseline over ≥4 weeks or kidney death. Composite cardiovascular outcome was defined as cardiovascular death, non‐fatal myocardial infarction, non‐fatal stroke or hospitalization for heart failure.ResultsALT, aspartate aminotransferase and gamma‐glutamyl transferase levels were consistent between treatment groups and remained stable throughout. Finerenone consistently reduced the risk of composite kidney outcome, irrespective of altered liver tests. Higher FIB‐4 score was associated with higher incidence rates of composite cardiovascular outcome. Finerenone reduced the risk of composite cardiovascular outcome versus placebo in FIB‐4 subgroups by 52% (>3.25), 39% (>2.67) and 24% (>1.30) (p values for interaction = .01, .13 and .03, respectively).ConclusionsFinerenone has neutral effects on liver parameters in patients with chronic kidney disease and type 2 diabetes. Finerenone showed robust and consistent kidney benefits in patients with altered liver tests, and profound cardiovascular benefits even in patients with higher FIB‐4 scores who were at high risk of developing cardiovascular complications.

Funder

Bayer

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

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