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Perakakis, N. ; Bornstein, S.R. ; Birkenfeld, A.L. ; Linkermann, A.* ; Demir, M.* ; Anker, S.D.* ; Filippatos, G.* ; Pitt, B.* ; Rossing, P.* ; Ruilope, L.M.* ; Kolkhof, P.* ; Lawatscheck, R.* ; Scott, C.* ; Bakris, G.L.*

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

Diabetes Obes. Metab. 26, 191-200 (2024)
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AIM: Investigating 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 METHODS: Post 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. RESULTS: ALT, 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). CONCLUSIONS: Finerenone 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.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Clinical Trial ; Diabetes Complications ; Liver ; Type 2 Diabetes; Base-line Characteristics; Mineralocorticoid Receptor; Cardiovascular Events; Risk; Spironolactone; Antagonist; Index; Protects; Design; Ratio
Language english
Publication Year 2024
Prepublished in Year 2023
HGF-reported in Year 2023
ISSN (print) / ISBN 1462-8902
e-ISSN 1463-1326
Journal Diabetes, Obesity and Metabolism
Quellenangaben Volume: 26, Issue: 1, Pages: 191-200 Article Number: , Supplement: ,
Publisher Wiley
Publishing Place 111 River St, Hoboken 07030-5774, Nj Usa
Reviewing status Peer reviewed
Institute(s) Institute of Pancreatic Islet Research (IPI)
Institute of Diabetes Research and Metabolic Diseases (IDM)
POF-Topic(s) 90000 - German Center for Diabetes Research
Research field(s) Helmholtz Diabetes Center
PSP Element(s) G-502600-012
G-502600-007
G-502400-001
Grants Bayer AG, Berlin, Germany
DOI 10.1111/dom.15305
WOS ID 001081555600001
Scopus ID 85173735791
PubMed ID 37814928
Erfassungsdatum 2023-11-28
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