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

作者：Nikolaos Perakakis, Stefan R. Bornstein, Andreas L. Birkenfeld, Andreas Linkermann, Münevver Demir, Stefan D. Anker, Gerasimos Filippatos, Bertram Pitt, Peter Rossing, Luís M. Ruilope, Peter Kolkhof, Robert Lawatscheck, Charlie Scott, George L. Bakris, FIDELIO‐DKD and FIGARO‐DKD investigators · 发表于：Diabetes Obesity and Metabolism · 年份：2023 · DOI：10.1111/dom.15305 · 被引用次数：15 · 研究领域：Liver Disease and Transplantation、Hormonal Regulation and Hypertension、Liver Disease Diagnosis and Treatment

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 inte...