Perakaki, NikolaosBornstein, Stefan R.Birkenfeld, Andreas L.Linkermann, AndreasDemir, MünevverAnker, Stefan D.Filippatos, Gerasimos S.Pitt, BertramRossing, PeterRuilope Urioste, Luis MiguelEt al.2025-05-162025-05-162024Perakakis, 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., & FIDELIO‐DKD and FIGARO‐DKD investigators. (2024). 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, Obesity and Metabolism, 26(1), 191-200. https://doi.org/10.1111/dom.153051463-13261462-8902http://hdl.handle.net/11268/14624Aim 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.engAttribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/Enfermedades RenalesDiabetes Mellitus Tipo 2Ensayo Clínicojournal article10.1111/dom.15305open accessInvestigación médicaPatologíaTratamiento médicoGoal 3: Ensure healthy lives and promote well-being for all at all ages