Efficacy of finerenone in patients with type 2 diabetes, chronic kidney disease and altered markers of liver steatosis and fibrosis: A FIDELITY subgroup analysis.
In the FIDELITY pooled analysis of 13,026 patients with type 2 diabetes and chronic kidney disease, finerenone delivered consistent kidney protection and cardiovascular benefit regardless of liver steatosis or fibrosis status, with the largest cardiovascular reductions seen in patients carrying the highest FIB-4 fibrosis scores.
Background
FIDELITY is a prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials. This subgroup analysis stratified the 13,026 participants by markers of liver disease — high risk of steatosis (hepatic steatosis index >36), elevated transaminases, and fibrosis (FIB-4 index scores >1.30, >2.67, and >3.25) — to test whether the cardiorenal benefits of finerenone held across liver-risk groups.
Key findings
Finerenone consistently reduced the composite kidney outcome irrespective of altered liver tests, and its cardiovascular benefit was preserved or amplified at higher fibrosis burden, with cardiovascular composite risk reductions of 52%, 39%, and 24% across the FIB-4 strata (>3.25, >2.67, and >1.30, respectively). Liver enzymes (ALT, AST, and GGT) remained stable and comparable between the finerenone and placebo groups throughout the study.
Clinical implications
Finerenone has neutral effects on liver parameters and retains robust cardiorenal protection in patients with chronic kidney disease and type 2 diabetes who also show markers of liver steatosis or fibrosis — supporting its use in this common comorbid population, with the most profound cardiovascular benefit in those at highest fibrosis risk.
Category
Research
Source
Diabetes Obes Metab
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