Type 2 & other diabetes

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 MetabPublished Secondary analysis of the FIDELITY pooled analysis

Authors' conclusion

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.

Study context

Population
Patients with CKD and T2D, stratified by liver steatosis risk (hepatic steatosis index >36), elevated transaminases (alanine transaminase (ALT) >33 IU/L males, >25 IU/L females) and FIB-4 index >3.25, >2.67 and >1.30
Participants
13,026 patients
Comparison
Finerenone vs placebo
Outcome
Composite CV outcome by FIB-4 subgroup
Methodological detailspost hoc, subgroup analysis
  • Post hoc
  • Subgroup analysis

Pooled result

As reported in the abstract

Risk reduction with finerenone vs placebo, FIB-4 >3.25 (P for interaction = .01)

52%

Risk reduction with finerenone vs placebo, FIB-4 >2.67 (P for interaction = .13)

39%

Risk reduction with finerenone vs placebo, FIB-4 >1.30 (P for interaction = .03)

24%

Safety

Liver enzymes (ALT, AST, GGT)

ALT, AST and GGT levels consistent between treatment groups and stable throughout

Original publication

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. Published 10 October 2023. doi:10.1111/dom.15305

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