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Published on: July 21, 2023
A retrospective cohort study on the impact of finerenone on the hepatic fibrosis indicator FIB-4
Bo An1, Fang Chen1, Wencheng An1
1Department of Endocrinology, Beijing Haidian Hospital, Beijing, China.
Objective:
This study aimed to evaluate the influence of finerenone, a novel nonsteroidal selective mineralocorticoid receptor antagonist (nsMRA), on the hepatic fibrosis indicator FIB-4, as well as its safety profile in hospitalized patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) managed in the endocrinology department.
Methods:
A single-center, retrospective cohort design was employed, enrolling 138 consecutive hospitalized patients who initiated finerenone therapy for the first time in our endocrinology department between June 2023 and December 2024. Baseline data and subsequent outpatient follow-up records were extracted to calculate the FIB-4 and assess changes in hepatic and renal function, serum potassium levels, and adverse events during treatment.
Results:
Of the enrolled cohort, 119 patients (85.6%) had complete baseline laboratory profiles, with a mean age of 63.1 years and 58% male. Baseline FIB-4 median 1.15. Among 52 patients (43%) who completed follow-up, the median follow-up duration was 6 months (range 1-16 months). The median follow-up FIB-4 declined to 1.10, representing an absolute reduction of 0.05. Patients with follow-up exceeding 12 months follow-up showed a further reduction to 0.96. Importantly, no cases of treatment discontinuation due to hyperkalemia were documented during follow-up.
Conclusion:
In real-world clinical practice, finerenone in T2DM patients with CKD trended to lower FIB-4 values, especially with longer use. However, no statistical significance and study limitations preclude definitive conclusions on its antifibrotic activity. These findings are hypothesis-generating and need confirmation in large, prospective, long-term studies with robust endpoints and proper controls.
Insights
Finerenone showed a trend toward reducing liver fibrosis marker FIB-4 in type 2 diabetes and kidney disease patients. Longer treatment duration correlated with greater FIB-4 reduction, with a good safety profile observed.
Area of Science:
- Endocrinology
- Nephrology
- Hepatology
Background:
- Type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) are associated with increased risk of liver fibrosis.
- Nonsteroidal selective mineralocorticoid receptor antagonists (nsMRAs) like finerenone are emerging as therapeutic options.
Purpose of the Study:
- To evaluate the impact of finerenone on the FIB-4 index, a marker of liver fibrosis.
- To assess the safety profile of finerenone in hospitalized T2DM patients with CKD.
Main Methods:
- Retrospective cohort study of 138 hospitalized T2DM patients initiating finerenone.
- Collected baseline and follow-up data to calculate FIB-4, monitor liver/renal function, potassium levels, and adverse events.
Main Results:
- Median FIB-4 decreased from 1.15 at baseline to 1.10 after a median follow-up of 6 months.
- Patients with over 12 months of follow-up showed a further FIB-4 reduction to 0.96.
- No treatment discontinuations due to hyperkalemia were reported.
Conclusions:
- Finerenone demonstrated a trend towards lowering FIB-4 in T2DM patients with CKD in real-world practice.
- Longer finerenone use may be associated with greater reductions in liver fibrosis markers.
- Findings are hypothesis-generating, requiring confirmation in larger prospective studies.
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