A bstract Background: Empagliflozin, a sodium–glucose cotransporter-2 (SGLT-2) inhibitor, has shown its potential in mitigating metabolic dysfunction-associated steatotic liver disease (MASLD). This clinical trial aims to evaluate the efficacy of adding empagliflozin 10 mg/day to standard treatment for type 2 diabetes mellitus (T2DM), focusing on its impact on MASLD compared to conventional therapy alone. Objective: To assess the efficacy of empagliflozin in MASLD progression in patients with T2DM using noninvasive liver fibrosis markers. Materials and Methods: In this randomized controlled trial, a total of 76 patients with the diagnosis of T2DM with MASLD were enrolled, of whom 60 patients completed the study. Patients were equally divided into two groups taking standard treatment of T2DM with empagliflozin 10 mg/day in Group I (empagliflozin group) and standard treatment of T2DM without including empagliflozin or other SGLT-2 inhibitors, GLP-1 receptor agonists, or thiazolidinediones in Group II (control group). Statistical analysis was conducted to evaluate the association of noninvasive liver fibrosis markers, Fibrosis-4 (FIB-4) index, nonalcoholic fatty liver disease Fibrosis score (NFS), and using transient elastography, both controlled attenuated parameter (CAP) and liver stiffness kilopascal (kPa) were measured at baseline and after 24 weeks in both groups, and comparisons were made between them. Results: After 24 weeks, there was a significant decrease in FIB-4 ( P < 0.05) (from 0.86 ± 0.39 to 0.63 ± 0.25), CAP (from 244.37 ± 33 to 241.63 ± 34.03), kPa value (from 6.83 ± 1.53 to 6.68 ± 1.5), aspartate aminotransferase (AST), alanine transaminase (ALT), fasting blood sugar, hemoglobin A1c, and body mass index (BMI) among the patients in Group I compared to baseline. Between the groups, AST, FIB-4, CAP, and kPa reductions were significant. Pearson’s correlation showed positive correlations of CAP and kPa with BMI and of AST with FIB-4 index in both groups. Multivariate analysis after 24 weeks showed significant and positive associations of BMI with CAP, kPa, and NFS, and of AST and ALT with FIB-4. No significant adverse events were seen in either group during the study period. Conclusion: The study revealed that empagliflozin produced meaningful improvements in liver fibrosis based on non-invasive markers, glycemic control, liver enzyme profiles and body weight in patients with coexisting MASLD and type 2 diabetes, reinforcing its utility in this population.
Imran et al. (Mon,) studied this question.