Efficacy of Dapagliflozin vs. Saroglitazar on Hepatic Steatosis and Fibrosis in Patients of Type 2 Diabetes Mellitus and Metabolic-Associated Steatotic Liver Disease (MASLD).

INTRODUCTION: There is a rising prevalence of metabolic-associated steatotic liver disease (MASLD), particularly in patients with type 2 diabetes mellitus, which needs early detection and treatment to prevent the grave outcomes. Dapagliflozin and Saroglitazar are known to improve metabolic and liver health in patients with type 2 diabetes mellitus. METHODS: Our study was a randomised, controlled, open-label, parallel trial of 101 patients with T2DM and MASLD. Patients were randomly assigned to receive Dapagliflozin 10 mg or Saroglitazar 4 mg on top of standard diabetes care. The primary endpoints were changes in hepatic steatosis and fibrosis (FIB) as estimated by controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) using FibroScan, respectively. The secondary endpoints were changes in anthropometric parameters, glycemic parameters, lipid profiles, transaminases, and FIB scores, which were monitored at baseline, 3 months, and 6 months. RESULTS: At the end of 6 months of study, both cohorts resulted in significant clinical benefits. Comparison between the two cohorts revealed no significant statistical difference between the two groups regarding their impact on the primary endpoints (CAP and LSM). Minimal but statistically significant intergroup differences were noted only for BMI (P = 0.033) and LDL cholesterol (P = 0.020) in the Dapagliflozin cohort and alanine transaminase levels (P = 0.037) in the Saroglitazar cohort. CONCLUSION: Both Dapagliflozin and Saroglitazar are potent therapeutic options in patients with type 2 diabetes mellitus who also have MASLD.