The role of saroglitazar in the treatment of metabolic dysfunction-associated steatohepatitis in non-diabetic patients: A prospective observational study

Metabolic dysfunction-associated steatohepatitis (MASH) is a metabolic disease characterized by hepatic fat accumulation and significant inflammation. Patients with hepatic steatosis who also have at least one of the five cardiometabolic risk markers are considered to have metabolic dysfunction-associated steatotic liver disease. MASH is diagnosed when a microscopic examination of liver tissue reveals fat accumulation in hepatocytes along with inflammation and destruction of liver cells. This study aims to assess the role of saroglitazar, a dual proliferator peroxisome-activated receptor agonist, in the medical therapy of MASH in non-diabetic patients. A prospective observational study was carried out in a tertiary care facility in north India. A total of 51 non-diabetic MASH patients (males and females, 18 – 75 years of age, body mass index ≥18.5 kg/m2) were included in this study. Diagnosis of MASH was based on liver FibroScan (controlled attenuation parameter [CAP] score >238, liver stiffness measurement [LSM] value >7kPa) along with raised liver enzymes (serum glutamic-oxaloacetic transaminase [SGOT], serum glutamic-pyruvic transaminase [SGPT] > upper value of normal limits). All these 51 patients received 4 mg once-daily dose of saroglitazar for the treatment of MASH for 24 weeks. In this study, a standard treatment protocol was used. The percentage changes in aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, triglyceride, low-density lipoprotein (LDL), and LSM with CAP were evaluated using an analysis of variance test and multiple regression analysis. About 72.5% of these patients were male and 27.5% were female (male: female ratio of 2.6). The mean age of patients was 51 ± 13.13 years. Pre- and post-treatment values of different parameters were compared. Pre-treatment mean values of ALT and AST were 93.83 ± 6.16 U/L and 76.13 ± 4.1 U/L, respectively, while their post-treatment mean values were 32.97 ± 2.15 U/L and 34.57 ± 1.65 U/L, respectively (P-value for AST and ALT <0.001). In conclusion, saroglitazar is effective in the medical management of MASH by reducing liver stiffness and suppressing elevated liver enzymes (SGOT/SGPT) as well as serum LDL levels over 6 months.