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INNOSC Theranostics

                                                  and Pharmacological Sciences




                                        ORIGINAL RESEARCH ARTICLE
                                        The role of saroglitazar in the treatment

                                        of metabolic dysfunction-associated
                                        steatohepatitis in non-diabetic patients: A

                                        prospective observational study



                                        Jata Shankar Kumar*, Priyanshu Bhardwaj, Akul Chadha , and
                                        Premashis Kar*

                                        Department of Medical Gastroenterology, Max Superspeciality Hospital, Vaishali, Ghaziabad, India



                                        Abstract

                                        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
            *Corresponding authors:     of liver cells. This study aims to assess the role of saroglitazar, a dual proliferator
            Jata Shankar Kumar          peroxisome-activated receptor agonist, in the medical therapy of MASH in non-
            (jatashankar.dr@gmail.com)
            Premashis Kar               diabetic patients. A prospective observational study was carried out in a tertiary
            (premashishkar@gmail.com)   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/m ) were included in this
                                                                                          2
            Citation: Kumar JS, Bhardwaj P,
            Chadha A, Kar P. The role of   study. Diagnosis of MASH was based on liver FibroScan (controlled attenuation
            saroglitazar in the treatment   parameter [CAP] score >238, liver stiffness measurement [LSM] value >7kPa) along
            of metabolic dysfunction-   with raised liver enzymes (serum glutamic-oxaloacetic transaminase [SGOT],
            associated steatohepatitis in
            non-diabetic patients: A prospective   serum glutamic-pyruvic transaminase [SGPT] > upper value of normal limits). All
            observational study. INNOSC   these 51 patients received 4 mg once-daily dose of saroglitazar for the treatment
            Theranostics and Pharmacological   of MASH for 24  weeks. In this study, a standard treatment protocol was used.
            Sciences. 2024;7(4):3560.
            doi: 10.36922/itps.3560     The percentage changes in aspartate transaminase (AST), alanine transaminase
                                        (ALT),  alkaline  phosphatase,  triglyceride,  low-density  lipoprotein  (LDL),  and
            Received: May 1, 2024
                                        LSM with CAP were evaluated using an analysis of variance test and multiple
            Accepted: August 13, 2024   regression analysis. About 72.5% of these patients were male and 27.5% were
            Published Online: October 4, 2024  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-
            Copyright: © 2024 This
            is an Open-Access article   treatment mean values of ALT and AST were 93.83 ± 6.16 U/L and 76.13 ± 4.1 U/L,
            distributed under the terms   respectively, while their post-treatment mean values were 32.97 ± 2.15 U/L and
            of the Creative Commons     34.57 ± 1.65 U/L, respectively (P-value for AST and ALT <0.001). In conclusion,
            AttributionNoncommercial License,
            permitting all non-commercial use,   saroglitazar is effective in the medical management of MASH by reducing liver
            distribution, and reproduction in any   stiffness and suppressing elevated liver enzymes (SGOT/SGPT) as well as serum
            medium, provided the original work   LDL levels over 6 months.
            is properly cited.
            Publisher’s Note: AccScience
            Publishing remains neutral with   Keywords: Hepatic steatosis; Hepatocytes; Metabolic dysfunction-associated
            regard to jurisdictional claims in   steatohepatitis; Proliferator peroxisome activated receptor; Saroglitazar
            published maps and institutional
            affiliations.


            Volume 7 Issue 4 (2024)                         1                                doi: 10.36922/itps.3560
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