Safety and Efficacy of Saroglitazar in Nonalcoholic Fatty Liver Patients With Diabetic Dyslipidemia-A Prospective, Interventional, Pilot Study

N A Rajesh; L Drishya; Murali Mohan Raju Ambati; Athi L Narayanan; Maria Alex; Kiran Kumar R; Justin J Abraham; T M Vijayakumar

doi:10.1016/j.jceh.2021.03.012

Safety and Efficacy of Saroglitazar in Nonalcoholic Fatty Liver Patients With Diabetic Dyslipidemia-A Prospective, Interventional, Pilot Study

J Clin Exp Hepatol. 2022 Jan-Feb;12(1):61-67. doi: 10.1016/j.jceh.2021.03.012. Epub 2021 Apr 9.

Authors

N A Rajesh¹, L Drishya², Murali Mohan Raju Ambati², Athi L Narayanan², Maria Alex², Kiran Kumar R², Justin J Abraham², T M Vijayakumar²

Affiliations

¹ Department of Medical Gastroenterology, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603 203, India.
² Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603 203, India.

Abstract

Background: Saroglitazar-a unique dual peroxisome proliferator-activated receptor agonist was approved marketing authorization in India in 2013 for diabetic dyslipidemia. Postmarketing studies have additionally shown improvement in liver parameters in diabetic dyslipidemia patients with nonalcoholic fatty liver disease (NAFLD) who received saroglitazar.

Aim: The aim of this study was to evaluate the effect of saroglitazar on liver function test, liver fibrosis score by FibroScan, lipid profiles, HbA1c in NAFLD patients with diabetic dyslipidemia in southern India.

Methodology: A prospective, interventional, pilot study was performed to study the safety and efficacy of saroglitazar in NAFLD patients having type 2 diabetes mellitus. About 97 patients were screened, of which 85 patients were involved in the study based on the inclusion criteria. The clinical parameters and liver stiffness were measured at the baseline and also after 12 weeks of treatment with administration of saroglitazar 4 mg once daily. The change in the parameters at the baseline and after the end of the treatment was measured and was subjected to statistical analysis using SPSS software.

Results: The recruited patients received saroglitazar and were followed up for a period of 12 weeks. The clinical parameters such as fasting blood sugar, postprandial blood sugar, HbA1c, total cholesterol, triglycerides, SGPT, and liver stiffness showed significant difference after 12 weeks of treatment when compared with the baseline values. No adverse drug reaction was reported in patients receiving saroglitazar during the study.

Conclusion: Saroglitazar was found to show significant improvement in liver parameters in NAFLD patients with a significant reduction in liver fibrosis and triglycerides level.

Keywords: AACE, American Associaton of Clinical Endocrinologists; ADR, Adverse Drug Reaction; ALT, Alanine Transaminase; BMI, Body Mass Index; CDSCO, Central Drugs Standard Control Organisation; CT Scan, Computed Tomography Scan; DBP, Diastolic Blood Pressure; DCGI, Drug Controller General of India; FBS, Fasting Blood Sugar; GLP1Ra, Glucagon Like Peptide 1 Receptor agonist; HCV, Hepatitis - C Virus; HDL, High Density Lipoprotein; HbA1C, Glycated Hemoglobin; IHEC, Institutional Human Ethics Committee; LDL-C, Low Density Lipoprotein Cholesterol; LSM, Liver Stiffness Measurement; MRI, Magnetic Resonance Imaging; NAFLD, Nonalcoholic Fatty Liver Disease; NASH, Non-Alcoholic Steatohepatitis; NPV, Negative Predictive Value; Na2EDTA, Sodium Ethylenedinitrilotetraacetic acid; PPAR, Peroxisome Proliferator Activated Receptor; PPBS, Post Prandial Blood Sugar; SBP, Systolic Blood Pressure; SDB, Serum Direct Bilirubin; SGLT2i, Sodium Glucose Co-Transporter-2 Inhibitor; SGOT, Serum Glutamate Oxaloacetic Transaminase; SGPT, Serum Glutamate Pyruvic Transaminase; SPSS, Statistical Package for the Social Sciences; STB, Serum Total Bilirubin; T2DM, Type 2 Diabetes Mellitus; TC, Total Cholesterol; TG, Triglycerides; TZD, Thiazolidinediones; USG, Ultra Sonography; VLDL, Very Low Density Lipoprotein; diabetic dyslipidemia; fibrosis level; non-alcoholic fatty liver disease; saroglitazar; ultrasound.