1034 Efficacy and Safety of Saroglitazar in Nonalcoholic Fatty Liver Disease Patients at 1 Year: An Investigator Initiated Study

Abstract

INTRODUCTION: Currently there is no drug or therapy approved for NAFLD. Although there are many drugs which have been explored for their usage in NAFLD/NASH. Saroglitazar is one of such novel dual peroxisome proliferator-activated receptors-α/γ agonist drug approved for diabetic dyslipidemia in India and is being investigated for treatment of NAFLD. In this current observational study we have tried to explore the efficacy of Saroglitazar in NAFLD patients with dyslipidemia. METHODS: This is a single centre, single arm, open label study of Saroglitazar conducted in northern India. Obese/overweight patients having Fatty Liver (on USG), elevated transaminases and dyslipidemia with or without type 2 diabetes were enrolled. All the patients were given Saroglitazar 4 mg once daily for at least 1 year. Patients with concomitant liver disease due to other etiologies (alcohol, viral etc.) were excluded. The laboratory parameters and LSM reports at baseline and 1 year were compared using t test. RESULTS: A total of 64 patients with mean age of 41.95 ± 8.56 years were enrolled in the study. The ratio of male to female was 84.38 (N:54): 15.62 (N:10). Out of 64 patients 17 Diabetic, 30 Non- diabetic and 17 were Prediabetic. The baseline and follow up of aspartate aminotransferase (AST), alanine aminotransferase (ALT), Total Cholesterol, triglycerides (TG) and liver stiffness measurement values were given in Table 1. There was a consistent and significant reduction in Total Cholesterol, TG, ALT, AST and LSM. There were no reported adverse events pertaining to Hypoglycemia. CONCLUSION: Saroglitazar was found to be safe and effective in management of NAFLD patients in this interim analysis of 12 months follow up. It is a potential option and need further exploration for management of dyslipidemia and NAFLD in non diabetic patients.