A Prospective, Two Arm, Randomized Single Centre, Comparative Study to Evaluate Efficacy and Safety of Obeticholic Acid and Saroglitazar in Patients of Non- alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH)

Background and Aim: NAFLD/NASH has been a burgeoning cause for cirrhosis worldwide, but pharmacotherapy for the same remains elusive. Only Saroglitazar so far has received acceptance from DCGI. This study explores the potential efficacy of Obeticholic acid in patients of NAFLD/NASH. Methods: This prospective, randomized, double blinded comparative study to evaluate efficacy and safety of Obeticholic acid 10 mg (n =50) and Saroglitazar 4mg (n =50) in patients of NAFLD/NASH in a real world setting. All patients were analysed for change in primary outcomes i.e Fibrosis (LSM) and steatosis (CAP) at baseline and at 24 weeks measured through Fibroscan and Secondary outcomes including, ALT, AST, and Lipid profile, and NITs (BARD score, Fib4 scores) were also noted. Results: Baseline Characterstics among the group were matched. Both Obeticholic acid and saroglitazar reduced LSM significantly from baseline. In Obeticholic acid group LSM reduced ( 11.84 to 8.31) by 20.9% p value <0.001 while in Saroglitazar limb it reduced by ( 14.75 to 9.61)by 23.20% p value <0.001 at 24 weeks, however there was no significant difference between 2 groups p value < 0.26. Simillarly, CAP in Obeticholic acid group reduced by ( 321db/m to 251db/m )21% with p value <0.001 while in Saroglitazar limb it reduced by ( 307db/m to 268db/m) by 10.70 % P VALUE ,0.001. CAP value reduced more significantly in Obeticholic acid group as compared to Saroglitazar limb p value of .0.01. Secondary endpoints ALT, AST, lipid profile FIB 4 and BARD score also improved significantly in both the groups post 24 weeks of treatment and with no difference between the groups. Conclusion: Obeticholic acid has a comparable effect with Saroglitazar in reducing Fibrosis (LSM), ALT, AST and serum Triglyceride, while it has an edge over the Saroglitazar in reducing Steatosis (CAP) Also there were no-adverse effects in terms of derranged lipd profile with Obeticholic acid as reported in previous study.