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)

نویسندگان

چکیده

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

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ژورنال

عنوان ژورنال: Journal of clinical and experimental hepatology

سال: 2023

ISSN: ['0973-6883', '2213-3453']

DOI: https://doi.org/10.1016/j.jceh.2023.07.190