Evaluating Real-World Evidence of Effectiveness and Safety of Ursodeoxycholic Acid, Saroglitazar, and Vitamin E Monotherapies in Indian Patients with Non-Alcoholic Fatty Disease and Cholestasis: The ELITE Study

Background: Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease, and its prevalence is increasing in India. There have been limited real-world evidence studies in India on ursodeoxycholic acid (UDCA), saroglitazar, and vitamin E treatments for NAFLD with cholestasis. Objective: This study aimed to analyze the effectiveness and safety of UDCA, saroglitazar, and vitamin E in treating NAFLD with cholestasis. Methods: This retrospective, multicentric, real-world observational study involved adult Indian NAFLD patients with cholestasis treated with UDCA, saroglitazar, or vitamin E. Patient demographics, clinical parameters, and laboratory investigation results were retrieved from electronic medical records (EMRs) of the study sites. The effectiveness of each treatment was assessed based on the reduction in alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), and gamma-glutamyl transferase (GGT) levels at 2 and 4 weeks from baseline. The adverse events associated with these monotherapies were identified to assess their safety. Results: In this study, 50 patients from three different sites in India were identified through EMR data based on the inclusion/exclusion criteria (mean age, 39.22 years; 56% male). Enzyme reductions in AST, ALT, ALP, and GGT levels from baseline to 2 and 4 weeks were found in all treatment groups, However, UDCA treatment showed the highest reductions in ALT (38.36% vs. 24.83% vs. 12.42%), AST (50.05% vs. 29.69% vs. 25.63%), ALP (40.34% vs. 25.41% vs. 16.45%), and GGT (51.15% vs. 28.45% vs. 22.49%) levels compared to treatment with vitamin E and saroglitazar, respectively. One mild adverse event, acid reflux, was reported in the saroglitazar group. Conclusion: The study found that UDCA was significantly more effective than saroglitazar and vitamin E in reducing enzyme levels after 4 weeks. Further studies are needed to confirm these results, which could help to update clinical guidelines for treating NAFLD with cholestasis in India. Keywords: Non-alcoholic Fatty Liver Disease (NAFLD); Ursodeoxycholic Acid; Vitamin E; Saroglitazar; Pharmacotherapy; Alanine Transaminase; Aspartate Aminotransferase; Alkaline Phosphatase; Gamma-glutamyl Transferase