Effect of Addition of Saroglitazar to Lifestyle Modifications in Patients with Nonalcoholic Fatty Liver Disease: A Prospective Observational Study.

OBJECTIVE

Nonalcoholic fatty liver disease (NAFLD) is a prevalent metabolic disorder with significant health implications. This study aims to evaluate the effect of adding Saroglitazar to lifestyle modifications in improving NAFLD-related parameters compared to lifestyle modifications alone.

METHODOLOGY: A prospective observational study was conducted at the Outpatient Department of Gastroenterology, M. S. Ramaiah Hospitals, including patients diagnosed with NAFLD. Patients were divided into two groups: Group 1 received lifestyle modification counseling, and Group 2 received Saroglitazar 4 mg OD in addition to lifestyle modification counseling for 12 weeks. Liver function tests and ultrasonographic findings were assessed at baseline and after 12 weeks.

RESULTS

A statistically significant improvement ( P = 0.02) in alanine transaminase (ALT) levels was observed within the treatment Group 2, along with a trend of improvement in aspartate transaminase (AST) levels ( P = 0.07). However, no significant difference in AST and ALT levels was found between the groups. Ultrasonographic improvements were noted in few patients receiving Saroglitazar, and the drug was well tolerated, with minor adverse events such as nausea and fatigue.

CONCLUSIONS

The addition of Saroglitazar to lifestyle modifications showed a beneficial effect in improving NAFLD-related parameters over 12 weeks compared to lifestyle modifications alone.