Abstract
BACKGROUND: Diabetes and other metabolic abnormalities including high triglycerides (TGs) are commonly seen comorbid conditions in patients having nonalcoholic fatty liver disease (NAFLD). There is no approved pharmacotherapy for NAFLD, and life-style therapy plays a major role. Saroglitazar, the world's first approved dual PPAR α/γ agonist, is approved in India for the treatment of diabetic dyslipidemia. The objective of this case series analysis was to evaluate the safety and effectiveness of saroglitazar 4 mg once daily in reducing liver stiffness in patients having diabetic dyslipidemia associated NAFLD. METHOD: In this retrospective case series analysis, we identified 10 patients with diabetic dyslipidemia (type 2 diabetes and triglycerides >200 mg/dL at baseline) and NAFLD who were treated with saroglitazar 4 mg once daily and the follow-up data were available for 9 months after saroglitazar treatment. At baseline, all patients were on stable antidiabetic and statin therapy. Liver stiffness was measured by using 2D shear wave elastography at baseline and at 9-month follow-up. RESULTS: At 9-month follow-up after saroglitazar treatment, significant improvement was observed in shear wave velocity (SWV) and serum transaminases levels. Serum TG level was significantly reduced after 9-month treatment with saroglitazar. No major adverse event was reported. CONCLUSION: In this case series of 10 patients with diabetic dyslipidemia and NAFLD, saroglitazar improved liver stiffness along with reduction observed in liver enzymes and TG values. Long-term randomized controlled clinical trial is required to further establish the safety and efficacy of saroglitazar in treatment of NAFLD.