Safety and efficacy of dual PPARa/. agonist, Saroglitazar, in management of NAFLD with diabetes and/or dyslipidemia in liver transplant recipients

Background and Aim: The incidence of metabolic syndrome (MS) after Liver Transplantation (LT) is increasing with improved long-term care of LT recipients. Life-style modifications and pharmacotherapy continue to be the mainstay of management of MS. Saroglitazar, a dual PPAR-Alpha agonist, is effective in management of the Nonalcoholic Fatty Liver Disease (NAFLD) with dyslipidemia and is approved for the treatment of Nonalcoholic steatohepatitis (NASH) in India. Methods: This is a retrospective analysis of LT recipients who received Saroglitazar for the management of NAFLD with diabetes and/or dyslipidemia. Diagnosis of post-transplant NAFLD was based on imaging (Ultrasonography± Fibroscan) and/or liver biopsy. Patients were advised lifestyle modification and pharmacotherapy with Vitamin E. Twenty-eight patients who received Saroglitazar for at least 3 months were included in the study. Results: The mean age of patients who received Saroglitazar was 51.8 ± 9.7 years (27 males and 1 female). NAFLD was de novo in 17(60.7%) patients and recurrent in 11(39.3%) patients. At baseline, 20(71.4%) patients had Diabetes mellitus with metabolic syndrome, and 8(28.6%) had dyslipidemia. Nine (32.1%) patients had histopathological evidence of NAFLD, 6 (21.4%) of them had NASH. Saroglitazar (4mg/day) was initiated at a median period of 58(IQR 36.7-77.7) months after LT. Biochemical and metabolic parameters before and after Saroglitazar initiation are shown in Table 1. Over a median of 7.5(IQR 4.7-10.2) months, reductions in ALT, triglyceride, and Controlled Attenuation Parameter (CAP, measurement of steatosis on Fibroscan) were 11.8%, 24.6%, and 14.3% respectively. Saroglitazar was well tolerated without any significant adverse events. Conclusions: Saroglitazar is safe and effective in reducing transaminases and hypertriglyceridemia in post-transplant NAFLD with diabetes and/or dyslipidemia