Improvement of hepatic steatosis by Saroglitazar and Vitamin E in patients of Non Alcoholic Fatty Liver Disease (NAFLD) with metabolic risk factors: A prospective, comparative, observational study

Abstract

Background and Aim: Reduction of hepatic steatosis using magnetic resonance imaging - proton density fat fraction (MRI-PDFF) has been used as a surrogate marker of treatment efficacy in Non Alcoholic Fatty Liver Disease (NAFLD) trials. We aimed, to assess the comparative efficacy of saroglitazar and vitamin E in improving hepatic steatosis, biochemical parameters and fibrosis scores in NAFLD patients with metabolic risk factor(s). Methods: 60 consecutive NAFLD patients with one or more metabolic risk factors were enrolled to receive either saroglitazar (4 mg, n=30) or Vitamin E (800 mg, n=30) for a period of 12 weeks. Liver fat content (by MRI-PDFF), biochemical parameters and FIB-4 score were assessed at baseline and after 12 weeks. Results: Both saroglitazar and vitamin E reduced liver fat content significantly from baseline [51.17 (±15.85) % in saroglitazar group (p < 0.0001), 47.27 (±17.63) % in vitamin E group (p < 0.0001)], however, there was no significant difference between the two groups (p = 0.39). Although, not reaching statistical significance, diabetic NAFLD patients receiving saroglitazar, had higher reduction of liver fat content compared to vitamin E [51.55 (±15.87) % vs 41.13 (±15.12) % (p = 0.08)]. Both the drugs caused significant reduction in ALT from baseline [42.67 (±18.64) % in saroglitazar group (p <0.0001) and 41.03 (±19.34) % in vitamin E group (p <0.0001)], however, there was no significant differences between the groups (p = 0.96). Reduction in FIB-4 scores were also similar between the two groups (p = 0.11). Conclusions: In patients with NAFLD with one or more metabolic risk factors, saroglitazar and vitamin E cause similar reductions in liver fat content, ALT and FIB-4 scores. In patients with diabetic NAFLD, saroglitazar showed a trend towards higher liver fat content reduction than vitamin E.