A Prospective Randomised Comparative Four-arm Intervention Study of Efficacy and Safety of Saroglitazar and Vitamin E in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH)-SVIN TRIAL

Abstract

Background and AimVitamin E is widely prescribed for Non-alcoholic steatohepatitis (NASH).Saroglitazar, a novel dual PPAR ɑ/γ agonist, is approved in India for Non-alcoholic fatty liver disease(NAFLD).No head-to-head comparative study for vitamin E and saroglitazar is available. We studied the efficacy and safety of saroglitazar and vitamin E in NAFLD/NASH. Materials and MethodsWe prospectively randomised 175 NAFLD patients into four arms as; Saroglitazar 4mg daily alone (n=44),vitamin E 800IU daily alone (n=41), vitamin E and saroglitazar combination(n=47) and control arm (n=43). All the baseline variables including Liver stiffness measurement (LSM) and Controlled attenuation parameter (CAP) were recorded.Reassessment was done after 24 weeks of treatment. ResultsThe mean age and BMI was 45±11 years and 26±3.6 kg/m2 respectively. Compared to control, the decrease in ALT levels with saroglitazar, vitamin E and combination therapy was significant (95% CI, 6.27-28.25,p=0.002, 95% CI, -3.39-18.88, p=0.047 and 95% CI 8.10-29.54,p=0.001 respectively).The reduction in CAP was significant with saroglitazar and combination therapy (95% CI, -31.94-11.99,p=0.015 and 95% CI, -10.48-30.51,p=0.026 respectively).Only combination therapy shows significant reduction in LSM (95% CI, 0.41-1.68,p=0.001).Among glycaemic parameters, both saroglitazar alone and combination therapy significantly improved HBA1C levels (P=0.001 and P=0.015) and only combination therapy significantly improved HOMA-IR (P=0.047).Saroglitazar alone showed significant reduction in TG and LDL levels (P=0.038 and P=0.018), and combination therapy showed significant increase in HDL levels (P=0.024). ConclusionsCombination of Saroglitazar and vitamin E showed statistically significant reduction of LSM and CAP along with biochemical, glycaemic and lipid parameters. Clinical Trial Registry India no(CTRI/2022/01/039538).