Effect of obeticholic acid in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) patients: a systematic review and meta-analysis

Abstract

Abstract Objectives Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are the major public health issues. Though the prevalence of the disease is high, there is no approved pharmacological treatment. Obeticholic acid (OCA) has not been well described in terms of its efficacy and safety in NAFLD/NASH patients. Hence, we investigated the efficacy and safety of OCA in NAFLD/NASH patients. Key findings PubMed, Cochrane CENTRAL and Google Scholar were searched from 2001 to date for identifying randomized controlled trials (RCTs) which examined the OCA effect on liver enzymes, lipoproteins and liver histology in NASH/NAFLD patients. Four relevant RCTs were identified and included for quantitative analysis. OCA exhibited significant reduction in ALT, AST and GGT levels, whereas in case of liver histology, significant improvement in steatosis, hepatocellular ballooning, lobular inflammation and fibrosis was observed in OCA treatment group [RR: 1.25, 95% CI: (1.03 to 1.52); P = 0.02; I2 = 53%], [RR: 1.39, 95% CI: (1.17 to 1.64); P = 0.0001; I2 = 0%], [RR: 1.23, 95% CI: (1.07 to 1.40); P = 0.002; I2 = 29%] and [RR: 1.85, 95% CI: (1.44 to 2.38); P < 0.00001; I2 = 0%], respectively. Summary Our results indicate that OCA might be used as a potential therapeutic drug candidate in NAFLD/NASH management.