Obeticholic acid (OCA) improved liver health in patients with nonalcoholic steatohepatitis (NASH) by decreasing inflammation and fat in the liver and by decreasing body weight, results of a clinical trial show. The study, supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), were published in The Lancet.
Obeticholic acid is a bile acid derivative (6-ethylchenoeoxycholic acid) that activates the farnesoid X nuclear receptor to reduce liver fat and fibrosis. The Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment Trial (FLINT) was a multi-center, double-blinded study that evaluated 283 patients that were diagnosed with definite or borderline NASH between March 16, 2011–December 3, 2012. Patients were randomized to either OCA 25mg daily or placebo for 72 weeks with an additional 24 weeks of follow-up.
An interim analysis, however, found that OCA showed improved efficacy on NASH-related liver health (P=0.0024) and supported a decision to not perform end-of-treatment biopsies in 64 of the patients. Forty-five percent of the patients in the COA group who were meant to have biopsies showed improved liver histology vs. 21% of the patients in the placebo group (RR 1.9, 95% CI 1.3–2.8; P=0.0002).
Results also showed increases in total LDL cholesterol and decreases in HDL cholesterol in the OCA treatment group. It was then decided to discontinue treatment but continue the study. No continued cholesterol increases were seen after discontinuing OCA. Further, improvements in liver enzymes with OCA were not sustained after discontinuing treatment.
Scientists noted that further research is needed to better understand the long-term effects of OCA on cholesterol and artery hardening.
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