Loading...
Pharmacologic therapy remains unavailable for the treatment of nonalcoholic steatohepatitis (NASH). Obeticholic acid, a bile-acid derivative and potent activator of the farnesoid X nuclear receptor, has reduced liver fat and fibrosis in animal studies. Could it successfully treat NASH in humans?
To find out, investigators randomized 283 patients with noncirrhotic, biopsy-proven NASH to receive obeticholic acid (25 mg) or placebo daily for 72 weeks in an industry-funded, multicenter, double-blind study. The primary outcome was improvement in liver histology, defined as a decrease of ≥2 points in the fatty liver disease activity score without worsening fibrosis.
In an intention-to-treat analysis of 219 patients with posttreatment biopsy, 45% of…