奥贝胆酸效果怎么样？

Fatty liver has always been a worldwide liver disease problem. No drug has been proven effective in decades. The new drug is approved for a rare disease called "primary biliary cirrhosis." In view of the amazing efficacy of obeticholic acid on patients with fatty liver in clinical trials, it will inevitably become our best weapon for preventing and treating fatty liver.

It has been proven effective in the treatment of non-alcoholic steatohepatitis (NASH), and the US FDA has granted it Breakthrough Therapy Designation. Clinical trials have shown that obeticholic acid has significant efficacy in treating patients with liver fibrosis caused by non-alcoholic steatohepatitis.

Results from the REGENERATE trial, a phase 3 trial, studying its investigational new drug obeticholic acid (OCA) versus placebo in the treatment of patients with liver fibrosis caused by nonalcoholic steatohepatitis (NASH). In terms of primary efficacy, a planned 18-month interim analysis showed that OCA 25 mg once daily met the primary endpoint of improvement in fibrosis (≥Grade 1) with statistical significance and no worsening of NASH (p = 0.0002 compared with placebo).

The trial showed that in the primary efficacy analysis, a greater proportion of patients in the obeticholic acid group achieved the primary endpoint of NASH resolution without worsening of liver fibrosis compared with placebo, but this did not reach statistical significance. The REGENERATE data tell us that obeticholic acid is expected to be the first approved drug for patients with liver fibrosis caused by NASH. Currently, in the field of research on fibrosis caused by NASH, obeticholic acid is still the only drug under development that has received FDA breakthrough therapy designation.