奥贝胆酸片功效和作用

Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestasis disease that mostly occurs in middle-aged and elderly women. The main clinical features are positive serum anti-mitochondrial antibodies and specific damage to the intrahepatic bile ducts. Currently, patients with incomplete clinical response to ursodeoxycholic acid (UDCA) are often treated with obeticholic acid or fibrates. In 2016, the U.S. Food and Drug Administration approved obeticholic acid as a second-line drug for PBC for the adjuvant treatment of patients with incomplete response to ursodeoxycholic acid. So, what are the effects and functions of obeticholic acid tablets?

Obeticholic acid tablets effects

Obeticholic acid is a farnesoid-X receptor agonist, which affects the synthesis, absorption, transport and secretion of bile acids by activating farnesoid-X receptors to achieve the purpose of treating PBC. Obeticholic acid is a highly efficient and selective FXR activator. It is currently mainly used for adult patients with primary biliary cirrhosis (PBC) who are ineffective or intolerant to UDCA alone. Its mechanism may be related to the activation of FXR. Studies have shown that obeticholic acid can significantly improve the maternal bile acid metabolism disorder induced by bacterial lipopolysaccharide (LPS) in late pregnancy and significantly improve the symptoms of ICP induced by 17α-ethinyl estradiol (E2) by acting on the FXR signaling pathway.

Obeticholic acid tablets efficacy

The REGENERATE study is the first successful Phase III study to obtain positive data in the field of new drug development for NASH. It is also the largest Phase III study conducted in patients with fibrosis caused by NASH, with more than 2,000 patients enrolled. This study was conducted in patients with stage 2/3 liver fibrosis due to NASH and evaluated the efficacy and safety of 2 doses of obeticholic acid compared with placebo. The primary efficacy analysis of the pilot study showed that obeticholic acid significantly improved fibrosis compared with placebo, meeting the primary endpoint of improvement in fibrosis without worsening of NASH. Obeticholic acid demonstrated robust efficacy across a range of histological and biochemical parameters.

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