A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis -

A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis
Information type: Randomised controlled trials
Source: New England Journal of Medicine
Specialities: Liver disorders
Summary
In this RCT (n=216) the primary end point (reduction of alkaline phosphatase level to <1.67 times the upper limit of the normal) occurred in more patients in the 5–10-mg group (46%) and the 10-mg group (47%) than in the placebo group (10%; P<0.001 for both comparisons).
UKMi comment
Obeticholic acid is a farnesoid X receptor agonist that has received accelerated FDA approval for the treatment of adults with primary biliary cholangitis who have an inadequate response to ursodiol or who are unable to take ursodiol because of side effects.
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