Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis.

ABSTRACT:

Background & aims

Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of direct bilirubin in the phase 3, randomized, placebo-controlled Primary Biliary Cholangitis Obeticholic Acid International Study of Efficacy.

Methods

This analysis assessed patients on the basis of their baseline direct bilirubin level (divided by quartile). Biochemistry and safety outcomes were evaluated within each quartile over time.

Results

In the quartile with the highest baseline direct bilirubin (>5.47 µmol/L), there was a significant reduction in both direct and total bili

SUBMITTER: Pares A 

PROVIDER: S-EPMC7317821 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature