Efficacy of fenofibrate in Chinese patients with primary biliary cirrhosis partially responding to ursodeoxycholic acid therapy

J Dig Dis. 2012 Apr;13(4):219-24. doi: 10.1111/j.1751-2980.2012.00574.x.

Abstract

Objective: To investigate the efficacy of fenofibrate combination therapy in Chinese patients with primary biliary cirrhosis (PBC) who had a partial response to standard dose of ursodeoxycholic acid (UDCA) for at least one year.

Methods: PBC patients were treated with UDCA (13-15 mg/kg/day) for more than one year. The biochemical response to UDCA treatment was evaluated after treatment. Fenofibrate (200 mg/day) was added to 22 patients with partial response to UDCA.

Results: In patients with partial response to UDCA, serum alkaline phosphatase (ALP) and γ-glutamyl transpeptidase levels significantly decreased after 3-month combination therapy of UDCA and fenofibrate, 68% of these patients even reached normal ALP level. Serum triglyceride (TG) and cholesterol levels were improved, and alanine transaminase (ALT) and aspartate transaminase (AST) were also decreased during the combination therapy. However, fenofibrate had no significant effect on serum bilirubin levels. The improvement of liver biochemical tests was maintained in some patients with long-term therapy (at least 6 months). No obvious adverse effects were observed in patients taking fenofibrate.

Conclusions: Fenofibrate is effective for improving liver biochemical tests in patients who have partial response to UDCA monotherapy. It is worth exploring the efficacy of fenofibrate on histological changes in PBC patients.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Asian People
  • Biomarkers / metabolism
  • Cholagogues and Choleretics / administration & dosage*
  • Drug Therapy, Combination
  • Female
  • Fenofibrate / administration & dosage*
  • Humans
  • Hypolipidemic Agents / administration & dosage*
  • Liver Cirrhosis, Biliary / drug therapy*
  • Liver Cirrhosis, Biliary / metabolism
  • Male
  • Middle Aged
  • Treatment Outcome
  • Ursodeoxycholic Acid / administration & dosage*

Substances

  • Biomarkers
  • Cholagogues and Choleretics
  • Hypolipidemic Agents
  • Ursodeoxycholic Acid
  • Fenofibrate