Bezafibrate treatment: a new medical approach for PBC patients?

J Gastroenterol. 2003;38(6):573-8. doi: 10.1007/s00535-002-1102-7.


Background: A new medical approach to primary biliary cirrhosis (PBC) has been desired. We investigated the feasibility of using combination ursodeoxycholic acid (UDCA)-bezafibrate therapy in patients with PBC nonresponsive to UDCA monotherapy.

Methods: During a 6-month period, 22 PBC patients with elevated serum alkaline phosphatase (ALP) despite UDCA monotherapy received either UDCA at 600 mg/day (control group) or UDCA at 600 mg/day plus bezafibrate at 400 mg/day (bezafibrate group). Each patient underwent detailed clinical and biochemical evaluation.

Results: During treatment, changes in ALP level were greater in the bezafibrate group than in the control group (P< 0.01). During and at the end of treatment, serum ALP levels were significantly lower than those before treatment in patients receiving UDCA plus bezafibrate (P< 0.05). At the end of the 6 months, normalization of serum ALP was observed in 5 of 11 (45.4%) patients given bezafibrate and in 2 of 11 (18.1%) patients not given bezafibrate (P< 0.16). Bile acid proportions during the combination therapy did not change. Pruritus disappeared in 1 of 7 bezafibrate-group patients with this symptom.

Conclusions: UDCA at 600 mg/day plus bezafibrate at 400 mg/day may be considered as a new therapeutic option for patients with PBC.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Alkaline Phosphatase / blood
  • Bezafibrate / administration & dosage
  • Bezafibrate / therapeutic use*
  • Bile Acids and Salts / blood
  • Cholagogues and Choleretics / administration & dosage
  • Cholagogues and Choleretics / therapeutic use*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hypolipidemic Agents / administration & dosage
  • Hypolipidemic Agents / therapeutic use*
  • Liver Cirrhosis, Biliary / drug therapy*
  • Male
  • Middle Aged
  • Time Factors
  • Ursodeoxycholic Acid / administration & dosage
  • Ursodeoxycholic Acid / therapeutic use*


  • Bile Acids and Salts
  • Cholagogues and Choleretics
  • Hypolipidemic Agents
  • Ursodeoxycholic Acid
  • Alkaline Phosphatase
  • Bezafibrate