Bezafibrate treatment: a new medical approach for PBC patients?
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.
Kanda
Tatsuo
T
First Department of Medicine, Chiba University School of Medicine, Japan.
Yokosuka
Osamu
O
Imazeki
Fumio
F
Saisho
Hiromitsu
H
D000469:Alkaline Phosphatase / Q000097:blood; D001629:Bezafibrate / Q000008:administration & dosage / Q000627:therapeutic use*; D001647:Bile Acids and Salts / Q000097:blood; D002756:Cholagogues and Choleretics / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage / Q000627:therapeutic use*
D001647:Bile Acids and Salts; D002756:Cholagogues and Choleretics; D000960:Hypolipidemic Agents; D014580:Ursodeoxycholic Acid; D000469:Alkaline Phosphatase; D001629:Bezafibrate