title: Bezafibrate treatment of primary biliary cirrhosis following incomplete response to ursodeoxycholic acid.
abstract: OBJECTIVE
  Ursodeoxycholic acid (UDCA) is the only current pharmacologic treatment for primary biliary cirrhosis (PBC). However, some patients show persistent liver biochemical abnormalities even after 6 to 12 months treatment. Bezafibrate retard is a commonly used medication for hyperlipidemia. In Japanese studies, it was found to lower liver enzyme levels, apparently through its action on multiple drug resistance gene 3, a transport element of the ATP-dependent bile secretion system, and on peroxisome proliferator-activated receptor-alpha. The aim of this study was to evaluate the effect of adding bezafibrate to the treatment regimen in patients with PBC and a partial response to UDCA.
  
  
  METHODS
  The study group included 8 White patients, 7 women and 1 man, aged 52 to 76 years with PBC who had been treated at our Liver Institute with UDCA (900 mg/d to 1500 mg/d) for 2 to 11 years (mean, 5.7 y) with only a partial response (19% to 56% reduction in alkaline phosphatase level). Bezafibrate (400 mg/d) was added to UDCA and the patients were followed for 4 to 12 months.
  
  
  RESULTS
  Alkaline phosphatase levels (normal range, 35 to 104 U/L) decreased in all patients, from 140 to 360 U/L (mean, 201.2) to 68 to 158 U/L (mean, 98.4), and normalized in 6 patients. In addition, levels of gamma-glutamyl transferase (normal range, 6 to 42 U/L) decreased from 70 to 192 U/L (mean, 130) to 41 to 122 U/L (mean, 71.8). These findings were maintained throughout follow-up.
  
  
  CONCLUSIONS
  Combination therapy with bezafibrate and UDCA improves the biochemical profile of patients with PBC who respond only partially to UDCA. A larger controlled study is needed to evaluate the clinical implications of these findings.
authors.affiliation: Department of Medicine D, Liver Institute, Rabin Medical Center Beilinson Hospital, Sackler School of Medicine Tel-Aviv University, Petah-Tikva, Israel. rawihazzan@hotmail.com
authors.forename: Rawi
authors.initials: R
authors.lastname: Hazzan
authors.forename: Ran
authors.initials: R
authors.lastname: Tur-Kaspa
mesh_terms: D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D001629:Bezafibrate / Q000008:administration & dosage / Q000627:therapeutic use*; D002756:Cholagogues and Choleretics / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D002756:Cholagogues and Choleretics; D000960:Hypolipidemic Agents; D014580:Ursodeoxycholic Acid; D005723:gamma-Glutamyltransferase; D000469:Alkaline Phosphatase; D001629:Bezafibrate