title: Prospective study of bezafibrate for the treatment of primary sclerosing cholangitis.
abstract: BACKGROUND
  Primary sclerosing cholangitis (PSC) is a chronic cholestatic disease. Medical treatments must be devised to avoid or postpone liver transplantation in PSC patients. No clinical trial has prospectively explored the efficacy of bezafibrate in PSC patients.
  
  
  METHODS
  We conducted a prospective study of 12-week bezafibrate treatment, with pre- and post-treatment observation periods, in PSC patients. Bezafibrate was prescribed at 200 mg b.i.d. The primary endpoint was defined as improvements in liver function test (LFT) data after bezafibrate treatment. Changes in LFT data during the study period were assessed every 6 weeks.
  
  
  RESULTS
  Fifteen patients were enrolled as planned, and 11 completed the study protocol. Biliary enzyme levels improved in all patients after bezafibrate treatment for 12 weeks. Hepatic enzyme levels improved in only seven of the 11 patients, and the efficacy of bezafibrate in PSC patients was thus 64%. LFT data (alkaline phosphatase and alanine aminotransferase levels) were reduced after bezafibrate treatment (both P < 0.05 by Wilcoxon's signed-rank test), and both significantly increased after bezafibrate cessation (both P < 0.01).
  
  
  CONCLUSIONS
  Bezafibrate effectively improved LFT data in 64% of PSC patients. This is the first prospective clinical trial to evaluate the effect of bezafibrate in PSC patients.
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Suguru
authors.initials: S
authors.lastname: Mizuno
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirano
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Watanabe
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Natsuyo
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Sasahira
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Tada
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001629:Bezafibrate / Q000008:administration & dosage*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods; D015209:Cholangitis, Sclerosing / Q000175:diagnosis* / Q000188:drug therapy*; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006785:Hospitals, University; D006801:Humans; D007564:Japan; D008111:Liver Function Tests; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D001629:Bezafibrate
keywords: Bezafibrate; Drug therapy; Primary sclerosing cholangitis; Prospective study