Prospective study of bezafibrate for the treatment of primary sclerosing cholangitis. (21st August 2015)

• Record Type: Journal Article
• Authors: Mizuno, Suguru; Hirano, Kenji; Isayama, Hiroyuki; Watanabe, Takeo; Yamamoto, Natsuyo; Nakai, Yousuke; Sasahira, Naoki; Tada, Minoru; Omata, Masao; Koike, Kazuhiko
• Is Part Of: Journal of hepato-biliary-pancreatic sciences. Volume 22:Number 10(2015)
• Page Start: 766
• Page End: 770
• Publication Date: 2015-08-21
• Subjects: Liver -- Diseases -- Periodicals; Biliary tract -- Diseases -- Periodicals; Pancreas -- Diseases -- Periodicals; 617.556
• DOI: 10.1002/jhbp.281
• Languages: English
• ISSNs: 1868-6974

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="jhbp281-sec-0001" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="jhbp281-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="jhbp281-sec-0003" sec-type="section"> <title>Results</title> <p>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 <italic>P</italic> < 0.05 by Wilcoxon's signed‐rank test), and both significantly increased after bezafibrate cessation (both <italic>P</italic> < 0.01).</p> </sec> <sec id="jhbp281-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>