Prospective randomized crossover trial of combination therapy with bezafibrate and UDCA for primary biliary cirrhosis

Jun Itakura; Namiki Izumi; Yuki Nishimura; Kazunari Inoue; Ken Ueda; Hiroyuki Nakanishi; Kaoru Tsuchiya; Kosei Hamano; Yasuhiro Asahina; Masayuki Kurosaki; Masakatsu Uchihara; Shozo Miyake

doi:10.1016/j.hepres.2004.04.001

Prospective randomized crossover trial of combination therapy with bezafibrate and UDCA for primary biliary cirrhosis

Hepatol Res. 2004 Aug;29(4):216-222. doi: 10.1016/j.hepres.2004.04.001.

Authors

Jun Itakura¹, Namiki Izumi, Yuki Nishimura, Kazunari Inoue, Ken Ueda, Hiroyuki Nakanishi, Kaoru Tsuchiya, Kosei Hamano, Yasuhiro Asahina, Masayuki Kurosaki, Masakatsu Uchihara, Shozo Miyake

Affiliation

¹ Division of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino City, Tokyo 180-8610, Japan.

PMID: 15288014
DOI: 10.1016/j.hepres.2004.04.001

Abstract

The aim of this study was to evaluate the effects of the combination therapy with bezafibrate and ursodeoxycholic acid (UDCA) for primary biliary cirrhosis (PBC), compared to UDCA monotherapy. Sixteen patients with compensated PBC were divided randomly into two groups. Group A received treatment with bezafibrate and UDCA for 6 months, while group B received UDCA alone, treatment protocols were then exchanged for another 6 months. The laboratory data was followed every month. The mean levels of alkaline phosphatase (ALP) decreased significantly more in group A than in group B in the first half of the study. Then serum ALP levels were elevated in group A after exchanged the therapy, but fell down in group B. Serum levels of gamma-glutamyl transferase (GGT), immunoglobulin M and triglycerides values were significantly lower in group B than in group A, after changing therapies from monotherapy to combination therapy with bezafibrate and UDCA. The mean levels of ALP, GGT and triglycerides were significantly lower at the end of the combination therapy than those at the end of the monotherapy. The combination therapy with bezafibrate and UDCA significantly improves the laboratory data that specific for PBC in comparison with UDCA monotherapy.