Additive improvement induced by bezafibrate in patients with primary biliary cirrhosis showing refractory response to ursodeoxycholic acid

Yasuto Takeuchi, Fusao Ikeda, Shin ichi Fujioka, Toshiyuki Takaki, Toshiya Osawa, Tetsuya Yasunaka, Yasuhiro Miyake, Akinobu Takaki, Yoshiaki Iwasaki, Haruhiko Kobashi, Kazuhide Yamamoto, Tatsuya Itoshima

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Background and Aim: Ursodeoxycholic acid (UDCA) has been widely used in the treatment of patients with primary biliary cirrhosis (PBC). However, some patients are refractory to UDCA. The aim of this study is to clarify the additive improvement induced by bezafibrate in patients refractory to UDCA. Methods: This study was a prospective analysis of 37 consecutive PBC patients. All patients were treated first for 6months with UDCA, and then with bezafibrate, if their alkaline phosphatase (ALP) levels did not decrease more than 40% or within the normal range after 6months' treatment with UDCA. Clinical parameters were monitored for the subsequent 24months. Result: Twenty-two patients (59%) achieved improvement of ALP levels after the treatment with UDCA. Those patients (Group A) had significantly lower levels of ALP at diagnosis than those with abnormal ALP levels after 6months' treatment with UDCA (Group B; P=0.020). They continued UDCA monotherapy, and maintained normal ALP levels at subsequent follow ups. However, immunoglobulin M (IgM) levels remained abnormal in eight patients, whose IgM levels at the time of diagnosis were significantly higher than those whose IgM were normalized after 6months' treatment with UDCA (P=0.026). Those in Group B were treated additionally with bezafibrate, and 12 patients (80%) achieved normal ALP and IgM levels within 12months of commencement of therapy. Conclusion: Higher ALP level at diagnosis is one of the predictors for UDCA failure. Combination treatment of bezafibrate in addition to UDCA may be an effective treatment for PBC patients refractory to UDCA.

Original languageEnglish
Pages (from-to)1395-1401
Number of pages7
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume26
Issue number9
DOIs
Publication statusPublished - 2011

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Bezafibrate
Ursodeoxycholic Acid
Biliary Liver Cirrhosis
Alkaline Phosphatase
Immunoglobulin M
Therapeutics

Keywords

  • Bezafibrate
  • Primary biliary cirrhosis
  • Ursodeoxycholic acid

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Additive improvement induced by bezafibrate in patients with primary biliary cirrhosis showing refractory response to ursodeoxycholic acid. / Takeuchi, Yasuto; Ikeda, Fusao; Fujioka, Shin ichi; Takaki, Toshiyuki; Osawa, Toshiya; Yasunaka, Tetsuya; Miyake, Yasuhiro; Takaki, Akinobu; Iwasaki, Yoshiaki; Kobashi, Haruhiko; Yamamoto, Kazuhide; Itoshima, Tatsuya.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 26, No. 9, 2011, p. 1395-1401.

Research output: Contribution to journalArticle

Takeuchi, Yasuto ; Ikeda, Fusao ; Fujioka, Shin ichi ; Takaki, Toshiyuki ; Osawa, Toshiya ; Yasunaka, Tetsuya ; Miyake, Yasuhiro ; Takaki, Akinobu ; Iwasaki, Yoshiaki ; Kobashi, Haruhiko ; Yamamoto, Kazuhide ; Itoshima, Tatsuya. / Additive improvement induced by bezafibrate in patients with primary biliary cirrhosis showing refractory response to ursodeoxycholic acid. In: Journal of Gastroenterology and Hepatology (Australia). 2011 ; Vol. 26, No. 9. pp. 1395-1401.
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abstract = "Background and Aim: Ursodeoxycholic acid (UDCA) has been widely used in the treatment of patients with primary biliary cirrhosis (PBC). However, some patients are refractory to UDCA. The aim of this study is to clarify the additive improvement induced by bezafibrate in patients refractory to UDCA. Methods: This study was a prospective analysis of 37 consecutive PBC patients. All patients were treated first for 6months with UDCA, and then with bezafibrate, if their alkaline phosphatase (ALP) levels did not decrease more than 40{\%} or within the normal range after 6months' treatment with UDCA. Clinical parameters were monitored for the subsequent 24months. Result: Twenty-two patients (59{\%}) achieved improvement of ALP levels after the treatment with UDCA. Those patients (Group A) had significantly lower levels of ALP at diagnosis than those with abnormal ALP levels after 6months' treatment with UDCA (Group B; P=0.020). They continued UDCA monotherapy, and maintained normal ALP levels at subsequent follow ups. However, immunoglobulin M (IgM) levels remained abnormal in eight patients, whose IgM levels at the time of diagnosis were significantly higher than those whose IgM were normalized after 6months' treatment with UDCA (P=0.026). Those in Group B were treated additionally with bezafibrate, and 12 patients (80{\%}) achieved normal ALP and IgM levels within 12months of commencement of therapy. Conclusion: Higher ALP level at diagnosis is one of the predictors for UDCA failure. Combination treatment of bezafibrate in addition to UDCA may be an effective treatment for PBC patients refractory to UDCA.",
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AU - Takeuchi, Yasuto

AU - Ikeda, Fusao

AU - Fujioka, Shin ichi

AU - Takaki, Toshiyuki

AU - Osawa, Toshiya

AU - Yasunaka, Tetsuya

AU - Miyake, Yasuhiro

AU - Takaki, Akinobu

AU - Iwasaki, Yoshiaki

AU - Kobashi, Haruhiko

AU - Yamamoto, Kazuhide

AU - Itoshima, Tatsuya

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