Biochemical responses to bezafibrate improve long-term outcome in asymptomatic patients with primary biliary cirrhosis refractory to UDCA

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• 作者：Atsushi Tanaka ; Junko Hirohara ; Yasuni Nakanuma…
• 关键词：Bezafibrate ; Ursodeoxycholic acid ; Outcome ; Liver enzymes
• 刊名：Journal of Gastroenterology
• 出版年：2015
• 出版时间：June 2015
• 年：2015
• 卷：50
• 期：6
• 页码：675-682
• 全文大小：509 KB
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  25.Harada K, Hiro
• 作者单位：Atsushi Tanaka (1)
  Junko Hirohara (2)
  Yasuni Nakanuma (3)
  Hirohito Tsubouchi (4)
  Hajime Takikawa (1)
  
  1. Department of Medicine, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan
  2. The Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan
  3. Department of Human Pathology, Kanazawa University Graduate School of Medicine, Kanazawa, Japan
  4. Kagoshima City Hospital, Kagashima, Japan
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Gastroenterology
  Oncology
  Surgical Oncology
  Hepatology
  Internal Medicine
  Colorectal Surgery
  
• 出版者：Springer Japan
• ISSN：1435-5922

文摘

Background Bezafibrate is reported to have biochemical efficacy for patients with primary biliary cirrhosis (PBC) refractory to ursodeoxycholic acid (UDCA), yet the long-term effect is still unknown. In Japan, nationwide surveys of PBC have been performed since 1980. In the current study, we retrospectively examined whether response to bezafibrate treatment is associated with the long-term outcomes using this large-scale database. Methods Among 7,376 patients in the database, we enrolled patients who were treated with UDCA at 13-5?mg/kg per day and followed up for at least 2?years after diagnosis. Bezafibrate (400?mg/day) was administered in addition to UDCA when biochemical response to UDCA was not optimal. Response to bezafibrate treatment was determined by serum alanine transaminase (ALT) levels within 2-?years or at the earliest point thereafter from the commencement of bezafibrate treatment. Results We enrolled 1,121 PBC patients, and the observational period was 6.1?±?3.4?years. Among the PBC patients, 835 were asymptomatic, defined as no liver-related symptoms at the baseline. In asymptomatic PBC patients, multivariate analysis indicated that ALT response to bezafibrate treatment was significantly associated with the presence of liver-related symptoms at the end of observation [hazard ratio 1.46 (95?% confidence interval 1.01-.13), P?=?0.048]. The cumulative liver-related-symptoms-free rate of patients treated with bezafibrate and who had a normal ALT level was significantly higher than that of those treated with bezafibrate and who had an elevated ALT level (P?<?0.001), and was comparable to that of those who received UDCA monotherapy. Conclusion These results suggested that normalization of ALT levels with additional bezafibrate treatment significantly decreased the rate of occurrence of liver-related symptoms in asymptomatic PBC patients with suboptimal response to UDCA.