Treatment of nonalcoholic steatohepatitis with colestimide
Article first published online: 7 APR 2009
© 2009 The Japan Society of Hepatology
Volume 39, Issue 7, pages 685–693, July 2009
How to Cite
Taniai, M., Hashimoto, E., Tobari, M., Yatsuji, S., Haruta, I., Tokushige, K. and Shiratori, K. (2009), Treatment of nonalcoholic steatohepatitis with colestimide. Hepatology Research, 39: 685–693. doi: 10.1111/j.1872-034X.2009.00507.x
- Issue published online: 22 JUN 2009
- Article first published online: 7 APR 2009
- Received 27 October 2008; revised 14 January 2009; accepted 14 January 2009.
- lipid-lowering agents;
- nonalcoholic steatohepatitis
Aim: To clarify the usefulness of colestimide in patients with nonalcoholic steatohepatitis (NASH) with hyperlipidemia.
Methods: In an open-label randomized controlled trial, 17 NASH patients with hyperlipidemia received colestimide (3 g/day) for 24 weeks. There were 21 control patients. All patients received lifestyle modification therapy. Efficacy was assessed based on metabolic profile, insulin resistance, transaminases, serum hepatic fibrosis markers, adipokine levels, visceral fat on computed tomography (CT), and the fatty liver grade on CT. NASH patients with moderate to severe steatosis by histology were also evaluated separately.
Results: Baseline clinical characteristics of the two groups were similar. Both groups experienced a significant decrease of BMI with no difference between them. However, visceral fat decreased significantly more in the colestimide group (P = 0.046). Aspartate aminotransferase (AST) showed a significantly greater decrease in the colestimide group compared with the control group (P = 0.042). In patients with moderate to severe histological steatosis, there were significant differences between the two groups regard to HbA1c, transaminases, and hyaluronic acid (P = 0.018 for HbA1c, P = 0.003 for AST, P = 0.042 for alanine aminotransferase, and P = 0.042 for hyaluronic acid). Steatosis significantly improved in patients in the colestimide group who had fatty liver on CT (P = 0.049). In the colestimide group, abdominal distension and/or constipation were seen, but mostly tolerable, no other clinical or laboratory adverse events associated with the use of this medicine were not observed.
Conclusions: Colestimide seems to increase the efficacy of lifestyle modification in NASH patients with hyperlipidemia. Its beneficial effects were more prominent in NASH patients with moderate to severe histological steatosis.