A pilot trial of high-dose ursodeoxycholic acid in nonalcoholic steatohepatitis

Leon A. Adams, Paul Angulo, Jan Petz, Jill Keach, Keith D. Lindor

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Purpose: Standard dose (13-15 mg/kg) ursodeoxycholic acid (UCDA) is ineffective in the treatment of nonalcoholic steatohepatitis (NASH), however, its immunomodulatory and hepatoprotective effects are dose related. Therefore, we examined the impact of high-dose (28-32 mg/kg) UCDA on aminotransaminase levels in a pilot study of patients with NASH. Methods: Twelve patients with biopsy-proven NASH and elevated aminotransaminases were prescribed high-dose UCDA for 6 months. Liver function tests were monitored during and after treatment with the study endpoint defined as normalization of aminotransaminase levels. Results: Normalization of aspartate aminotransaminase (AST) levels was observed in two (17%) patients, however, no patient normalized their alanine aminotransaminase (ALT) levels. A trend towards a minor reduction in median (range) ALT values from baseline to end of treatment was noted [124 (66-229) vs. 101 (53-188) IU/l, p = 0.07], whereas AST levels remained unchanged [85 (40-132) vs. 98 (28-147) IU/l, p = 0.83]. One patient discontinued treatment prematurely due to diarrhea. No significant change in fasting glucose, triglyceride or HDL cholesterol was observed with treatment. No significant change in ALT or AST levels was observed in the 6-month period after cessation of treatment. Conclusion: High-dose UCDA does not normalize aminotransaminase levels in patients with NASH. Other inexpensive well-tolerated agents for the treatment of NASH need to be investigated.

Original languageEnglish (US)
Pages (from-to)628-633
Number of pages6
JournalHepatology International
Issue number3
StatePublished - Sep 2010
Externally publishedYes


  • Aminotransaminase
  • Nonalcoholic steatohepatitis
  • Ursodeoxycholic acid

ASJC Scopus subject areas

  • Hepatology


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