As
reported in the June 25, 2007 advance online edition of Gut, researchers
from the University of Tokyo assessed the effect of oral ursodeoxycholic acid
(UDCA) on serum biomarkers in non-responders to prior interferon-based therapy.
Chronic hepatitis C patients with elevated alanine aminotransferase (ALT) levels
were randomly assigned to receive UDCA at doses of 150 mg/day (n = 199), 600 mg/day
(n = 200), or 900 mg/day (n = 197) for 24 weeks. Changes in ALT, aspartate aminotransferase
(AST), and gamma-glutamyl transpeptidase (GGT) were measured.
Results
• ALT, AST, and GGT levels
decreased at week 4, then remained constant for the remainder of the drug administration
period.
• The median
changes in the UDCA 150, 600, and 900 mg/day dose groups, respectively, were:
-
ALT: -15.3%, -29.2%, and -36.2%; - AST: -13.6%, -25.0%, and -29.8%%; -
GGT: -22.4%, -41.0%, and -50.0%.
•
All 3 biomarkers decreased significantly less in the UDCA 150 mg/day arm compared
with the 2 higher dose groups.
•
While changes in ALT and AST did not differ between the 600 and 900 mg/day dose
groups, GGT was significantly lower in the 900 mg/day group.
•
In a subgroup analysis, ALT decreased significantly in the 900 mg/day group when
baseline GGT exceeded 80 IU/L.
•
Serum HCV RNA levels did not change in any group.
•
Adverse side effects were reported by 19.1% of the patients, with no differences
between the 3 dose groups.
Conclusion
In
conclusion, the authors wrote, "A 600 mg/day UDCA dose was optimal to decrease
ALT and AST levels in chronic hepatitis C patients. The 900 mg/day dose decreased
GGT levels further, and may be preferable in patients with prevailing biliary
injuries."
07/06/07
Reference M
Omata, H Yoshida, J Toyota, and others. A large-scale, multicentre, double-blind
trial of ursodeoxycholic acid in patients with chronic hepatitis C. Gut.
June 25, 2007 [Epub ahead of print].
