Ursodeoxycholic and tauro-ursodeoxycholic acids for the treatment of primary biliary cirrhosis: a pilot crossover study.
BACKGROUND
Results from animal studies and preliminary data from pilot studies in patients with primary biliary cirrhosis suggest that tauro-ursodeoxycholic acid has metabolic properties that may favour its long-term use as an alternative to ursodeoxycholic acid for patients with chronic cholestatic liver diseases. No direct comparison of tauro-ursodeoxycholic and ursodeoxycholic acids have yet been carried out in primary biliary cirrhosis.


METHODS
The effects of ursodeoxycholic and tauro-ursodeoxycholic acids were compared in 23 patients with primary biliary cirrhosis according to a crossover design. Both drugs were administered at the daily dose of 500 mg. in a randomly assigned sequence for two 6-month periods separated by a 3-month wash-out period.


RESULTS
Serum liver enzymes related to cholestasis and cytolysis consistently improved, as compared to baseline values, during the administration of both ursodeoxycholic and tauro-ursodeoxycholic acids, but no significant difference between these two bile acids was found. Both treatments were well tolerated and no patient complained of side effects.


CONCLUSIONS
In the short-term, tauro-ursodeoxycholic acid appears to be safe and at least as effective as ursodeoxycholic acid for the treatment of primary biliary cirrhosis.
Larghi
A
A
Department of Internal Medicine, School of Medicine Ospedale San Paolo, University of Milan, Italy.
Crosignani
A
A
Battezzati
P M
PM
De Valle
G
G
Allocca
M
M
Invernizzi
P
P
Zuin
M
M
Podda
M
M
D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D018592:Cross-Over Studies; D006801:Humans; D008055:Lipids / Q000097:blood; D008099:Liver / Q000201:enzymology; D008105:Liver Cirrhosis, Biliary / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D010865:Pilot Projects; D013655:Taurochenodeoxycholic Acid / Q000627:therapeutic use*; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
D002756:Cholagogues and Choleretics; D008055:Lipids; D013655:Taurochenodeoxycholic Acid; C031655:ursodoxicoltaurine; D014580:Ursodeoxycholic Acid