One-year pilot study on tauroursodeoxycholic acid as an adjuvant treatment after liver transplantation.
BACKGROUND
The usefulness of ursodeoxycholic acid after liver transplantation is controversial. Tauroursodeoxycholic acid, the natural taurine-amidate, is a highly hydrophilic and cytoprotective bile salt currently under investigation.


OBJECTIVE
To investigate the clinical usefulness of tauroursodeoxycholic acid after liver transplantation.


METHODS
Thirty-three patients undergoing liver transplantation entered the study.


METHODS
Sixteen patients were randomized to receive tauroursodeoxycholic acid (250 b.i.d. for 12 months) and 17 served as controls. Tauroursodeoxycholic acid was given from day 5 after transplantation for one year.


RESULTS
Tauroursodeoxycholic acid treatment was safe and well tolerated. No drop outs occurred. Among the 29 patients undergoing long-term follow-up, five deaths occurred (3 of whom in the tauroursodeoxycholic acid group), none of which was related to treatment. The one-year actuarial survival was 78.6% in patients treated with tauroursodeoxycholic acid and 86.7% in controls (n.s.). No differences were observed with respect to early or late graft function and survival, nor to acute cellular rejection. Tauroursodeoxycholic acid therapy was associated with lower serum cholesterol levels (p < 0.02) during the early postoperative months; with milder cholestasis; with a drop in biliary cholates but no changes in endogenous hydrophobic bile salts.


CONCLUSIONS
Long-term treatment with low dose tauroursodeoxycholic acid after liver transplantation is safe but does not affect graft function and survival.
Angelico
M
M
Department of Surgery, University of Rome Tor Vergata, Italy. angelico@med.uniroma2.it
Tisone
G
G
Baiocchi
L
L
Palmieri
G
G
Pisani
F
F
Negrini
S
S
Anselmo
A
A
Vennarecci
G
G
Casciani
C U
CU
D000328:Adult; D001646:Bile / Q000737:chemistry / Q000187:drug effects; D017024:Chemotherapy, Adjuvant; D002756:Cholagogues and Choleretics / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D007536:Isomerism; D016031:Liver Transplantation / Q000502:physiology / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011182:Postoperative Care / Q000379:methods* / Q000706:statistics & numerical data; D013655:Taurochenodeoxycholic Acid / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors
D002756:Cholagogues and Choleretics; D007166:Immunosuppressive Agents; D013655:Taurochenodeoxycholic Acid; C031655:ursodoxicoltaurine