One-year pilot study on tauroursodeoxycholic acid as an adjuvant treatmentafter liver transplantation

Background. The usefulness of ursodeoxycholic acid after liver transplantat ion is controversial. Tauroursodeoxycholic acid, the natural taurine-amidat e, is a highly hydrophilic and cytoprotective bile salt currently under inv estigation. Aims. To investigate the clinical usefulness of tauroursodeoxycholic acid a fter liver transplantation. Patients. Thirty-three patients undergoing liver transplantation entered th e study. Methods. Sixteen patients were randomized to receive tauroursodeoxychodic a cid (250 b.i.d. for 12 months) and 17 served as controls. Tauroursodeoxycho lic acid was given from day 5 after transplantation for one year Results. Tauroursodeoxycholic acid treatment was safe and well tolerated. N o drop outs occurred. Among the 29 patients undergoing long-term follow-rep , Jive 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 cont rols (n.s.). No differences were observed with respect to early or late gra ft function and survival, nor to acute cellular rejection. Tauroursodeoxych olic acid therapy was associated with lower serum cholesterol levels (p<0.0 2) during the early postoperative months; with milder cholestasis; with a d rop in biliary cholates but no changes in endogenous hydrophobic bile salts . Conclusions. Long-term treatment with low dose tauroursodeoxycholic acid af ter liver transplantation is safe but does not affect graft function and su rvival.