A RANDOMIZED CLINICAL-TRIAL OF URSODEOXYCHOLIC ACID AS ADJUVANT TREATMENT TO PREVENT LIVER-TRANSPLANT REJECTION

Acute rejection following orthotopic liver transplantation is a common problem despite current immunosuppressive regimens. Ursodeoxycholic a cid (UDCA) has been shown in small, open-labeled studies to prevent re jection episodes, although its effects on complications such as infect ions, length of hospital stay, and survival have not been evaluated. W e conducted a randomized, placebo-controlled, double-blind trial to de termine if UDCA (10-15 mg/kg/d) added to a cyclosporine-based immunosu ppressive regimen was associated with a decrease in the incidence of a t least one episode of acute cellular rejection. Secondary end-paints included determining differences in the total number of rejection epis odes, the use of muromonab-CD3, the incidence of infections, length of hospital stay, and survival at 90 days and 1 year, Fifty-two patients were randomized, 28 to the treatment group and 24 to the placebo grou p. During the 3 months of the trial, there was no difference between t he placebo and UDCA groups in the number of patients who were rejectio n-free; however, there were significantly fewer patients in the treatm ent group who had multiple episodes of acute rejection (0 vs. 6; P = . 007). Patients in the treatment group experienced a significantly lowe r incidence of bacterial infections (4% vs. 29%; P = .02), shorter hos pital stay (25 days vs, 34 days; P = .03), and better 90-day survival (100% vs. 83%; P = .04) and 1-year survival (93% vs. 79%). The additio n of UDCA to a cyclosporine-based immunosuppressive regimen results in significantly fewer patients experiencing multiple episodes of reject ion and improved survival at 90 days and at 1 year, The use of UDCA as adjuvant therapy for patients undergoing liver transplantation who ar e treated with a cyclosporine-based immunosuppressive regimen should b e considered.