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A randomized clinical trial of ursodeoxycholic acid as adjuvant treatment to prevent liver transplant rejection
Author(s) -
Barnes D,
Talenti D,
Cammell G,
Goormastic M,
Farquhar L,
Henderson M,
Vogt D,
Mayes J,
Westveer M K,
Carey W
Publication year - 1997
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510260408
Subject(s) - medicine , ursodeoxycholic acid , regimen , gastroenterology , incidence (geometry) , placebo , randomized controlled trial , liver transplantation , transplantation , clinical trial , surgery , physics , alternative medicine , pathology , optics
Acute rejection following orthotopic liver transplantation is a common problem despite current immunosuppressive regimens. Ursodeoxycholic acid (UDCA) has been shown in small, open‐labeled studies to prevent rejection episodes, although its effects on complications such as infections, length of hospital stay, and survival have not been evaluated. We conducted a randomized, placebo‐controlled, double‐blind trial to determine if UDCA (10‐15 mg/kg/d) added to a cyclosporine‐based immunosuppressive regimen was associated with a decrease in the incidence of at least one episode of acute cellular rejection. Secondary end‐points included determining differences in the total number of rejection episodes, 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 group. During the 3 months of the trial, there was no difference between the placebo and UDCA groups in the number of patients who were rejection‐free; however, there were significantly fewer patients in the treatment group who had multiple episodes of acute rejection (0 vs. 6; P = .007). Patients in the treatment group experienced a significantly lower incidence of bacterial infections (4% vs. 29%; P = .02), shorter hospital 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 addition of UDCA to a cyclosporine‐based immunosuppressive regimen results in significantly fewer patients experiencing multiple episodes of rejection and improved survival at 90 days and at 1 year. The use of UDCA as adjuvant therapy for patients undergoing liver transplantation who are treated with a cyclosporine‐based immunosuppressive regimen should be considered.