THE NORDIC MULTICENTER DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL OF PROPHYLACTIC URSODEOXYCHOLIC ACID IN LIVER-TRANSPLANT PATIENTS

Citation
S. Keiding et al., THE NORDIC MULTICENTER DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL OF PROPHYLACTIC URSODEOXYCHOLIC ACID IN LIVER-TRANSPLANT PATIENTS, Transplantation, 63(11), 1997, pp. 1591-1594
Citations number
17
Categorie Soggetti
Immunology,Surgery,Transplantation
Journal title
ISSN journal
00411337
Volume
63
Issue
11
Year of publication
1997
Pages
1591 - 1594
Database
ISI
SICI code
0041-1337(1997)63:11<1591:TNMDRC>2.0.ZU;2-Q
Abstract
Background. Prophylactic treatment with ursodeoxycholic acid (UDCA) ha s been reported to reduce the incidence of acute rejection after liver transplantation compared with historical controls. We investigated th is in a prospective, randomized, placebo-controlled multicenter study. Methods. Fifty-four liver transplant patients were allocated to the U DCA treatment group (15 mg/kg/ day), and 48 patients were allocated to the placebo group. Trial medicine was started on the first postoperat ive day and was given for 3 months. Follow-up was for 12 months. Treat ment was stratified for adults with chronic liver disease (n=77), adul ts with acute liver failure (n=10), and children (n=15). Results. The frequency of patients with acute rejection was 65% in the UDCA treatme nt group and 68% in the placebo group. The frequency of steroid-resist ant rejection was similar in both groups. The probability of acute rej ection, analyzed according to the intention-to-treat policy with Kapla n-Meier analysis, was similar in both treatment groups. No significant differences were found in patient survival and graft survival probabi lities. For the biochemical markers of cholestasis, only gamma-glutamy ltransferase was significantly improved after 2 months of UDCA treatme nt. Conclusions. The initial optimistic report of a beneficial effect of prophylactic treatment with UDCA on acute rejection after liver tra nsplantation was not confirmed in this controlled study.