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
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.