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Prepublished online as a Blood First Edition Paper on May 24, 2002; DOI 10.1182/blood-2001-12-0159.
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Blood, 15 September 2002, Vol. 100, No. 6, pp. 1977-1983
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Ursodeoxycholic acid for the prevention of hepatic
complications in allogeneic stem cell transplantation
Tapani Ruutu,
Britta Eriksson,
Kari Remes,
Eeva Juvonen,
Liisa Volin,
Mats Remberger,
Terttu Parkkali,
Hans Hägglund, and
Olle Ringdén for the Nordic Bone Marrow
Transplantation Group
From the Department of Medicine, Helsinki University
Central Hospital, Helsinki, Finland; Centre for Allogeneic Stem Cell
Transplantation, Department of Clinical Immunology, and Department of
Medicine, Huddinge University Hospital, Huddinge, Sweden; and
Department of Medicine, Turku University Hospital, Turku, Finland.
The role of ursodeoxycholic acid (UDCA) in the prevention of
hepatic complications after allogeneic stem cell transplantation was
studied in a prospective randomized open-label multicenter trial. A
total of 242 patients were allocated to receive (n = 123) or not to
receive (n = 119) UDCA in the dose of 12 mg/kg/d orally from the day
preceding the conditioning until day 90 after transplantation. In the
UDCA-treated group a significantly smaller proportion of patients
developed a serum bilirubin level exceeding 50 µM (18 of 123 versus
31 of 119, P = .04), and similarly a smaller proportion
of patients exceeded the alanine aminotransferase level of 100 U/L.
There was no difference in the incidence of veno-occlusive disease of
the liver. Compared to the control group, in the UDCA-treated group
there was a nonsignificant trend toward a lower overall incidence of
acute graft-versus-host disease (GVHD) and a significantly lower
incidence of grade III to IV acute GVHD (5 of 123 versus 17 of 119, P = .01), stage II to IV liver and intestinal GVHD, and
stage III to IV skin GVHD. There was no difference in
the incidence of chronic GVHD or in the relapse rate. Among the
patients given UDCA, the survival at 1 year was significantly better,
71% versus 55% (P = .02), and the nonrelapse mortality
rate was lower, 19% versus 34% (P = .01), than in the
control group. There were significantly more deaths in GVHD in the
control group. In conclusion, UDCA administration reduced hepatic
problems and severe acute GVHD and improved survival. These results
suggest a role for UDCA in the prevention of transplant-related
complications in allogeneic transplantation.
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