title: The Nordic multicenter double-blind randomized controlled trial of prophylactic ursodeoxycholic acid in liver transplant patients.
abstract: BACKGROUND
  Prophylactic treatment with ursodeoxycholic acid (UDCA) has been reported to reduce the incidence of acute rejection after liver transplantation compared with historical controls. We investigated this in a prospective, randomized, placebo-controlled multicenter study.
  
  
  METHODS
  Fifty-four liver transplant patients were allocated to the UDCA treatment group (15 mg/kg/day), and 48 patients were allocated to the placebo group. Trial medicine was started on the first postoperative day and was given for 3 months. Follow-up was for 12 months. Treatment was stratified for adults with chronic liver disease (n=77), adults with acute liver failure (n=10), and children (n=15).
  
  
  RESULTS
  The frequency of patients with acute rejection was 65% in the UDCA treatment group and 68% in the placebo group. The frequency of steroid-resistant rejection was similar in both groups. The probability of acute rejection, analyzed according to the intention-to-treat policy with Kaplan-Meier analysis, was similar in both treatment groups. No significant differences were found in patient survival and graft survival probabilities. For the biochemical markers of cholestasis, only gamma-glutamyltransferase was significantly improved after 2 months of UDCA treatment.
  
  
  CONCLUSIONS
  The initial optimistic report of a beneficial effect of prophylactic treatment with UDCA on acute rejection after liver transplantation was not confirmed in this controlled study.
authors.affiliation: Department of Medicine V and PET Centre, Aarhus University Hospital, Denmark.
authors.forename: S
authors.initials: S
authors.lastname: Keiding
authors.forename: K
authors.initials: K
authors.lastname: Høckerstedt
authors.forename: K
authors.initials: K
authors.lastname: Bjøro
authors.forename: S
authors.initials: S
authors.lastname: Bondesen
authors.forename: A
authors.initials: A
authors.lastname: Hjortrup
authors.forename: H
authors.initials: H
authors.lastname: Isoniemi
authors.forename: C
authors.initials: C
authors.lastname: Erichsen
authors.forename: G
authors.initials: G
authors.lastname: Söderdahl
authors.forename: B G
authors.initials: BG
authors.lastname: Ericzon
mesh_terms: D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001663:Bilirubin / Q000097:blood; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007223:Infant; D016031:Liver Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D007166:Immunosuppressive Agents; D014580:Ursodeoxycholic Acid; D016572:Cyclosporine; D005723:gamma-Glutamyltransferase; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin