A long-term comparison of tacrolimus (FK506) versus cyclosporine in liver transplantation: a report of the United States FK506 Study Group.
BACKGROUND
The long-term (5 year) efficacy and safety of tacrolimus (FK506) and cyclosporine were compared in primary liver transplant recipients who participated in a 1-year randomized, multicenter trial and a 4-year follow-up extension study.


METHODS
A total of 529 patients (263 tacrolimus group, 266 cyclosporine group) were randomized to study drug. Patients were evaluated at 3-month intervals. Patient and graft survival rates, incidence of adverse events, and changes in laboratory and clinical profiles were determined.


RESULTS
Cumulative 5-year patient and graft survival rates were comparable for the tacrolimus (79.0%, 71.8%) and cyclosporine (73.1%, 66.4%) groups. However, patient half-life survival was longer for tacrolimus-treated patients (25.1+/-5.1 years versus 15.2+/-2.5 years; P=0.049). Improved patient survival with tacrolimus was also observed for hepatitis C-positive patients (78.9% tacrolimus group versus 60.5% cyclosporine group; P=0.041). Both treatments were associated with a low incidence of late acute rejection, late steroid-resistant rejection, and death or graft loss related to rejection. Both treatments demonstrated an acceptable safety profile with maintenance of adequate renal and liver function and a low incidence of malignancy/lymphoproliferative disease and serious infections.


CONCLUSIONS
Tacrolimus is a safe and effective long-term maintenance immunosuppressive agent in primary liver transplantation.
Wiesner
R H
RH
Mayo Clinic, Rochester, Minnesota 55905, USA.
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007223:Infant; D016031:Liver Transplantation / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012086:Reoperation; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus