Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression.
OBJECTIVE
The efficacy for primary orthotopic liver transplantation of a new immunosuppressive agent, FK 506 (tacrolimus, Prograf, Fujisawa USA, Deerfield, IL), was determined.


BACKGROUND
After 3 years of preclinical research, a clinical trial of FK 506 for orthotopic liver transplantation was begun in February 1989, first as a rescue therapy for patients with intractable rejection with conventional immunosuppression, then as a primary drug.


METHODS
Between August 1989 and December 1993, 1391 recipients (1188 adult and 203 pediatric) of primary liver allografts were treated with FK 506 from the outset. Results from these patients were analyzed and compared with those of 1212 historical control patients (971 adult and 241 pediatric) given cyclosporine-based immunosuppression.


RESULTS
Actuarial survival at 4 years was 86.2% with FK 506 versus 65.5% with cyclosporine in the pediatric patients (p < 0.0000) and 71.4% versus 65.5% in the adults (p < 0.0005). The need for retransplantation was reduced significantly for FK 506 patients. Four-year graft survival was 77.0% with FK 506 versus 48.4% with cyclosporine in the pediatric patients (p < 0.0000), and 61.9% with FK 506 versus 51.4% with cyclosporine in the adult recipients (p < 0.0000). Regression analysis revealed that reduction in mortality or graft loss from uncontrollable rejection, sepsis, technical failure, and recurrent original liver disease were responsible for the improved results with FK 506 therapy.


CONCLUSIONS
FK 506 is a potent and superior immunosuppressive agent for orthotopic liver transplantation.
Todo
S
S
Pittsburgh Transplant Institute, University of Pittsburgh Medical Center, Pennsylvania.
Fung
J J
JJ
Starzl
T E
TE
Tzakis
A
A
Doyle
H
H
Abu-Elmagd
K
K
Jain
A
A
Selby
R
R
Bronsther
O
O
Marsh
W
W
D000206:Actuarial Analysis; D000328:Adult; D002423:Cause of Death; D002648:Child; D016572:Cyclosporine / Q000627:therapeutic use; D005500:Follow-Up Studies; D006085:Graft Survival; D006801:Humans; D007165:Immunosuppression Therapy; D015994:Incidence; D007223:Infant; D016031:Liver Transplantation / Q000401:mortality; D012044:Regression Analysis; D012086:Reoperation / Q000706:statistics & numerical data; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*
D016572:Cyclosporine; D016559:Tacrolimus