TY - JOUR
T1 - Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression
AU - Todo, Satoru
AU - Fung, John J.
AU - Starzl, Thomas E.
AU - Tzakis, Andreas
AU - Doyle, Howard
AU - Abu-Elmagd, Kareem
AU - Jain, Ashok
AU - Selby, Rick
AU - Bronsther, Oscar
AU - Marsh, Wallis
AU - Ramos, Hector
AU - Reyes, Jorge
AU - Gayowski, Timothy
AU - Casavilla, Adrian
AU - Dodson, Forrest
AU - Furukawa, Hiroyuki
AU - Marino, Ignazio
AU - Pinna, Antonio
AU - Nour, Bakr
AU - Jabbour, Nicholas
AU - Mazanegos, George
AU - McMichael, John
AU - Kusne, Shimon
AU - Venkataramanan, Raman
AU - Warty, Vijay
AU - Murase, Noriko
AU - Demetris, Anthony J.
AU - Iwatsuki, Shunzaburo
PY - 1994/9
Y1 - 1994/9
N2 - Objective: The efficacy for primary orthotopic liver transplantation of a new immunosuppressive agent, FK 506 (tacrolimus, Prograf, Fujisawa USA, Deerfield, IL), was determined. Summary Background Data: 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 reductions 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.
AB - Objective: The efficacy for primary orthotopic liver transplantation of a new immunosuppressive agent, FK 506 (tacrolimus, Prograf, Fujisawa USA, Deerfield, IL), was determined. Summary Background Data: 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 reductions 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.
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U2 - 10.1097/00000658-199409000-00006
DO - 10.1097/00000658-199409000-00006
M3 - Article
C2 - 7522431
AN - SCOPUS:0028073264
SN - 0003-4932
VL - 220
SP - 297
EP - 309
JO - Annals of surgery
JF - Annals of surgery
IS - 3
ER -