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Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression

Todo, S and Fung, JJ and Starzl, TE and Tzakis, A and Doyle, H and Abu-Elmagd, K and Jain, A and Selby, R and Bronsther, O and Marsh, W and Ramos, H and Reyes, J and Gayowski, T and Casavilla, A and Dodson, F and Furukawa, H and Marino, I and Pinna, A and Nour, B and Jabbour, N and Mazanegos, G and McMichael, J and Kusne, S and Venkataramanan, R and Warty, V and Murase, N and Demetris, AJ and Iwatsuki, S (1994) Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression. Annals of Surgery, 220 (3). 297 - 309. ISSN 0003-4932

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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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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Todo, S
Fung, JJ
Starzl, TEtes11@pitt.eduTES11
Tzakis, A
Doyle, H
Abu-Elmagd, K
Jain, A
Selby, R
Bronsther, O
Marsh, W
Ramos, H
Reyes, J
Gayowski, T
Casavilla, A
Dodson, F
Furukawa, H
Marino, I
Pinna, A
Nour, B
Jabbour, N
Mazanegos, G
McMichael, J
Kusne, S
Venkataramanan, R
Warty, V
Murase, N
Demetris, AJ
Iwatsuki, S
Centers: Other Centers, Institutes, Offices, or Units > Thomas E. Starzl Transplantation Institute
Date: 1 January 1994
Date Type: Publication
Journal or Publication Title: Annals of Surgery
Volume: 220
Number: 3
Page Range: 297 - 309
DOI or Unique Handle: 10.1097/00000658-199409000-00006
Institution: University of Pittsburgh
Refereed: Yes
ISSN: 0003-4932
Other ID: uls-drl:31735062124692, Starzl CV No. 1653
Date Deposited: 08 Apr 2010 17:28
Last Modified: 03 Feb 2019 02:55


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