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The Pittsburgh randomized trial of tacrolimus compared to cyclosporine for hepatic transplantation

Fung, JJ and Eliasziw, M and Todo, S and Jain, A and Demetris, AJ and McMichael, JP and Starzl, TE and Meier, P and Donner, A (1996) The Pittsburgh randomized trial of tacrolimus compared to cyclosporine for hepatic transplantation. Journal of the American College of Surgeons, 183 (2). 117 - 125. ISSN 1072-7515

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Abstract

BACKGROUND: Tacrolimus (formerly FK 506) was first used clinically in 1989 to successfully replace cyclosporine in hepatic transplant recipients who were experiencing intractable rejection or as the baseline drug from the time of operation. After extensive pilot experience, an institutional review board-mandated clinical trial comparing cyclosporine with tacrolimus was performed. STUDY DESIGN: From February 16, 1990 to December 26, 1991, 154 patients were recruited. The competing drugs were combined with equal induction doses of prednisone in both arms of the study for the first 81 patients and with subsequently higher doses of prednisone in the remaining 35 patients who received cyclosporine and were entered into the trial. Drug crossover was permitted for lack of efficacy or adverse events. End points were rejection confirmed by biopsy and treatment failure leading to retransplantation or death. RESULTS: Seventy-nine patients were randomized to the tacrolimus arm and 75 to the cyclosporine arm during 1990 and 1991. All patients were available for follow-up throughout the trial, which terminated on May 30, 1995. The mean duration of follow-up was four years. Patients randomized to the tacrolimus arm were less likely to experience acute rejection than were those receiving cyclosporine, with 36.2 percent of the patients receiving tacrolimus and 16.8 percent of the patients receiving cyclosporine showing freedom from rejection at one year (p=0.003, likelihood ratio test). Survival of patients over the course of the study was virtually the same in the two groups. CONCLUSIONS: Tacrolimus was more effective than cyclosporine in preventing acute rejection.


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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Fung, JJ
Eliasziw, M
Todo, S
Jain, A
Demetris, AJ
McMichael, JP
Starzl, TEtes11@pitt.eduTES11
Meier, P
Donner, A
Centers: Other Centers, Institutes, or Units > Thomas E. Starzl Transplantation Institute
Date: 1 August 1996
Date Type: Publication
Journal or Publication Title: Journal of the American College of Surgeons
Volume: 183
Number: 2
Page Range: 117 - 125
Institution: University of Pittsburgh
Refereed: Yes
ISSN: 1072-7515
Other ID: uls-drl:31735062126614, Starzl CV No. 1813
Date Deposited: 08 Apr 2010 17:30
Last Modified: 12 Oct 2017 08:57
URI: http://d-scholarship.pitt.edu/id/eprint/5199

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