A long-term comparison of tacrolimus (FK506) versus cyclosporine in liver transplantation. A report of the United States FK506 study group

Russell H. Wiesner, R. W. Busttil, S. McDiarmid, G. B. Klintmalm, R. Goldstein, C. M. Miller, M. Schwartz, B. W. Shaw, J. P. Roberts, M. F. Herbert, C. O. Esquivel, P. Nakazato, R. A.F. Krom, M. Kalayoglu, A. M. D'Alessandro, J. W. Marsh, M. G. Peters, J. Burdick, A. Klein, W. D. LewisR. Jenkins, J. R. Thistlethwaite, J. C. Edmod, S. Gadgil, D. P. Facklam

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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.

Original languageEnglish (US)
Pages (from-to)493-499
Number of pages7
Issue number4
StatePublished - Aug 27 1998


ASJC Scopus subject areas

  • Transplantation

Cite this

Wiesner, R. H., Busttil, R. W., McDiarmid, S., Klintmalm, G. B., Goldstein, R., Miller, C. M., Schwartz, M., Shaw, B. W., Roberts, J. P., Herbert, M. F., Esquivel, C. O., Nakazato, P., Krom, R. A. F., Kalayoglu, M., D'Alessandro, A. M., Marsh, J. W., Peters, M. G., Burdick, J., Klein, A., ... Facklam, D. P. (1998). A long-term comparison of tacrolimus (FK506) versus cyclosporine in liver transplantation. A report of the United States FK506 study group. Transplantation, 66(4), 493-499. https://doi.org/10.1097/00007890-199808270-00014