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

Journal of the American College of Surgeons

Volumn 183, Issue 2, 1996, Pages 117-125

  Fung, John J ^a,d   Eliasziw, Michael ^b   Todo, Satoru ^a   Jain, Ashok ^a   Demetris, Anthony J ^a   McMichael, John P ^a   Starzl, Thomas E ^a   Meier, Paul ^c   Donner, Allan ^b  

^a UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^b UNIVERSITY OF WESTERN ONTARIO   (Canada)

^c Columbia University ^*  (United States)

^d UNIVERSITY OF PITTSBURGH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN; TACROLIMUS;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; GRAFT REJECTION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL; TREATMENT FAILURE; TREATMENT OUTCOME;

ADOLESCENT; ADULT; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER DISEASES; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; PREDNISONE; TACROLIMUS; TREATMENT OUTCOME;

EID: 0029761197     PISSN: 10727515     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (41)

1. Pollock, A. V. The rise and fall of the random controlled trial in surgery. Theor. Surg., 1989, 4: 163-170.
2. Solomon, M. J., McLeod, R. S., Laxamana, A., and Devore, L. Randomized controlled trials in surgery. Surgery, 1994, 115: 707-712.
3. Solomon, M. J., and McLeod, R. S. Should we be performing more randomized controlled trials evaluating surgical operations? Surgery, 1995, 118: 459-467.
4. Starzl, T. E., Todo, S., Fung, J., and others. FK 506 for human liver, kidney and pancreas transplantation. Lancet, 1989, 2: 1000-1004.
5. Fung, J. J., Todo, S., Jain, A., and others. Conversion of liver allograft recipients with cyclosporine related complications from cyclosporine to FK 506. Transplant. Proc., 1990, 22: 6-12.
6. Fung, J. J., Todo, S., Tzakis, A., and others. Conversion of liver allograft recipients from cyclosporine to FK506-based immunosuppression: benefits and pitfalls. Transplant. Proc., 1991, 23: 14-21.
7. Starzl, T. E., Fung, J., Jordan, M., and others. Kidney transplantation under FK 506. J. A. M. A., 1990, 264: 63-67.
8. Todo, S., Fung, J. J., Starzl, T. E., and others. Liver, kidney, and thoracic organ transplantation under FK 506. Ann. Surg., 1990, 212: 295-305.
9. Armitage, J. M., Kormos, R. L., Griffith, B. P., and others. The clinical trial of FK 506 as primary and rescue immunosuppression in cardiac transplantation. Transplant. Proc., 1991, 23: 1149-1152.
10. Shapiro, R., Jordan, M., Fung, J., and others. Kidney transplantation under FK 506 immunosuppression. Transplant. Proc., 1991, 23: 920-923.
11. The European FK 506 Multicentre Liver Study Group (Neuhaus, P., Pichlmayr, R., and Williams, R.): Randomised trial comparing tacrolimus (FK 506) and cyclosporin in prevention of liver allograft rejection. Lancet, 1994, 344: 423-428.
12. The U.S. Multicenter FK 506 Liver Study Group (Klintmalm, G.): A comparison of tacrolimus (FK 506) and cyclosporine for immunosuppression in liver transplantation. N. Engl. J. Med., 1994, 331: 1110-1115.
13. Fung, J., Abu-Elmagd, K., Jain, A., and others. A randomized trial of primary liver transplantation under immunosuppression with FK 506 vs cyclosporine. Transplant. Proc., 1991, 23: 2977-2983.
14. Porter, K. A. Pathology of the orthotopic homograft and heterograft. In: Experience in Hepatic Transplantation. Edited by T. E. Starzl. Pp. 464-465. Philadelphia: W. B. Saunders Co., 1969.
15. Starzl, T. E., and Demetris, A. J. Liver transplantation: a 31 year perspective. In : Current Problems in Surgery Classic. Pp. 85-99, 101-115. Chicago: Year Book Medical Publishers, 1990.
16. Demetris, A. J., Fung, J. J., Todo, S., and others. Conversion of liver allograft recipients from cyclosporine to FK 506 immunosuppressive therapy: a clinicopathologic study of 96 patients. Transplantation, 1992, 53: 1056-1062.
17. McCauley, J., Takaya, S., Fung, J., and others. The question of FK 506 nephrotoxicity after liver transplantation. Transplant. Proc., 1991, 23: 1444-1447.
18. Starzl, T. E., and Fung, J. J. Contempo 90: transplantation. J. A. M. A., 1990, 263: 2686-2687.
19. Abu-Elmagd, K., Fung, J. J., Alessiani, M., and others. The effect of graft function on FK506 plasma levels, doses, and renal function, with particular reference to the liver. Transplantation, 1991, 52: 71-77.
20. Venkataramanan, R., Jain, A., Warty, V. W., and others. Pharmacokinetics of FK 506 following oral administration: a comparison of FK 506 and cyclosporine. Transplant. Proc., 1991, 23: 931-933.
21. Tamura, K., Kobayashi, M., Hashimoto, K., and others. A highly sensitive method to assay FK 506 levels in plasma. Transplant. Proc., 1987, Suppl. 6, 19: 23-29.
22. Starzl, T. E., Hakala, T. R., Rosenthal, J. T., and others. Variable convalescence and therapy after cadaveric renal transplantation under cyclosporin A and steroids. Surg. Gynecol. Obstet., 1982, 154: 819-825.
23. Plebani, M., Paleari, C. D., Masiero, M., and others. Fluorescence polarization immunoassay for cyclosporine. A determination in whole blood. Ther. Drug Monit, 1990, 12: 284-287.
24. Starzl, T. E., Abu-Elmagd, K, Tzakis, A., and others. Selected topics on FK 506: with special references to rescue of extrahepatic whole organ grafts, transplantation of "forbidden organs," side effects, mechanisms, and practical pharmacokinetics. Transplant. Proc., 1991, 23: 914-919.
25. Mieles, L., Gordon, R. D., Mintz, D., and others. Glycemia and insulin need following FK 506 rescue therapy in liver transplant recipients. Transplant. Proc., 1991, 23: 949-953.
26. Kusne, S., Fung, J., Alessiani, M., and others. Infections during a randomized trial comparing cyclosporine to FK 506 immunosuppression in liver transplantation. Transplant. Proc., 1992, 24: 429-430.
27. Alessiani, M., Kusne, S., Martin, M., and others. Infections in adult liver transplant patients under FK506 immunosuppression. Transplant. Proc., 1991, 23: 1501-1503.
28. Jain, A. B., Fung, J. J., Todo, S., and others. Incidence and treatment of rejection episodes in primary orthotopic liver transplantation under FK506. Transplant. Proc., 1991, 23: 928-930.
29. Cox, D. R., and Snell, E. J. Analysis of Binary Data. 2nd ed. London: Chapman and Hall, 1989.
30. Murray, J. E., Merrill, J. P., Dammin, G. J., and others. Kidney transplantation in modified recipients. Ann. Surg., 1962, 156: 337-355.
31. Murray, J. E., Merrill, J. P., Harrison, J. H., and others. Prolonged survival of human-kidney homografts by immunosuppressive drug therapy. N. Engl. J. Med., 1963, 268: 1315-1323.
32. Starzl, T. E., Marchioro, T. L., and Waddell, W. R. The reversal of rejection in human renal homografts with subsequent development of homograft tolerance. Surg. Gynecol. Obstet., 1963, 117: 385-395.
33. Starzl, T. E., Marchioro, T. L., Porter, K. A., and others. The use of heterologous antilymphoid agents in canine renal and liver homotransplantation and in human renal homotransplantation. Surg. Gynecol. Obstet., 1967, 124: 301-318.
34. Calne, R. Y., Rolles, K., Thiru, S., and others. Cyclosporin A initially as the only immunosuppressant in 34 patients of cadaveric organs: 32 kidneys, 2 pancreas, and 2 livers. Lancet, 1979, 2: 1033-1036.
35. Starzl, T. E., Weil III, R., Iwatsuki, S., and others. The use of cyclosporin A and prednisone in cadaver kidney transplantation. Surg. Gynecol. Obstet., 1980, 151: 17-26.
36. Letter in a Birmingham Jail. In: The Puzzle People. Edited T. E. Starzl. Pp. 231-242. Pittsburgh: University of Pittsburgh Press, 1992.
37. Starzl, T. E., Donner, A., Elasziw, M., and others. Randomized trialomania? The multicenter liver transplant trials. Lancet, 1995, 346: 1346-1350.
38. Warty, V., Zuckerman, S., Venkataramanan, R., and others. Tacrolimus analysis: a comparison of different methods and matrices. Ther. Drug Monit., 1995, 17: 159-167.
39. Gjertson, D. W., Cecka, J. M., and Terasaki, P. I. The relative effects of FK 506 and cyclosporine on short- and long-term kidney graft survival. Transplantation, 1995, 60: 1384-1388.
40. Griffith, B. P., Bando, K., Hardesty, R. L., and others. Prospective randomized trial of FK 506 versus cyclosporine after human pulmonary transplantation. Transplantation, 1994, 57: 848-851.
41. Pham, S. I., Kormos, R. L., Hattler, B. G., and others. A prospective trial of tacrolimus (FK 506) in clinical heart transplantation: intermediate term results. J. Thorac. Cardiovasc. Surg., 1996, 111: 764-772.