EFFICACY AND SAFETY OF TACROLIMUS COMPARED WITH CYCLOSPORINE MICROEMULSION IN PRIMARY SIMULTANEOUS PANCREAS-KIDNEY TRANSPLANTATION: 1-YEAR RESULTS OF A LARGE MULTICENTER TRIAL :
(2004) Transplantation — Vol. 77, n° 8, p. 1221-1228 (2004)
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- Background: Simultaneous pancreas-kidney transplantation (SPK) transplantation has become an accepted therapy for type 1 diabetic patients with end-stage renal disease. This open-label, multicenter study compared the efficacy and safety of tacrolimus with the microemulsion (ME) formulation of cyclosporine in a clinical setting. The 1-year results are reported here. Methods: The study was conducted in 10 European centers and one center in Israel. One hundred three patients were randomly assigned to tacrolimus and 102 to cyclosporine-ME. All patients received concomitant rabbit anti-T-cell globulin induction therapy, mycophenolate mofetil (MMF), and short-term cortico-steroids. The initial daily oral doses were 0.2 mg/kg for tacrolimus, 7 mg/kg for cyclosporine-ME, and 2 to 3 g for MMF. Results: The 1-year incidence of biopsy-proven kidney or pancreas acute rejection was lower with tacrolimus (27.2%) than with cyclosporine-ME (38.2%; P = 0.09). Pancreas graft survival at 1 year was 91.3% with tacrolimus and 74.5% with cyclosporine-ME (P <0.0005). Renal graft survival was similar in the two study groups. There were no significant treatment-related differences in pancreatic or renal graft function. In total, 34 patients switched treatment from cyclosporine-ME to tacrolimus, but only 6 patients receiving tacrolimus required alternative therapy. Mean doses of MMF at 1 year were also lower in the tacrolimus group (1.36 vs. 1.67 g/day; P = 0.007). Conclusion: These findings support the use of tacrolimus therapy for uremic patients with type 1 diabetes who are undergoing SPK transplantation.
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Bechstein, W. O., Malaise, J., Saudek, F., Land, W., Fernandez-Cruz, L., Margreiter, R., Nakache, R., Secchi, A., Vanrenterghem, Y., Tydén, G., Van Ophem, D., Berney, T., Boucek, P., Landgraf, R., Kahl, A., & Squifflet, J.-P. (2004). EFFICACY AND SAFETY OF TACROLIMUS COMPARED WITH CYCLOSPORINE MICROEMULSION IN PRIMARY SIMULTANEOUS PANCREAS-KIDNEY TRANSPLANTATION: 1-YEAR RESULTS OF A LARGE MULTICENTER TRIAL : Transplantation, 77(8), 1221-1228. https://doi.org/10.1097/01.tp.0000120865.96360.df (Original work published 2004)