• Liver Transpl. · Jan 2005

    Randomized Controlled Trial Multicenter Study Clinical Trial

    Corticosteroid-free immunosuppression with tacrolimus following induction with daclizumab: a large randomized clinical study.

    • Olivier Boillot, David A Mayer, Karim Boudjema, Mauro Salizzoni, Bruno Gridelli, Franco Filipponi, Pavel Trunecka, Marek Krawczyk, Pierre-Alain Clavien, Christian Ducerf, Carlos Margarit, Raimund Margreiter, José Mir Pallardo, Krister Hoeckerstedt, and George-Phillipe Pageaux.
    • Service de Transplantation, Hôpital Edouard Herriot, Place D'Arsonval, 69437 Lyon Cedex 03, France. boillot@cismsun.univ-lyon1.fr
    • Liver Transpl. 2005 Jan 1; 11 (1): 61-7.

    AbstractThis open, randomized (1 : 1), multicenter, 3-month study compared a dual tacrolimus plus steroids (Tac / steroids) regimen with a steroid-free immunosuppressive regimen of tacrolimus following daclizumab induction therapy (Tac / Dac) in adult liver transplant recipients. The full analysis set comprised 347 patients in the Tac / steroids group and 351 in the Tac / Dac group. Mean tacrolimus dose during month 3 was 0.11 mg/kg/day in both groups; mean whole-blood trough levels during month 3 were 10.9 ng/mL (Tac / steroids) and 10.6 ng/mL (Tac / Dac). The incidence of biopsy-confirmed acute rejection that required treatment was similar in both groups: 26.5% in the Tac / steroids group and 25.4% in the Tac / Dac group (P = .727). However, the incidence of biopsy-confirmed corticosteroid-resistant acute rejection was higher in the Tac / steroids group than in the Tac / Dac group (6.3 vs. 2.8%; P = .027). Kaplan-Meier estimates of graft survival (92.2 vs. 90.5%) and patient survival (94.5 vs. 93.7%) were similar in both groups. While also the overall adverse event profiles were similar, the incidences of diabetes mellitus (15.3 vs. 5.7%, respectively; P < .001) and cytomegalovirus infection (11.5 vs. 5.1%, respectively; P = .002) were higher in the Tac / steroids group compared with the Tac / Dac group. Mean cholesterol levels increased by 16% in the Tac / steroids group, but were unchanged in the Tac / Dac group during the study. In conclusion, tacrolimus monotherapy following daclizumab induction is an effective and safe regimen, with an advantage over concomitant steroid-maintenance therapy in terms of a lower incidence of diabetes and viral infection, and a lower incidence of steroid-resistant acute rejection.

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