Introduction. Long-term steroid administration may predispose liver transplant recipients to infectious and metabolic complication. Maintaining effective immunoprophylaxis while minimizing the negative consequences of steroid therapy could be a key factor in improving clinical outcomes.Methods. Six hundred two patients were randomized to receive tacrolimus (TAC) immunosuppression with a single-steroid bolus and two doses of daclizumab (DAC) or mycophenolate mofetil (MMF).Results. The incidence of biopsy-proven acute rejection was 19.7% in the TAC/DAC group and 16.2% in the TAC/ MMF group (ns). Three-month patient and graft survival were similar. Steroid use at month-3 was low at 5.5% in the TAC/DAC group and 3.9% in the TAC/MMF group. Significantly higher incidences of causally related adverse events (AEs) and significantly more dose modifications, interruptions, or discontinuations due to an AE were reported with TAC/MMF. Study withdrawal due to leucopenia was significantly higher with TAC/MMF (0.0% vs. 1.7%. P <= 0.05). AEs were generally reported less frequently in the TAC/DAC group. However, specifically headache and Supraventricular arrhythmia were significantly higher with TAC/DAC, whereas leucopenia and bacterial infection were significantly higher with TAC/MMF. Laboratory indices of renal function were similar, and increases in serum lipids were negligible in both groups. Incidences of de novo diabetes mellitus (>= 2 fasting plasma glucose values >= 7.0 mmol/L) were low at 9.5% (TAC/DAC) and 11.0% (TAC/MMF).Conclusion. Both TAC-based regimens allowed optimization of immunoprophylaxis while eliminating some of the negative consequences associated with steroids. Efficacy outcomes were comparable; however, TAC monotherapy after DAC induction was associated with significantly less leucopenia and less bacterial infection than a dual regimen incorporating MMF.

Becker, T., Foltys, D., Bilbao, I., D'Amico, D., Colledan, M., Bernardos, A., et al. (2008). Patient Outcomes in Two Steroid-Free Regimens Using Tacrolimus Monotherapy After Daclizumab Induction and Tacrolimus With Mycophenolate Mofetil in Liver Transplantation. TRANSPLANTATION, 86(12), 1689-1694 [10.1097/TP.0b013e31818fff64].

Patient Outcomes in Two Steroid-Free Regimens Using Tacrolimus Monotherapy After Daclizumab Induction and Tacrolimus With Mycophenolate Mofetil in Liver Transplantation

Colledan M;
2008

Abstract

Introduction. Long-term steroid administration may predispose liver transplant recipients to infectious and metabolic complication. Maintaining effective immunoprophylaxis while minimizing the negative consequences of steroid therapy could be a key factor in improving clinical outcomes.Methods. Six hundred two patients were randomized to receive tacrolimus (TAC) immunosuppression with a single-steroid bolus and two doses of daclizumab (DAC) or mycophenolate mofetil (MMF).Results. The incidence of biopsy-proven acute rejection was 19.7% in the TAC/DAC group and 16.2% in the TAC/ MMF group (ns). Three-month patient and graft survival were similar. Steroid use at month-3 was low at 5.5% in the TAC/DAC group and 3.9% in the TAC/MMF group. Significantly higher incidences of causally related adverse events (AEs) and significantly more dose modifications, interruptions, or discontinuations due to an AE were reported with TAC/MMF. Study withdrawal due to leucopenia was significantly higher with TAC/MMF (0.0% vs. 1.7%. P <= 0.05). AEs were generally reported less frequently in the TAC/DAC group. However, specifically headache and Supraventricular arrhythmia were significantly higher with TAC/DAC, whereas leucopenia and bacterial infection were significantly higher with TAC/MMF. Laboratory indices of renal function were similar, and increases in serum lipids were negligible in both groups. Incidences of de novo diabetes mellitus (>= 2 fasting plasma glucose values >= 7.0 mmol/L) were low at 9.5% (TAC/DAC) and 11.0% (TAC/MMF).Conclusion. Both TAC-based regimens allowed optimization of immunoprophylaxis while eliminating some of the negative consequences associated with steroids. Efficacy outcomes were comparable; however, TAC monotherapy after DAC induction was associated with significantly less leucopenia and less bacterial infection than a dual regimen incorporating MMF.
Articolo in rivista - Articolo scientifico
Safety outcomes; Steroid-free immunosuppression; Tacrolimus monotherapy;
English
1689
1694
6
Becker, T., Foltys, D., Bilbao, I., D'Amico, D., Colledan, M., Bernardos, A., et al. (2008). Patient Outcomes in Two Steroid-Free Regimens Using Tacrolimus Monotherapy After Daclizumab Induction and Tacrolimus With Mycophenolate Mofetil in Liver Transplantation. TRANSPLANTATION, 86(12), 1689-1694 [10.1097/TP.0b013e31818fff64].
Becker, T; Foltys, D; Bilbao, I; D'Amico, D; Colledan, M; Bernardos, A; Beckebaum, S; Isoniemi, H; Pirenne, J; Jaray, J
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/365620
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