In a 24-month prospective, randomized, multicenter, open-label study, de novo liver transplant patients were randomized at 30 days to everolimus (EVR) + Reduced tacrolimus (TAC; n = 245), TAC Control (n = 243) or TAC Elimination (n = 231). Randomization to TAC Elimination was stopped prematurely due to a significantly higher rate of treated biopsy-proven acute rejection (tBPAR). The incidence of the primary efficacy endpoint, composite efficacy failure rate of tBPAR, graft loss or death postrandomization was similar with EVR + Reduced TAC (10.3%) or TAC Control (12.5%) at month 24 (difference -2.2%, 97.5% confidence interval [CI] -8.8%, 4.4%). BPAR was less frequent in the EVR + Reduced TAC group (6.1% vs. 13.3% in TAC Control, p = 0.010). Adjusted change in estimated glomerular filtration rate (eGFR) from randomization to month 24 was superior with EVR + Reduced TAC versus TAC Control: difference 6.7 mL/min/1.73 m 2 (97.5% CI 1.9, 11.4 mL/min/1.73 m2, p = 0.002). Among patients who remained on treatment, mean (SD) eGFR at month 24 was 77.6 (26.5) mL/min/1.73 m2 in the EVR + Reduced TAC group and 66.1 (19.3) mL/min/1.73 m2 in the TAC Control group (p < 0.001). Study medication was discontinued due to adverse events in 28.6% of EVR + Reduced TAC and 18.2% of TAC Control patients. Early introduction of everolimus with reduced-exposure tacrolimus at 1 month after liver transplantation provided a significant and clinically relevant benefit for renal function at 2 years posttransplant. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons

Saliba, F., De Simone, P., Nevens, F., DE CARLIS, L., Metselaar, H., Beckebaum, S., et al. (2013). Renal function at two years in liver transplant patients receiving everolimus: Results of a randomized, multicenter study. AMERICAN JOURNAL OF TRANSPLANTATION, 13(7), 1734-1745 [10.1111/ajt.12280].

Renal function at two years in liver transplant patients receiving everolimus: Results of a randomized, multicenter study

DE CARLIS, LUCIANO GREGORIO;
2013

Abstract

In a 24-month prospective, randomized, multicenter, open-label study, de novo liver transplant patients were randomized at 30 days to everolimus (EVR) + Reduced tacrolimus (TAC; n = 245), TAC Control (n = 243) or TAC Elimination (n = 231). Randomization to TAC Elimination was stopped prematurely due to a significantly higher rate of treated biopsy-proven acute rejection (tBPAR). The incidence of the primary efficacy endpoint, composite efficacy failure rate of tBPAR, graft loss or death postrandomization was similar with EVR + Reduced TAC (10.3%) or TAC Control (12.5%) at month 24 (difference -2.2%, 97.5% confidence interval [CI] -8.8%, 4.4%). BPAR was less frequent in the EVR + Reduced TAC group (6.1% vs. 13.3% in TAC Control, p = 0.010). Adjusted change in estimated glomerular filtration rate (eGFR) from randomization to month 24 was superior with EVR + Reduced TAC versus TAC Control: difference 6.7 mL/min/1.73 m 2 (97.5% CI 1.9, 11.4 mL/min/1.73 m2, p = 0.002). Among patients who remained on treatment, mean (SD) eGFR at month 24 was 77.6 (26.5) mL/min/1.73 m2 in the EVR + Reduced TAC group and 66.1 (19.3) mL/min/1.73 m2 in the TAC Control group (p < 0.001). Study medication was discontinued due to adverse events in 28.6% of EVR + Reduced TAC and 18.2% of TAC Control patients. Early introduction of everolimus with reduced-exposure tacrolimus at 1 month after liver transplantation provided a significant and clinically relevant benefit for renal function at 2 years posttransplant. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons
Articolo in rivista - Articolo scientifico
Everolimus; glomerular filtration rate; mTOR inhibitors; renal function; tacrolimus; Adolescent; Adult; Aged; Antineoplastic Agents; Dose-Response Relationship, Drug; Europe; Everolimus; Female; Follow-Up Studies; Glomerular Filtration Rate; Graft Rejection; Graft Survival; Humans; Immunosuppressive Agents; Incidence; Kidney; Male; Middle Aged; North America; Prospective Studies; Sirolimus; South America; Treatment Outcome; Young Adult; Liver Transplantation; Transplantation; Immunology and Allergy; Pharmacology (medical)
English
1734
1745
12
Saliba, F., De Simone, P., Nevens, F., DE CARLIS, L., Metselaar, H., Beckebaum, S., et al. (2013). Renal function at two years in liver transplant patients receiving everolimus: Results of a randomized, multicenter study. AMERICAN JOURNAL OF TRANSPLANTATION, 13(7), 1734-1745 [10.1111/ajt.12280].
Saliba, F; De Simone, P; Nevens, F; DE CARLIS, L; Metselaar, H; Beckebaum, S; Jonas, S; Sudan, D; Fischer, L; Duvoux, C; Chavin, K; Koneru, B; Huang, M; Chapman, W; Foltys, D; Dong, G; Lopez, P; Fung, J; Junge, G
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/101015
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