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Title: Renal function at two years in liver transplant patients receiving everolimus: results of a randomized, multicenter study
Authors: Saliba, F ×
De Simone, P
Nevens, Frederik
De Carlis, L
Metselaar, H J
Beckebaum, S
Jonas, S
Sudan, D
Fischer, L
Duvoux, C
Chavin, K D
Koneru, B
Huang, M A
Chapman, W C
Foltys, D
Dong, G
Lopez, P M
Fung, J
Junge, G
H2304 Study Group #
Issue Date: Jul-2013
Publisher: Munksgaard International Publishers
Series Title: American Journal of Transplantation vol:13 issue:7 pages:1734-45
Article number: 10.1111/ajt.12280
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 m(2) , p = 0.002). Among patients who remained on treatment, mean (SD) eGFR at month 24 was 77.6 (26.5) mL/min/1.73 m(2) in the EVR + Reduced TAC group and 66.1 (19.3) mL/min/1.73 m(2) 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.
ISSN: 1600-6135
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Hepatology
× corresponding author
# (joint) last author

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