Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/66047
Type: Artigo de periódico
Title: Everolimus with optimized cyclosporine dosing in renal transplant recipients: 6-month safety and efficacy results of two randomized studies
Author: Vitko, S
Tedesco, H
Eris, J
Pascual, J
Whelchel, J
Magee, JC
Campbell, S
Civati, G
Bourbigot, B
Alves, G
Leone, J
Garcia, VD
Rigotti, P
Esmeraldo, R
Cambi, V
Haas, T
Jappe, A
Bernhardt, P
Geissler, J
Cretin, N
Abstract: Two prospective, randomized studies evaluated everolimus 1.5 vs. 3 mg/day with steroids and low-exposure cyclosporine (CsA) (C-2 monitoring) in de novo renal transplant patients. Everolimus dosing was adjusted to maintain a minimum trough level of 3 ng/mL. Study 1 (A2306; n = 237) had no induction therapy; in Study 2 (A2307; n = 256) basiliximab was administered (Days 0 and 4). The primary endpoint was renal function at 6 months. CsA C-2 target levels, initially 1200 ng/mL in Study 1 and 600 ng/mL in Study 2, were tapered over time post-transplant. Median creatinine levels in Study 1 were 133 and 132 mumol/L at 6 months in the 1.5 and 3 mg/day groups, respectively, and 130 mumol/L in both groups in Study 2. Biopsy-proven acute rejection (BPAR) occurred in 25.0% and 15.2% of patients in the 1.5 and 3 mg/day groups in Study 1, and 13.7% and 15.1% in Study 2. Incidence of BPAR was significantly higher in patients with an everolimus trough < 3 ng/mL. There were no significant between-group differences in the composite endpoint of BPAR, graft loss or death, nor any significant between-group differences in adverse events in either study. Concentration-controlled everolimus with low-exposure CsA provided effective protection against rejection with good renal function.
Subject: cyclosporine
everolimus
immunosuppressive regimen
renal function
therapeutic drug monitoring
transplantation
Country: Dinamarca
Editor: Blackwell Munksgaard
Rights: fechado
Identifier DOI: 10.1111/j.1600-6143.2004.00389.x
Date Issue: 2004
Appears in Collections:Unicamp - Artigos e Outros Documentos

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