Safety and Efficacy of the Early Introduction of Everolimus (Certican(R)) with Low Dose of Cyclosporine in de Novo Kidney Recipients after 1 Month of Transplantation (Preliminary Results) / 대한이식학회지
The Journal of the Korean Society for Transplantation
; : 83-91, 2012.
Artigo
em Coreano
| WPRIM (Pacífico Ocidental)
| ID: wpr-97410
Biblioteca responsável:
WPRO
ABSTRACT
BACKGROUND:
Everolimus and cyclosporine (CsA) exhibit synergistic immunosuppressive activity when used in combination. We analyzed preliminary data about the use of everolimus with a CsA-sparing strategy in de novo renal transplant recipients.METHODS:
A comparative, parallel, randomized, open-label, 1 year study has been performed in 117 patients from 5 transplant centers to compare the efficacy and tolerability of everolimus (EVE)+reduced-dose CsA or enteric-coated mycophenolate sodium (Myfortic)+standard-dose CsA in combination with basiliximab and steroids. It ended on August 24, 2011. Efficacy failure (biopsy-proven acute rejection, death, graft loss, or loss to follow-up), safety, and renal function were evaluated at 1, 3, 5, and 12 months post-transplantation.RESULTS:
Efficacy failure was comparable between the two groups. Only one graft loss has been reported in the control group and no patient death reported in either group. There was no significant difference in the incidence of biopsy-proven acute rejection until 3 and 5 month post-transplantation (P>0.05). The mean e-GFR of the group of EVE+reduced-dose CsA was significantly higher than that of the control group at 3 (65.6+/-16.9 mL/mim/1.73 m2 vs. 56.7+/-14.4 mL/mim/1.73 m2; P=0.007) and 5 (68.6+/-18.8 mL/mim/1.73 m2 vs. 58.1+/-16.2 mL/mim/1.73 m2; P=0.009) months. There was no significant difference in the incidence of discontinuations and serious adverse events between the groups (P>0.05).CONCLUSIONS:
The regimen of EVE+reduced-dose CsA seems to be tolerated well, with comparable efficacy failure and better renal function than enteric-coated mycophenolate sodium+standard-dose CsA.
Texto completo:
Disponível
Contexto em Saúde:
ODS3 - Meta 3.4 Reduzir as mortes prematuras devido doenças não transmissíveis
Problema de saúde:
Neoplasias do Rim, Pelve Renal e Ureteral
Base de dados:
WPRIM (Pacífico Ocidental)
Assunto principal:
Rejeição em Psicologia
/
Sódio
/
Esteroides
/
Proteínas Recombinantes de Fusão
/
Incidência
/
Terapia de Imunossupressão
/
Transplante de Rim
/
Ciclosporina
/
Transplantes
/
Sirolimo
Tipo de estudo:
Ensaio clínico controlado
/
Estudo de incidência
/
Estudo prognóstico
Limite:
Humanos
Idioma:
Coreano
Revista:
The Journal of the Korean Society for Transplantation
Ano de publicação:
2012
Tipo de documento:
Artigo