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Pharmacokinetic variability of sirolimus in Taiwanese renal transplant recipients.
Chueh, S-C J; Wang, S-M; Lai, M-K; Chen, J.
Afiliación
  • Chueh SC; Department of Urology, National Taiwan University Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. scchueh@ha.mc.ntu.edu.tw
Transplant Proc ; 36(7): 2058-9, 2004 Sep.
Article en En | MEDLINE | ID: mdl-15518745
To evaluate the pharmacokinetic variability of sirolimus (Rapamycin, SRL) in our renal transplant (RTx) recipients, dose-normalized trough concentration (C(0)) of SRL, and their intrasubject coefficients of variation (%CV) were analyzed. Thirty-eight patients were enrolled in regimens containing SRL. Concomitant immunosuppression included steroids (n = 38), cyclosporine (n = 33), tacrolimus (n = 3), and mycophenolate mofetil (n = 7). The mean dose-normalized C(0) was 2.13 +/- 0.91 ng/mL/mg. The intrasubject %CV of the dose-normalized C(0) ranged from 14% to 88% and averaged 42% in our series. The mean dose-normalized C(0) of SRL in our RTx recipients was much lower than that reported in Phase III trials. The intrasubject variation of dose-normalized C(0), even after administrating SRL for 6 months, could still be quite prominent. Thus, we suggest that, to maintain adequate therapeutic concentrations, periodic (monthly or bimonthly) SRL C(0) measurement is necessary in Taiwanese (Oriental) patients receiving SRL.
Asunto(s)
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante de Riñón / Sirolimus Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Transplant Proc Año: 2004 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Estados Unidos
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante de Riñón / Sirolimus Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Transplant Proc Año: 2004 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Estados Unidos