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Prediction of systemic exposure to cyclosporine in Japanese pediatric patients.

Authors
  • Sakaeda, Toshiyuki
  • Iijima, Kazumoto
  • Nozu, Kandai
  • Nakamura, Tsutomu
  • Moriya, Yuka
  • Nishikawa, Mika
  • Wada, Atsushi
  • Okamura, Noboru
  • Matsuo, Masafumi
  • Okumura, Katsuhiko
Type
Published Article
Journal
Journal of human genetics
Publication Date
Jan 01, 2006
Volume
51
Issue
11
Pages
969–976
Identifiers
PMID: 16972021
Source
Medline
License
Unknown

Abstract

The monitoring of the blood concentration at 2 h (C(2)) after the oral administration of a cyclosporine (CsA) microemulsion was reconfirmed to be useful for the prediction of systemic exposure, the area under the blood concentration-time curve from 0 to 4 h (AUC(0-4)), in a group of Japanese patients, consisting of 33 children aged 5-15 years and 19 young adults aged 16-27 years, with a greater correlation for C(2) (r = 0.927) than the trough concentration (r = 0.488). The dose-normalized AUC(0-4) was independent of gender or indications for CsA, while it depended on body size, i.e., the age (P = 0.065) and total body weight (P = 0.026). MDR1 C3435T had a weak, but insignificant effect (P = 0.072); it was about 22-31% lower in the patients with TT(3435). Co-administration of a steroid and further treatment with nifedipine had a more intensive effect (P = 0.018); co-administration resulted in a 51% increase in the dose-normalized AUC(0-4). A strong effect was also observed for the serum total cholesterol level (P = 0.001). Collectively, the discrepancies in the results on MDR1 C3435T among investigators might be due to variability in the age/total body weight, co-administration drugs or serum lipid level.

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