Reduced variability of Neoral pharmacokinetic studies in pediatric renal transplantation |
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Authors: | R J Portman H U Meier-Kriesche R Swinford P Brannan B D Kahan |
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Institution: | (1) Division of Pediatric Nephrology and Hypertension, University of Texas–Houston, Medical School, MSB 3.124, 6431 Fannin St, Houston, TX 77030, USA e-mail: ronald.portman@uth.tmc.edu Tel.: +1-713-500-5675, Fax: +1-713-500-5680, US;(2) Division of Nephrology and Hypertension, University of Texas–Houston, Medical School, Houston, Texas, USA, US;(3) Division of Pediatric Nephrology and Hypertension, University of Texas–Houston, Medical School and Hermann Children’s Hospital, Houston, Texas, USA, US;(4) Division of Pediatric Nephrology and Hypertension, Hermann Children’s Hospital, Houston, Texas, USA, US;(5) Division of Immunology and Organ Transplantation, University of Texas–Houston, Medical School, Houston, Texas, USA, US |
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Abstract: | In adult renal transplant recipients the Neoral area under the curve (AUC) displays less inter- and intra- individual variability
than Sandimmune, and those renal transplant recipients with reduced intra-individual variability of the AUC have a lower risk
for chronic rejection. As variability of Neoral pharmacokinetic (Pk) parameters has not been investigated in pediatric renal
transplant recipients, we retrospectively analyzed 453 Pk profiles in 14 pediatric patients who were switched from Sandimmune
to Neoral and compared the inter- and intra-individual variability of the Pk profiles on both formulations. After the switch,
we observed less inter- and intra-individual variability of AUC, the 2-h concentration, and the oral clearance. As clearance
with both formulations is supposedly equal, the significantly lower intra-individual variability of oral clearance is most
likely an effect of less variable absorption. While the lower inter-individual variability of the Pk parameters suggests increased
success in keeping cyclosporine concentrations on target, the lower intra-individual variability leads to the hypothesis that
with Neoral, a lower incidence of chronic rejection might be achieved.
Received: 8 February 2000 / Revised: 17 May 2000 / Accepted: 22 May 2000 |
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Keywords: | Neoral AUC Pharmacokinetics Renal transplantation Pediatrics |
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