| Autor: |
Dunn, Stephen P., Cooney, Gerard F., Kulinsky, Anatoly, Falkenstein, Kathleen, Pierson, Andrea, Elder, Cheryl A., Meligeni, John |
| Zdroj: |
Transplantation; December 1995, Vol. 60 Issue: 12 p14381442-14381442, 1p |
| Abstrakt: |
In pediatric liver transplant recipients, oral cyclosporine CsA therapy may be complicated by impaired or delayed absorption during the initial weeks posttransplant. Neoral NL is a microemulsion preconcentrate formulation of CsA expected to increase the rate and extent of absorption of CsA and have less pharmacokinetic variability. The absolute bioavailability F of CsA from NL was compared with that of the currently marketed Sandimmune SM formulation in a doubleblind, crossover study conducted in 9 pediatric liver transplant recipients age 6 months to 11 years between 8 and 20 days posttransplant. After determination of CsA pharmacokinetics for a steadystate intravenous dose, patients were randomized to receive a single oral dose of NL or SM in period I and the alternative formulation in period II. Clearance Clt and volume of distribution Vss values mean±s.d. calculated from the i.v. dose were similar to that previously reported for pediatric patients Clt12.0±1.3 mlminkg Vss2.2±0.2 Lkg. Mean F ±SD for NL was significantly higher than SM NL37.6±14.6 SM24.7±8.0P0.05. Although not reaching statistical significance, the observed maximum blood concentration Cmax was higher, and the time to Cmax Tmax was shorter for NL in 8 of 9 patients. There were no significant correlations between age and any pharmacokinetic parameter for the group as a whole—however, there were statistically significant correlations between age and F for NL r0.87P0.02, and for age and Vss r0.91P0.01 for the 6 patients aged 2 years or less. In this pediatric liver transplant population, Neoral demonstrated improved absorption increase in F compared to Sandimmune. In liver transplant recipients aged 2 years or less, absorption of Neoral may be a function of age andor bowel length. |
| Databáze: |
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