Neoral pharmacokinetics in Latino and Caucasian pediatric renal transplant recipients

Pediatr Nephrol (2001) 16:311–314

© IPNA 2001

T R A N S P L A N TAT I O N / O R I G I N A L A R T I C L E

Jacques Lemire · Edmund V. Capparelli Nadine Benador · Paul Grimm · Dina Macdonald Vivian Reznik

Neoral pharmacokinetics in Latino and Caucasian pediatric renal transplant recipients Received: 30 June 2000 / Revised: 21 November 2000 / Accepted: 21 November 2000

Abstract Interpopulation variability of drug pharmacokinetics (PK) has been described. For example, the systemic clearance of nifedipine is higher in Mexicans than Caucasians. African-Americans have a lower cyclosporine bioavailability than Caucasians. Limited data are available in the Latino population. Under identical conditions, we compared the PK profile of Neoral (cyclosporine for microemulsion) obtained in stable pediatric renal transplant recipients of Latino and Caucasian origin. A slightly lower area under the curve (AUC) when corrected for dose per body surface area or per kilogram of body weight was observed in Caucasians compared with Latinos. This difference was more pronounced in the younger age group (0.20 P>0.20 P=0.05 P>0.20 P>0.20 P>0.20 P>0.20 P>0.20 P>0.20 P>0.20

The overall pharmacokinetic profile of Neoral in Latinos and Caucasians is shown in Fig. 1. A higher absorption of the drug was observed in Latinos. Table 1 depicts the specific pharmacokinetic parameters of Neoral in the two groups, and includes the effect of age on the results. The slightly increased AUC in Latinos results from a higher AUC in the children less than 12 years of age, but this difference did not reach significance. Similar Cmax, tmax, P/T ratio, and C0 were observed.

Table 2 Apparent clearance of Neoral, dose adjusted to body surface area, and AUC related to dose in Latinos and Caucasians

Fig. 1 Pharmacokinetic profile of cyclosporine for microemulsion (Neoral) in Latino (n=14) and Caucasian (n=14) stable pediatric renal transplant recipients (±SEM). Values are adjusted for milligrams per kilogram of cyclosporine dose

Fig. 2 Apparent clearance (CL/F) of cyclosporine for microemulsion (Neoral) in Latinos (●) and Caucasians (▲) in the younger age group (