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PHARMACOKINETICS AND PHARMACODYNAMICS OF ORAL BUDESONIDE IN CHILDREN WITH CROHN'S DISEASE

ALBERER, M1; BUSCH, A2; ENNINGER, A3; BEHRENS, R4; KOLETZKO, S1; STERN, M2; GLEITER, C; DILGER, K6

Journal of Pediatric Gastroenterology and Nutrition: May 2006 - Volume 42 - Issue 5 - p E44
Notices: 39th Annual Meeting of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition Dresden, Germany, June 7-10, 2006: Abstracts: PG4-04
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1University children's hospital, Munich, Germany;

2University children's hospital, Tübingen, Germany;

3Olgahospital, Stuttgart, Germany;

4Children's hospital, Nürnberg, Germany;

5KKS-UKT gGmbH, Tübingen, Germany;

6Dr. Falk Pharma GmbH, Freiburg, Germany.

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Aim:

There is limited information on the use of oral budesonide in paediatric patients. The objective was to determine pharmacokinetics of budesonide in children with Crohn's disease.

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Methods:

We evaluated single and multiple dose pharmacokinetics of budesonide in 12 children with mild or moderate Crohn's disease (age range: 5-15 years,). Drug disposition and effects on endogenous cortisol (C) were evaluated by collecting blood and urine at intervals over 24 hours after first intake of 3 mg budesonide (single dose, day 1), and again after one week of thrice-daily dosing (day 8). Budesonide and two CYP3A-dependent metabolites (6β-OH-budesonide, 16α-OH-prednisolone) were measured by LC-MS/MS.

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Results:

Results are tabulated as mean (SD), (B = budesonide):

Table

Table

After one week of therapy, a reversible suppression of the adrenal gland was seen (morning cortisol in plasma 17 ± 13 μg/dl on day 1 vs. 9 ± 12 μg/dl, on day 8, p < 0.01). All children under 12 years of age (n = 3) had subnormal values. In all children plasma cortisol levels returned to normal 24 h after the last dosage.

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Conclusion:

Disposition of oral budesonide appears to be similar between children and adults, but the doctor has to be aware of an increased risk for adrenal suppression in paediatric patients.

© 2006 Lippincott Williams & Wilkins, Inc.