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| Content Provider | Springer Nature Link |
|---|---|
| Author | Bouazza, Naïm Djerada, Zoubir Gozalo, Claire Busiah, Kanetee Beltrand, Jacques Berdugo, Marianne Urien, Saik Treluyer, Jean Marc Polak, Michel |
| Copyright Year | 2016 |
| Abstract | Glibenclamide (Gb) is used in type II diabetes mellitus but also in the last 10 years, off label, in patients with neonatal syndromic hyperglycemia carrying a mutation of Kir6.2 or SUR1. No studies have reported Gb pharmacokinetics in children. In this study, oral Gb pharmacokinetics was investigated in children in order to describe the concentration time courses, the influence of covariates, and the relationships between drug concentrations and efficacy.Gb concentrations were measured in 18 children after the switch from subcutaneous insulin to oral tablets of Gb (crushed tablets for 33 % of patients). A total of 229 plasma Gb concentrations and 187 blood glucose measurements were available. A population model was developed with NONMEM.Body weight was the most significant parameter on clearance and explained a substantial part of the variability. A variant genotype of CYP2C9 (i.e., *1/*2 and *1/*3) explained also a part of the remaining variability on Gb clearance. Patients carrying these allelic variants had a clearance decreased by 45 %. A link between daily area under the curve (AUC0–24 h) and metabolic control diabetes was found.This study evaluates for the first time the pharmacokinetics of oral Gb in children and constitutes a first step towards dose individualization of this drug in a particularly vulnerable population. |
| Starting Page | 1373 |
| Ending Page | 1379 |
| Page Count | 7 |
| File Format | |
| ISSN | 00316970 |
| Journal | European Journal of Clinical Pharmacology |
| Volume Number | 72 |
| Issue Number | 11 |
| e-ISSN | 14321041 |
| Language | English |
| Publisher | Springer Berlin Heidelberg |
| Publisher Date | 2016-08-25 |
| Publisher Place | Berlin, Heidelberg |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Population pharmacokinetics Diabetes mellitus Glibenclamide Children Neonatal diabetes mellitus Neonatal syndromic hyperglycemia Pharmacology/Toxicology |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology Pharmacology (medical) |
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