Population pharmacokinetic and exposure-response analyses of guanfacine in Japanese pediatric ADHD patients
| Autor: | Toshihiro Wajima, Yumiko Matsuo, Yoshiyuki Tsuda, Sayaka Matsumoto |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Adolescent Population Pharmaceutical Science behavioral disciplines and activities 030226 pharmacology & pharmacy Placebo group 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Rating scale mental disorders Humans Medicine Pharmacology (medical) Guanfacine Hydrochloride Child education Exposure response 030304 developmental biology Pharmacology Volume of distribution 0303 health sciences education.field_of_study business.industry Guanfacine Attention Deficit Disorder with Hyperactivity Female business medicine.drug |
| Zdroj: | Drug Metabolism and Pharmacokinetics. 34:365-371 |
| ISSN: | 1347-4367 |
| Popis: | Guanfacine hydrochloride extended-release tablet (GXR) is approved for child and adolescent patients with attention-deficit/hyperactivity disorder (ADHD). The aims of this study were to develop a population pharmacokinetic model of guanfacine after administration of GXR and to evaluate factors influencing the pharmacokinetics of guanfacine in pediatric ADHD patients. A population pharmacokinetic analysis was performed using 3231 plasma concentration data items of guanfacine for pediatric ADHD patients aged 6-17 years obtained from clinical studies in Japan and the US. In addition, the relationship of the ADHD Rating Scale IV (ADHD RS-IV, efficacy endpoint) total score with exposure to guanfacine was assessed for Japanese pediatric ADHD patients. A one-compartment model with first-order absorption and lag time well described the plasma concentration data of guanfacine in pediatric ADHD patients. Body weight was selected as a covariate of apparent total body clearance and apparent volume of distribution. There was no pharmacokinetic difference between Japanese and non-Japanese pediatric ADHD patients. The results suggested a tendency of exposure-dependent reduction in the ADHD RS-IV total score, whereas the reduction was observed even at low plasma exposure levels compared with the placebo group. |
| Databáze: | OpenAIRE |
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