Document Detail


A single-dose study to define tiagabine pharmacokinetics in pediatric patients with complex partial seizures.
MedLine Citation:
PMID:  9109895     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
We report an open-label study of 25 children with complex partial seizures that assessed the pharmacokinetics and safety of a single dose of approximately 0.1 mg/kg tiagabine. The children received their usual individualized regimen of one concomitant antiepilepsy drug (AED) throughout the study. Seventeen children were receiving an inducing AED (carbamazepine or phenytoin); eight were receiving valproate. Tiagabine was well tolerated. Dose-normalized Cmax was higher in children taking valproate (18.2 +/- 5.0 ng/mL/mg) than in the induced children (14.8 +/- 6.9 ng/mL/mg), but the difference was not statistically significant. Dose-normalized area under the plasma concentration-time curve from time zero to infinite time was significantly higher (p = 0.002) in children taking valproate (176.5 +/- 54.7 ng.hr/mL/mg) than in induced children (92.4 +/- 56.7 ng.hr/mL/mg). Similarly, oral clearance in the children taking valproate (96 +/- 39 mL/min) was half that of the induced children (207 +/- 91 mL/min). Half-life in children taking valproate (5.7 hr) was almost twice that for the induced children (3.2 hr), and the elimination rate constant was significantly lower (p < 0.02) for the children taking valproate than for the induced children. Volume of distribution was similar in the children taking valproate (52 +/- 9 L) and the induced children (59 +/- 29 L). This is consistent with observations in adults taking tiagabine with inducing AEDs or valproate. Exploratory regressions on these data in children and previous data in adults showed fairly strong relationships between body size and tiagabine clearance and volume of distribution, with body size explaining about 40 to 50% of the variability. When adjusted per kg body weight, clearance and volume were greater in children than adults. When adjusted per m2 body surface area, clearance and volume were more similar in adults and children.
Authors:
L E Gustavson; S W Boellner; G R Granneman; J X Qian; H J Guenther; T el-Shourbagy; K W Sommerville
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Neurology     Volume:  48     ISSN:  0028-3878     ISO Abbreviation:  Neurology     Publication Date:  1997 Apr 
Date Detail:
Created Date:  1997-05-15     Completed Date:  1997-05-15     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1032-7     Citation Subset:  AIM; IM    
Affiliation:
Pharmaceutical Products Division, Abbott Laboratories, Abbott Park, IL 60064-3500, USA.
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MeSH Terms
Descriptor/Qualifier:
Anticonvulsants / administration & dosage,  pharmacokinetics*,  therapeutic use
Body Constitution
Child
Child, Preschool
Drug Therapy, Combination
Epilepsy, Complex Partial / drug therapy,  metabolism*
Female
Humans
Male
Nipecotic Acids / administration & dosage,  pharmacokinetics*,  therapeutic use
Sleep Stages
Valproic Acid / therapeutic use
Chemical
Reg. No./Substance:
0/Anticonvulsants; 0/Nipecotic Acids; 115103-54-3/tiagabine; 99-66-1/Valproic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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