title: Tiagabine: absence of kinetic or dynamic interactions with ethanol.
abstract: Tiagabine is a new antiepileptic drug that inhibits the uptake of gamma-aminobutyric acid into neurons and glia. This double-blind, placebo-controlled study investigated the effect of multiple doses of tiagabine on the adverse cognitive effects produced by a single dose of ethanol in 20 healthy volunteers. The effects of each drug on the pharmaco-kinetics of the other were also determined. Compared with placebo, tiagabine produced no statistically significant effects on digit vigilance speed (primary assessment variable) or accuracy, choice reaction time, immediate or delayed word recall, delayed word recognition speed or sensitivity, visual tracking, body sway, or subjective measures of alertness, calmness, and contentment. There was no evidence of a pharmacodynamic interaction between tiagabine and ethanol with respect to these variables. The pharmacokinetic parameters of tiagabine and ethanol (maximum plasma concentration [Cmax], time to Cmax and area under the plasma concentration-time curve) were unchanged during concomitant administration. Adverse events, which mainly affected the central nervous system, occurred with a similar incidence during tiagabine and placebo administration and were more common after the administration of ethanol. There appears to be no need for additional caution regarding driving or operating machinery when ethanol is administered to patients taking tiagabine.
authors.affiliation: Clinical Development, Novo Nordisk A/S, Bagsvaerd, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Kastberg
authors.forename: J A
authors.initials: JA
authors.lastname: Jansen
authors.forename: G
authors.initials: G
authors.lastname: Cole
authors.forename: K
authors.initials: K
authors.lastname: Wesnes
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000494:pharmacology*; D003071:Cognition / Q000187:drug effects*; D018592:Cross-Over Studies; D003936:Diagnosis, Computer-Assisted; D004311:Double-Blind Method; D004347:Drug Interactions; D000431:Ethanol / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D014179:Neurotransmitter Uptake Inhibitors / Q000494:pharmacology*; D009557:Nipecotic Acids / Q000494:pharmacology*; D011594:Psychometrics / Q000379:methods; D000078308:Tiagabine
chemical_list: D000927:Anticonvulsants; D014179:Neurotransmitter Uptake Inhibitors; D009557:Nipecotic Acids; D000431:Ethanol; D000078308:Tiagabine