Tiagabine in clinical practice: Effects on seizure control and behavior

David G. Vossler, George L. Morris, Cynthia L. Harden, Georgia Montouris, Edward Faught, Andres M. Kanner, Aaron Fix, Jacqueline A. French

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

Objective: Preapproval randomized controlled trials of antiepileptic drugs provide data in limited patient groups. We assessed the side effect and seizure reduction profile of tiagabine (TGB) in typical clinical practice. Methods: Investigators recorded adverse effect (AE), seizure, and assessment-of-benefit data prospectively in sequential patients treated open label with TGB. Results: Two hundred ninety-two patients (39 children) were enrolled to be treated long term with TGB. Seizure types were focal-onset (86%), generalized-onset (12%), both focal- and generalized-onset (0.3%), and multiple associated with Lennox-Gastaut Syndrome (2%). Two hundred thirty-one received at least one dose of TGB (median = 28. mg/day) and had follow-up seizure or AE data reported. Common AEs were fatigue, dizziness, psychomotor slowing, ataxia, gastrointestinal upset, weight change, insomnia, and "others" (mostly behavioral). Serious AEs occurred in 19 patients: behavioral effects (n= 12), status epilepticus (n= 3), others (n = 3), and sudden unexplained death (n= 1). No patients experienced suicidal ideation/behavior, rash, nephrolithiasis, or organ failure. Seizure outcomes were seizure freedom (5%), ≥. 75% reduction (12%), ≥. 50% reduction (23%), and increased number of seizures (17%), or new seizure type (1%). Conclusions: Behavioral AEs occurred in a larger proportion of patients compared to those reported in TGB preapproval randomized controlled trials. A moderate percentage of patients had a meaningful reduction in seizure frequency. In clinical practice, TGB remains a useful antiepileptic drug.

Original languageEnglish (US)
Pages (from-to)211-216
Number of pages6
JournalEpilepsy and Behavior
Volume28
Issue number2
DOIs
StatePublished - Jan 1 2013

Keywords

  • Adult
  • Adverse event
  • Behavior
  • Children
  • Efficacy
  • Human
  • Long-term
  • Open-label
  • Tiagabine
  • Trial

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Behavioral Neuroscience

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  • Cite this

    Vossler, D. G., Morris, G. L., Harden, C. L., Montouris, G., Faught, E., Kanner, A. M., Fix, A., & French, J. A. (2013). Tiagabine in clinical practice: Effects on seizure control and behavior. Epilepsy and Behavior, 28(2), 211-216. https://doi.org/10.1016/j.yebeh.2013.05.006