title: Tiagabine in clinical practice: effects on seizure control and behavior.
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.
authors.affiliation: UW Medicine Valley Medical Center, University of Washington, Seattle, WA, USA. david_vossler@valleymed.org
authors.forename: David G
authors.initials: DG
authors.lastname: Vossler
authors.forename: George L
authors.initials: GL
authors.lastname: Morris
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Harden
authors.forename: Georgia
authors.initials: G
authors.lastname: Montouris
authors.forename: Edward
authors.initials: E
authors.lastname: Faught
authors.forename: Andres M
authors.initials: AM
authors.lastname: Kanner
authors.forename: Aaron
authors.initials: A
authors.lastname: Fix
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: French
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D001526:Behavioral Symptoms / Q000188:drug therapy* / Q000209:etiology*; D002648:Child; D002675:Child, Preschool; D004827:Epilepsy / Q000150:complications / Q000188:drug therapy / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D009557:Nipecotic Acids / Q000627:therapeutic use*; D000078308:Tiagabine; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D009557:Nipecotic Acids; D000078308:Tiagabine