TY - JOUR
T1 - Tiagabine in clinical practice
T2 - Effects on seizure control and behavior
AU - Vossler, David G.
AU - Morris, George L.
AU - Harden, Cynthia L.
AU - Montouris, Georgia
AU - Faught, Edward
AU - Kanner, Andres M.
AU - Fix, Aaron
AU - French, Jacqueline A.
N1 - Funding Information:
Multiple pharmaceutical companies provided unrestricted funds to the University of Pennsylvania to support the creation and maintenance of the PADS database. Abbott Laboratories, which in the past marketed tiagabine, was among these companies but had neither access to these data nor participated in any way in the preparation of this manuscript. Cephalon, Inc. currently markets Gabitril® in the United States, but did not fund the PADS database. The authors have no financial conflicts pertinent to this study. Dr. Vossler is on the speaker’s bureau of GlaxoSmithKline, Lundbeck and UCB Pharma and is a principal investigator for UCB Pharma, Vertex, Pfizer, and Sunovion Inc. Dr. Morris is on the speaker's bureau of UCB Pharma, Lundbeck and Cyberonics. Dr. Harden is a speaker for Glaxo SmithKline, UCB Pharma and Lundbeck and a consultant for Eisai and Upsher-Smith. Dr. Montouris is on the advisory boards of Eisai, Supernus, Lundbeck, and UCB Pharma. Dr. Faught has served as a consultant for Astellas, Eisai, GlaxoSmithKline, SK Life Science, Sunovion, and UCB Pharma, serves on Data Monitoring Boards for Eisai, Lundbeck, and SK Life Science, and receives research support from Brain Sentinel, The Epilepsy Consortium, NINDS via the University of Alabama at Birmingham, and UCB Pharma. Dr. Kanner has no disclosures. Dr. French has received grant funding from The Milken Foundation, the Epilepsy Therapy Project, and NINDS. She is President of The Epilepsy Study Consortium, a nonprofit organization that receives payments from multiple pharmaceutical companies. The Epilepsy Study Consortium pays a fixed amount of money for Dr. French's consulting and clinical trial work to New York University toward her faculty salary. She is an investigator on research trials sponsored by UCB, Pfizer, Lundbeck, Eisai, Upsher-Smith, Vertex, Impax, Mapp Pharmaceuticals, and Novartis.
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
KW - Adult
KW - Adverse event
KW - Behavior
KW - Children
KW - Efficacy
KW - Human
KW - Long-term
KW - Open-label
KW - Tiagabine
KW - Trial
UR - http://www.scopus.com/inward/record.url?scp=84879369445&partnerID=8YFLogxK
U2 - 10.1016/j.yebeh.2013.05.006
DO - 10.1016/j.yebeh.2013.05.006
M3 - Article
C2 - 23770680
AN - SCOPUS:84879369445
SN - 1525-5050
VL - 28
SP - 211
EP - 216
JO - Epilepsy and Behavior
JF - Epilepsy and Behavior
IS - 2
ER -