 |
|
Tiagabine Therapy for Complex Partial SeizuresA Dose-Frequency Study
Rajesh C. Sachdeo, MD;
Robert F. Leroy, MD;
Gregory L. Krauss, MD;
Miles E. Drake, Jr, MD;
Philip M. Green, MD;
Ilo E. Leppik, MD;
Vincent S. Shu, PhD;
Gary L. Ringham, PhD;
Kenneth W. Sommerville, MD;
Tiagabine Study Group
Arch Neurol. 1997;54(5):595-601.
Abstract
| |
Objective
To evaluate the efficacy and safety of 2 regimens of tiagabine as add-on therapy for patients with complex partial seizures (CPSs) that are refractory to other treatment.
Design
Randomized, double-blind, placebocontrolled, add-on, parallel-group trial with an 8-week baseline period, 12-week experimental period (4 weeks of dose titration and 8 weeks of fixed-dose therapy), and 4-week termination period.
Setting
Twenty-six centers throughout the United States.
Patients
Three hundred fifty-one patients were enrolled, 318 were entered in the double-blind period, and 271 completed the study.
Interventions
Tiagabine, 16 mg 2 times per day (106 patients); tiagabine, 8 mg 4 times daily (105 patients); and placebo (107 patients). The doses of tiagabine were titrated in 3 steps to the fixed dose.
Main Outcome Measure
The median change in the 4-week rate of CPSs from baseline to experimental period.
Results
The median change from baseline was –1.6 CPSs per 4 weeks in the group of patients who were given tiagabine 2 times per day, and it was –1.2 CPSs in the group of patients who were given tiagabine 4 times per day (P=.06 and P=.02, respectively, compared with placebo). The 4-week seizure frequency was reduced by 50% or more in 31% of the patients who were given tiagabine 2 times per day and in 27% of the patients who were given tiagabine 4 times per day vs 10% of the placebo-treated patients (P .001 for each tiagabine-treated group compared with the placebo group). The most frequent adverse events involved the central nervous system and occurred in comparable proportions in the 3 treatment groups. Similar proportions of patients discontinued the study prematurely for adverse events.
Conclusions
Tiagabine administered 2 and 4 times daily as add-on pharmacotherapy was effective in reducing CPSs in patients with epilepsy whose conditions were refractory to treatment with other antiepileptic agents, and it was well tolerated.
Author Affiliations
From the Department of Neurology, University of Medicine and Dentistry of New Jersey, New Brunswick (Dr Sachdeo); the Neurological Clinic of Texas, Dallas (Dr Leroy); Department of Neurology, The Johns Hopkins Hospital, Baltimore, Md (Dr Krauss); Department of Neurology, the Ohio State University Medical Center, Columbus (Dr Drake); the Kalamazoo Neurology PC, Kalamazoo, Mich (Dr Green); the MINCEP Epilepsy Care, Minneapolis, Minn (Dr Leppik); and Neurotherapeutics Venture and Department of Statistics, Abbott Laboratories, North Chicago, Ill (Drs Shu, Ringham, and Sommerville).
Footnotes
Accepted for publication November 20, 1996.
This study was supported by a grant from Abbott Laboratories, North Chicago, Ill.
The study medication in blister cards was supplied by Abbott Laboratories.
Reprints: Rajesh C. Sachdeo, MD, University of Medicine and Dentistry of New Jersey, 97 Paterson St, New Brunswick, NJ 08901-2160.
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati  Twitter
What's this?
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Assessing the Cost-Effectiveness of New Pharmaceuticals in Epilepsy in Adults: The Results of a Probabilistic Decision Model
Hawkins et al.
Med Decis Making 2005;25:493-510.
ABSTRACT
Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy
Beydoun et al.
Neurology 2005;64:475-480.
ABSTRACT
| FULL TEXT
Efficacy and tolerability of the new antiepileptic drugs II: Treatment of refractory epilepsy: Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society
French et al.
Neurology 2004;62:1261-1273.
ABSTRACT
| FULL TEXT
The New Antiepileptic Drugs: Scientific Review
LaRoche and Helmers
JAMA 2004;291:605-614.
ABSTRACT
| FULL TEXT
Antiepileptic Drug Therapy for Adults: When to Initiate and How to Choose
Sirven
Mayo Clin Proc. 2002;77:1367-1375.
ABSTRACT
Aggravation of partial seizures by antiepileptic drugs: Is there evidence from clinical trials?
Somerville
Neurology 2002;59:79-83.
ABSTRACT
| FULL TEXT
Integrating clinical trial data into clinical practice
Glauser
Neurology 2002;58:S6-S12.
FULL TEXT
New Antiepileptic Drugs: Into the New Millennium
Tatum et al.
Arch Fam Med 2000;9:1135-1141.
ABSTRACT
| FULL TEXT
{blacktriangledown}Tiagabine: add-on treatment for partial seizures
DTB 2000;38:47-48.
ABSTRACT
| FULL TEXT
Managing Pediatric Epilepsy Syndromes With New Antiepileptic Drugs
Pellock
Pediatrics 1999;104:1106-1116.
ABSTRACT
| FULL TEXT
|
