Tiagabine for Complex Partial Seizures
| Autor: | Vincent S. Shu, Basim M. Uthman, Steven C. Schachter, Kenneth W. Sommerville, Peter A. Ahmann, A. James Rowan, Ilo E. Leppik |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
Male Randomization Adolescent Tiagabine medicine.medical_treatment Nipecotic Acids Placebo Drug Administration Schedule Double-Blind Method Arts and Humanities (miscellaneous) medicine Humans Child Adverse effect Aged Valproic Acid Dose-Response Relationship Drug business.industry Middle Aged Treatment Outcome Anticonvulsant Tolerability Anesthesia Anticonvulsants Drug Therapy Combination Female Epilepsies Partial Neurology (clinical) business Reuptake inhibitor medicine.drug |
| Zdroj: | Archives of Neurology. 55:56 |
| ISSN: | 0003-9942 |
| DOI: | 10.1001/archneur.55.1.56 |
| Popis: | To determine the efficacy and tolerability of tiagabine, a new antiepileptic drug (AED) that inhibits gamma-aminobutyric acid (GABA) uptake, at 3 dose levels vs placebo as adjunctive therapy in patients with intractable complex partial seizures (CPS).Randomized, double-blind, placebo-controlled study with a parallel-group, add-on design, starting with a 12-week unblinded baseline phase followed by a 20-week double-blind treatment phase.Twenty-one US medical centers.Patients (N = 297) aged 12 to 77 years, previously diagnosed as having CPS and receiving stable regimens of 1 to 3 hepatic enzyme-inducing AEDs; divalproex sodium or valproic acid was allowed in combination with any of these drugs.Placebo or tiagabine 4 times a day at 16, 32, or 56 mg daily.Median change in 4-week CPS frequency and adverse events.Median decreases in 4-week CPS frequency for the 32-mg (-2.2) and 56-mg (-2.8) tiagabine groups were significantly greater than for the placebo (-0.7) group (P = .03 and P.03, respectively); 20% and 29% of patients in the 32- and 56-mg groups had a 50% or greater reduction in the frequency of CPS vs 4% in the placebo group (P = .002 and P.001, respectively). Adverse effects were similar for placebo and tiagabine except for a significantly greater incidence of dizziness in the 32-mg tiagabine group, tremor in the 32- and 56-mg groups, abnormal thinking (usually mental lethargy or difficulty concentrating) in the 56-mg group, and depressed mood in the 16- and 56-mg groups.Tiagabine is efficacious and well tolerated as adjunctive therapy for CPS; there is a clear dose-response relationship. |
| Databáze: | OpenAIRE |
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