An open-label, add-on study of pregabalin in patients with partial seizures: a multicenter trial in Greece.
Τίτλος | An open-label, add-on study of pregabalin in patients with partial seizures: a multicenter trial in Greece. |
Publication Type | Journal Article |
Year of Publication | 2011 |
Authors | Tsounis, S., Kimiskidis V. K., Kazis D., Gkiatas K., Garganis K., Karageorgiou K., Giannakodimos S., Papathanasopoulos P., Plaitakis A., Papadimitriou A., Lyras L., & Emir B. |
Journal | Seizure |
Volume | 20 |
Issue | 9 |
Pagination | 701-5 |
Date Published | 2011 Nov |
ISSN | 1532-2688 |
Λέξεις κλειδιά | Adjuvants, Pharmaceutic, Adolescent, Adult, Drug Administration Schedule, Epilepsies, Partial, Female, gamma-Aminobutyric Acid, Greece, Humans, Male, Middle Aged, Treatment Outcome, Young Adult |
Abstract | INTRODUCTION: Pregabalin efficacy and safety as an adjunctive treatment for partial seizures was evaluated using an open-label, flexible-dose.STUDY DESIGN: In 98 adults with refractory partial epilepsy taking 1-3 anti-epileptic drugs with ≥2 seizures during an 8-week baseline period.METHODS: Pregabalin was increased to ≤600 mg/day during a 9-week dose optimization period with dosage maintained for 12 additional weeks. Primary endpoint was the percentage change in partial seizure frequency between the 8-week baseline and 12-week observation period.RESULTS: Pregabalin treatment was associated with a significant reduction in partial seizure frequency: median percent change in partial seizure frequency from baseline to 12 weeks was -33% and -22% in patients with a baseline seizure frequency of ≤3 and >3 per 28 days, respectively. The 50% and 75% responder rates were 41.94% (95% CI: 31.91-51.96) and 30.11% (95% CI: 20.78-39.43), respectively. Nineteen percent of subjects were seizure-free throughout the last 12 weeks. Pregabalin administration resulted in a significant reduction in anxiety (mean reduction in Hospital Anxiety and Depression Scale scores of 1.68 units, 95% CI: -2.60 to -0.76). Most patients were much improved or very much improved on Patient Global Impression of Change (53.8%) and Clinical Global Impression of Change (53.8%). The most frequently self-reported adverse events (AEs) were mild or moderate somnolence (20.4%) and dizziness (5.1%) with a low AE discontinuation rate (5.1%).CONCLUSIONS: The efficacy and side-effect profile of pregabalin were similar to previous pregabalin double-blind, controlled studies. Additionally, pregabalin, as an add-on treatment for partial epilepsy, exhibits significant anti-anxiety properties. |
DOI | 10.1016/j.seizure.2011.06.022 |
Alternate Journal | Seizure |
PubMed ID | 21775167 |