An open-label, add-on study of pregabalin in patients with partial seizures: A multicenter trial in Greece |
| |
Authors: | Stefanos Tsounis Vasilios K. Kimiskidis Dimitrios Kazis Konstantinos Gkiatas Kyriakos Garganis Klimentini Karageorgiou Stylianos Giannakodimos Panagiotis Papathanasopoulos Andreas Plaitakis Alexandros Papadimitriou Leonidas Lyras Birol Emir |
| |
Affiliation: | aB’Department of Neurology, Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki, Greece;bC’Department of Neurology, Aristotle University of Thessaloniki, G. Papanikolaou Hospital, GR-57 010 Thessaloniki, Greece;c251 Airforce General Hospital, Athens, Greece;dNeurological Department, Clinic “Ag Loukas,” Thessaloniki, Greece;eNeurology Unit, General State Hospital of Athens, Athens, Greece;fDepartment of Neurology, Medical School of Patras, Patras, Greece;gDepartment of Neurology, University of Crete Medical School, Heraklion, Greece;hDepartment of Neurology, University of Thessaly, Larissa, Greece;iPfizer Hellas, Athens, Greece;jPfizer Global Pharmaceuticals, New York, NY, USA |
| |
Abstract: | IntroductionPregabalin efficacy and safety as an adjunctive treatment for partial seizures was evaluated using an open-label, flexible-dose.Study designIn 98 adults with refractory partial epilepsy taking 1–3 anti-epileptic drugs with ≥2 seizures during an 8-week baseline period.MethodsPregabalin 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.ResultsPregabalin 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%).ConclusionsThe 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. |
| |
Keywords: | Partial seizures Refractory seizures Pregabalin Anxiety Adjunctive treatment |
本文献已被 ScienceDirect 等数据库收录! |
|