A 21-week open-label clinical trial of pregabalin as adjunctive therapy in partial seizures at multiple centers in Mexico (PREPS Mexico).

Autor: Rivera-Castaño L; CIMA Centro Internacional de Medicina, Consultorio 16, Haciendas del Valle No 7120, Col Plaza Haciendas Chihuahua, Chihuahua 31238, Mexico. drleopoldo.rivera@yahoo.com, Leal-Cantu R, Abreu P, Guerrero M, Davila G
Jazyk: angličtina
Zdroj: Epilepsy research [Epilepsy Res] 2012 Jun; Vol. 100 (1-2), pp. 74-9. Date of Electronic Publication: 2012 Feb 02.
DOI: 10.1016/j.eplepsyres.2012.01.009
Abstrakt: Purpose: To investigate the efficacy of pregabalin in the treatment of refractory partial seizures.
Methods: This was a 21-week, open-label study of pregabalin (150-600 mg/day) as an adjunctive therapy in adults with refractory partial seizures. The study included an 8-week baseline period, a 9-week dose-optimization period, and a 12-week treatment-observation period. The primary assessment was mean percentage change in 28-day seizure rate between baseline and the last 12 weeks of treatment.
Results: In total, 136 Mexican patients were included in this study (55.9% women; mean age/epilepsy duration, 35.2/22.9 years). The median and mean (95% confidence interval [CI]) 28-day baseline seizure rates were 3.9 and 7.8 (5.4-10.2), respectively. The mean (95% CI) reduction in seizure frequency was 51.2% (43.0-59.3) over the last 12 weeks of treatment, while the median reduction was 57.9%. The percentage of patients with a ≥ 5 0% or ≥ 75% reduction in seizure frequency was 63.6% and 48.8%, respectively. The percentage of patients who were seizure-free during the last 4 and 12 weeks of treatment was 40.5% and 20.7%, respectively. The most common adverse events were somnolence (39.7%), dizziness (16.2%), and weight gain (14.0%).
Conclusion: Pregabalin was well tolerated and associated with significant reductions in seizure frequency.
(Copyright © 2012 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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