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

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• 作者：Leopoldo Rivera-Casta&ntilde ; o^a ; ¹ ; ^{drleopoldo.rivera@yahoo.com} ; Raul Leal-Cantu^b ; ² ; ^{raull61@hotmail.com} ; Paula Abreu^c ; ³ ; ^{paula.abreu@pfizer.com} ; Marita Guerrero^d ; ⁴ ; ^{marita.guerrero@pfizer.com} ; Gabriela Davila^d ; ^{gabriela.davila@pfizer.com}
• 关键词：Pregabalin ; Partial seizures ; Open-label ; Adjunctive ; Efficacy ; Tolerability
• 刊名：Epilepsy Research
• 出版年：2012
• 出版时间：June, 2012
• 年：2012
• 卷：100
• 期：1-2
• 页码：74-79
• 全文大小：248 K

文摘

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Summary

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 ?0 % or ?5 % 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.