Ferrendelli J A, French J, Leppik I, Morrell M J, Herbeuval A, Han J, Magnus L
Department of Neurology, University of Texas-Houston School of Medicine, 6431 Fannin Street, Suite 7.044, 77030, Houston, TX, USA.
Epilepsy Behav. 2003 Dec;4(6):702-9. doi: 10.1016/j.yebeh.2003.09.007.
Levetiracetam (Keppra) was evaluated in a subset of patients aged >/=65 years (n=78) enrolled in a large (n=1030) open-label, phase IV trial (the KEEPER trial). A 4-week dose adjustment was followed by a 12-week evaluation period. An overall median reduction in partial seizures of 80.1% (n=65) was observed. Overall, 76.9% of patients were >/=50% responders, 56.9% were >/=75% responders, and 40.0% were 100% responders. Levetiracetam was well tolerated, with 42.3% of patients reporting one or more adverse events. A total of 15 patients (19.2%) experienced an adverse event that led to discontinuation. Somnolence (n=13,16.7%) and dizziness (n=7,9.0%) were the most commonly reported adverse events. Despite the limitations of the open-label study design, these data provide information regarding the use of levetiracetam as add-on therapy for the treatment of partial-onset seizures in patients >/=65 years of age, including those requiring concomitant medications.
左乙拉西坦（开浦兰）在一项大型（n = 1030）开放标签的IV期试验（KEEPER试验）中，对年龄≥65岁的亚组患者（n = 78）进行了评估。4周的剂量调整后是12周的评估期。观察到部分性癫痫发作总体中位数减少80.1%（n = 65）。总体而言，76.9%的患者缓解率≥50%，56.9%的患者缓解率≥75%，40.0%的患者缓解率达100%。左乙拉西坦耐受性良好，42.3%的患者报告了一种或多种不良事件。共有15名患者（19.2%）经历了导致停药的不良事件。嗜睡（n = 13，16.7%）和头晕（n = 7，9.0%）是最常报告的不良事件。尽管开放标签研究设计存在局限性，但这些数据提供了有关左乙拉西坦作为≥65岁患者部分性发作附加治疗药物使用的信息，包括那些需要联合用药的患者。
