Epilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe University, Frankfurt am Main, Germany.
Epilepsy Center Hessen and Department of Neurology, Philipps University, Marburg, Germany.
Epilepsia. 2018 Aug;59(8):1549-1556. doi: 10.1111/epi.14476. Epub 2018 Jun 25.
The objective of this study was to evaluate effectiveness, retention, and tolerability of brivaracetam (BRV) in genetic generalized epilepsies (GGE) in clinical practice.
A multicenter, retrospective cohort study recruiting all patients that started BRV in 2016 and 2017.
A total of 61 patients (mean age = 29.8, range = 9-90 years, 41 female [67%]) were treated with BRV. They were difficult to control, with 2.4 failed antiepileptic drugs (AEDs) in the past, taking 1.9 AEDs on average at baseline. The length of exposure to BRV ranged from 7 days to 24 months, with a mean retention time of 7.9 months, resulting in a total exposure time to BRV of 483 months. The retention rate was 82% at 3 months and 69% at 6 months. Efficacy at 3 months was 36% (50% responder rate), with 25% seizure-free for 3 months. Patients with juvenile myoclonic epilepsy showed a responder rate of 60%, with 40% being free of any seizures. Long-term 50% responder rate was present in 17 patients (28%; 11 seizure-free [18%]) for >6 months and in 14 patients (23%; 10 seizure-free [16%]) for >12 months. Treatment-emergent adverse events were observed in 26% of the patients, with the most common being somnolence, ataxia, and psychobehavioral adverse events. Use of intravenous BRV with bolus injection of 200-300 mg in two females with absence status epilepticus was well tolerated, but did not result in cessation of status epilepticus.
Use of BRV in GGE is well tolerated, and 50% responder rates are similar to those observed in the regulatory trials for focal epilepsies. An immediate switch from levetiracetam (LEV) to BRV at a ratio of 15:1 is feasible. The occurrence of psychobehavioral adverse events seems less prominent than under LEV, and a switch to BRV can be considered in patients with LEV-induced adverse events.
本研究旨在评估布里瓦卡坦（BRV）在临床实践中治疗遗传性全面性癫痫（GGE）的疗效、保留率和耐受性。
这是一项多中心、回顾性队列研究，招募了所有 2016 年和 2017 年开始使用 BRV 的患者。
共纳入 61 例患者（平均年龄 29.8 岁，范围 9-90 岁，41 例女性[67%]），接受 BRV 治疗。他们的癫痫发作难以控制，过去有 2.4 种失败的抗癫痫药物（AEDs），基线时平均服用 1.9 种 AED。BRV 的暴露时间从 7 天到 24 个月不等，平均保留时间为 7.9 个月，BRV 的总暴露时间为 483 个月。3 个月时的保留率为 82%，6 个月时为 69%。3 个月时的疗效为 36%（50%应答率），25%患者 3 个月无癫痫发作。青少年肌阵挛性癫痫患者的应答率为 60%，40%患者无任何癫痫发作。17 例患者（28%）>6 个月和 14 例患者（23%）>12 个月的长期 50%应答率为 17 例（11 例无癫痫发作[18%]）和 14 例（10 例无癫痫发作[16%]）。26%的患者出现治疗相关不良事件，最常见的是嗜睡、共济失调和精神行为不良事件。两名癫痫持续状态女性患者静脉注射 BRV 推注 200-300mg 治疗，耐受性良好，但未能终止癫痫持续状态。
BRV 在 GGE 中的应用具有良好的耐受性，50%应答率与局灶性癫痫监管试验中的观察结果相似。立即将左乙拉西坦（LEV）转换为 BRV，比例为 15:1 是可行的。与 LEV 相比，精神行为不良事件的发生率似乎较低，对于 LEV 引起的不良事件，可以考虑转换为 BRV。
