Department of Neurology, University of Magdeburg, Magdeburg, Germany Neurological Clinic, University Hospital Erlangen, Erlangen, Germany.
Epilepsia. 2013 Jan;54(1):75-80. doi: 10.1111/j.1528-1167.2012.03651.x. Epub 2012 Sep 21.
This study investigates immediate efficacy and safety of intravenous application of de novo lacosamide (LCM) as add-on therapy in patients with pharmacoresistant focal epilepsy.
During presurgical video-electroencephalography (EEG) monitoring, 17 adult inpatients received LCM infusion (200 mg every 12 h for 2-3 days) followed by oral formulation with the same regimen. Before and after intravenous application of LCM, seizures and interictal epileptiform discharges (IEDs) recorded with continuous video-EEG monitoring were analyzed, and an assessment of adverse events (AEs) was performed daily. To evaluate the midterm tolerability and efficacy, follow-up visits were conducted 1 and 3 months after discharge from hospital.
In the acute phase, intravenous initiation of LCM was well tolerated with few mild or moderate AEs (3 of 17, 17.6%). A significant reduction of seizure frequency in the treatment phase as compared to mean seizure frequency in the 2-day baseline phase was achieved (p < 0.05 for the first treatment day, and p < 0.005 for the second treatment day). On the first treatment day, 61.5% of the patients were seizure free, and 84.6% on the second treatment day. IED reduction after intravenous application of LCM was not significant. After 1 month, the 50% responder rate was 46.6% and after the 3-month period, 42.8%.
Our data suggest that rapid intravenous initiation of de novo LCM is safe and may protect against seizures in a rapid and midterm time window.
本研究旨在调查静脉内应用新型拉考沙胺(LCM)作为耐药性局灶性癫痫附加治疗的即时疗效和安全性。
在术前视频脑电图(EEG)监测期间,17 名成年住院患者接受了 LCM 输注(每 12 小时 200mg,持续 2-3 天),随后以相同方案口服 LCM。在静脉内应用 LCM 前后,通过连续视频-EEG 监测分析记录的发作和发作间期癫痫样放电(IEDs),并每天评估不良反应(AE)。为了评估中期耐受性和疗效,在出院后 1 个月和 3 个月进行随访。
在急性期,静脉内起始 LCM 耐受性良好,仅有少数轻度或中度 AE(17 例中的 3 例,17.6%)。与 2 天基线期的平均发作频率相比,治疗期的发作频率显著降低(第一天治疗时 p < 0.05,第二天治疗时 p < 0.005)。第一天治疗时,61.5%的患者无发作,第二天治疗时 84.6%的患者无发作。静脉内应用 LCM 后 IED 减少不显著。治疗后 1 个月,50%反应率为 46.6%,3 个月时为 42.8%。
我们的数据表明,新型拉考沙胺的快速静脉起始是安全的,可能在快速和中期时间窗口内预防发作。