Wongjirattikarn Rachot, Sawanyawisuth Kittisak, Pranboon Sineenard, Tiamkao Siriporn, Tiamkao Somsak
Department of Medicine, Faculty of Medicine, and Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, 40002, Thailand.
Department of Medicine, Faculty of Medicine, and North-eastern Stroke Research Group, Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Research and Training Center for Enhancing Quality of Life of Working Age People, and Research and Diagnostic Center for Emerging Infectious Diseases (RCEID), Khon Kaen University, Khon Kaen, 40002, Thailand.
Neurol Ther. 2019 Dec;8(2):425-431. doi: 10.1007/s40120-019-00150-x. Epub 2019 Aug 12.
Intravenous levetiracetam (IV LEV) is approved for treatment status epilepticus (SE). However, the drug's high cost must be considered when deciding on a treatment strategy. This study aimed to compare the efficacy of brand-name and generic IV LEV for acute repetitive convulsive seizure (ARCS) or SE.
Forty patients aged 18 years or older who had been diagnosed with SE or ARCS were included in this double-blind study. Patients were randomly assigned at a 1:1 ratio (via computer-generated code) to receive either brand-name or generic IV LEV. The primary outcomes were seizure control and the number of seizure exacerbations during the 24 h after drug administration, while the secondary outcomes were electroencephalographic (EEG) findings, serious adverse events, and clinical outcome at hospital discharge.
Forty patients were randomly assigned administration with either brand-name IV LEV (10 SE and 10 ARCS patients) or generic IV LEV; 7 SE and 13 ARCS patients). There was no significant difference in patients' baseline characteristics. The seizure control rate was 75% in the brand-name IV LEV group and 65% in the generic IV LEV group (p value: 0.490). Five (25%) patients in the brand-name IV LEV group, and six (30%) patients in the generic IV LEV group developed seizure exacerbations within 24 h after drug administration (p value 0.723). There were no reports of drug-related adverse events. Two of the patients taking brand-name IV LEV and one taking the generic IV LEV died (p value > 0.999).
Treatment with the generic IV LEV had comparable outcomes with brand-name IV LEV. The generic IV LEV may be an alternative medication for the treatment of SE and ARCS to reduce treatment costs.
TCTR20190513001.
Great Eastern Drug Company.
静脉注射左乙拉西坦（IV LEV）已被批准用于治疗癫痫持续状态（SE）。然而，在制定治疗策略时必须考虑该药物的高成本。本研究旨在比较品牌名和通用型IV LEV治疗急性重复性惊厥发作（ARCS）或SE的疗效。
本双盲研究纳入了40名18岁及以上被诊断为SE或ARCS的患者。患者以1:1的比例（通过计算机生成的代码）随机分配接受品牌名或通用型IV LEV。主要结局是给药后24小时内的癫痫控制情况和癫痫发作加重次数，次要结局是脑电图（EEG）结果、严重不良事件和出院时的临床结局。
40名患者被随机分配接受品牌名IV LEV（10名SE患者和10名ARCS患者）或通用型IV LEV（7名SE患者和13名ARCS患者）治疗。患者的基线特征无显著差异。品牌名IV LEV组的癫痫控制率为75%，通用型IV LEV组为65%（p值：0.490）。品牌名IV LEV组有5名（25%）患者，通用型IV LEV组有6名（30%）患者在给药后24小时内出现癫痫发作加重（p值0.723）。没有药物相关不良事件的报告。服用品牌名IV LEV的2名患者和服用通用型IV LEV的1名患者死亡（p值>0.999）。
通用型IV LEV治疗的结局与品牌名IV LEV相当。通用型IV LEV可能是治疗SE和ARCS的替代药物，以降低治疗成本。
TCTR20190513001。
大东方制药公司。
