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A multicenter survey of clinical experiences with perampanel in real life in Germany and Austria

机译:在德国和奥地利进行的关于perampanel在现实生活中的临床经验的多中心调查

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摘要

Perampanel (PER) has been approved by the European Medicines Agency (EMA) for adjunctive treatment of patients with partial-onset seizures from age 12 years on. It has been introduced to the market in Germany and Austria in 2012.This cross-sectional observational study summarizes the clinical experience of nine centers with adjunctive PER. Patients were consecutively followed from the initiation of PER on. Only patients with a minimum observational period of six months (in case of ongoing treatment) were recruited. Efficacy data reflect the preceding three months at last observation, tolerability data were assessed at the last observation carried forward.281 patients were included. After six months 169 were still on PER so that a retention rate of 60% resulted. 43 patients were seizure-free for the preceding 3 months (15%). Overall incidence of adverse events was 52.0%. The leading adverse events were somnolence (24.6%) and dizziness (19.6%) followed by ataxia (3.9%), aggression (2.8%), nausea (2.5%) and irritability (2.1%).We conclude that adjunctive PER may lead to at least temporary freedom of seizures in some of these highly difficult-to-treat patients. Adverse events are not uncommon.
机译:Perampanel(PER)已被欧洲药品管理局(EMA)批准用于12岁以上部分发作性癫痫的辅助治疗。它已于2012年在德国和奥地利上市。这项横断面观察研究总结了9个辅助性PER中心的临床经验。从开始PER开始连续随访患者。仅招募观察期最短为六个月的患者(如果正在进行治疗)。疗效数据反映了最近一次观察的前三个月,耐受性数据是在最后一次观察时进行的评估。其中包括281例患者。六个月后,仍有169人使用PER,因此保留率达到60%。前3个月无43例癫痫发作(15%)。不良事件的总发生率为52.0%。主要不良反应为嗜睡(24.6%)和头晕(19.6%),其次为共济失调(3.9%),攻击性(2.8%),恶心(2.5%)和烦躁(2.1%)。我们得出结论,辅助性PER可能导致在这些高度难治的患者中,至少有暂时的癫痫发作自由。不良事件并不少见。

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