在亚洲癫痫患者中进行的吡仑帕奈长期安全性和疗效的事后分析。
A post hoc analysis of the long-term safety and efficacy of perampanel in Asian patients with epilepsy.
机构信息
National Epilepsy Center, NHO Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Japan.
North Tohoku Epilepsy Center, Minato Hospital, Hachinohe, Japan.
出版信息
Epilepsia. 2019 Mar;60 Suppl 1:60-67. doi: 10.1111/epi.14645.
This post hoc analysis assessed the long-term safety, tolerability, and efficacy of perampanel in Asian patients with refractory focal seizures; an additional analysis assessed the effect of perampanel on focal impaired awareness seizures (FIAS) with focal to bilateral tonic-clonic (FBTC) seizures. In this subanalysis, data from Asian patients ≥12 years of age who had focal seizures with FBTC seizures despite taking one to 3 concomitant antiepileptic drugs at baseline, and who had entered either the long-term extension phase of 3 phase-3 perampanel trials (study 307) or the 10-week extension phase of study 335, were analyzed for the effect of perampanel on duration of exposure, safety, and seizure outcomes. Of 874 Asian patients included in the analysis, 205 had previously received placebo during the double-blind phase-3 trials and 669 had previously received perampanel 2-12 mg/day; 313 had FIAS with FBTC seizures at core study baseline. The median duration of exposure to perampanel was 385.0 days, and the retention rate at one year was 62.6%. Overall, during the first 52 weeks of perampanel treatment, 777 patients (88.9%) had treatment-emergent adverse events (TEAEs), most of which were mild to moderate in severity. The most frequent TEAEs were dizziness (47.1%), somnolence (22.3%), and nasopharyngitis (17.4%). During the first 52 weeks of perampanel treatment, median percent change in seizure frequency per 28 days from pre-perampanel baseline for all focal seizures was -28.1%, and -51.7% for FIAS with FBTC seizures. The 50% responder rate relative to pre-perampanel baseline for all focal seizures was 33.8%, and 51.1% for FIAS with FBTC seizures. Long-term treatment with perampanel in Asian patients had safety, tolerability, and efficacy similar to that of the global population in the phase-3 trials and extension study 307. The safety profile and response rate suggest benefit for an Asian population of patients with refractory epilepsy.
本事后分析评估了普瑞巴林在亚洲难治性局灶性癫痫患者中的长期安全性、耐受性和疗效；另一项分析评估了普瑞巴林对伴有局灶性全面性意识障碍发作（FIAS）的局灶性强直-阵挛发作（FBTC）发作的影响。在这项亚分析中，对基线时接受 1 种至 3 种抗癫痫药物治疗且伴有 FBTC 发作的年龄≥12 岁的亚洲患者的数据进行了分析，这些患者入组了 3 项普瑞巴林 3 期试验的长期扩展阶段（研究 307）或研究 335 的 10 周扩展阶段，以评估普瑞巴林对暴露持续时间、安全性和癫痫发作结局的影响。在纳入分析的 874 例亚洲患者中，205 例在 3 期双盲试验期间曾接受安慰剂治疗，669 例曾接受 2-12mg/天普瑞巴林治疗；313 例核心研究基线时伴有 FIAS 和 FBTC 发作。普瑞巴林暴露的中位持续时间为 385.0 天，1 年时的保留率为 62.6%。总体而言，在普瑞巴林治疗的前 52 周，777 例（88.9%）患者出现治疗时出现的不良事件（TEAEs），大多数为轻至中度严重程度。最常见的 TEAEs 是头晕（47.1%）、嗜睡（22.3%）和鼻咽炎（17.4%）。在普瑞巴林治疗的前 52 周，所有局灶性发作的 28 天发作频率中位数较基线时的变化百分比为-28.1%，伴有 FIAS 和 FBTC 发作的为-51.7%。与基线时相比，所有局灶性发作的 50%应答率为 33.8%，伴有 FIAS 和 FBTC 发作的为 51.1%。在亚洲患者中进行的普瑞巴林长期治疗具有与 3 期试验和扩展研究 307 中的全球人群相似的安全性、耐受性和疗效。安全性概况和反应率表明，该药对难治性癫痫的亚洲患者人群有益。
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