Abstract：
OBJECTIVE: To examine the efficacy and safety of perampanel (PER) in patients with post-stroke epilepsy (PSE), brain tumor-related epilepsy (BTRE), and post-traumatic epilepsy (PTE) using Japanese real-world data.
METHODS: The prospective post-marketing observational study included patients with focal seizures with or without focal to bilateral tonic-clonic seizures who received PER combination therapy. The observation period was 24 or 52 weeks after the initial PER administration. The safety and efficacy analysis included 3716 and 3272 patients, respectively. This post hoc analysis examined responder rate (50% reduction in seizure frequency), seizure-free rate (proportion of patients who achieved seizure-free), and safety in patients included in the post-marketing study who had PSE, BTRE, and PTE in the 4 weeks prior to the last observation.
RESULTS: Overall, 402, 272, and 186 patients were included in the PSE, BTRE, and PTE subpopulations, and 2867 controls in the \"Other\" population (etiologies other than PSE, BTRE, or PTE). Mean modal dose (the most frequently administered dose) values at 52 weeks were 3.38, 3.36, 3.64, and 4.04 mg/day for PSE, BTRE, PTE, and \"Other,\" respectively; PER retention rates were 56.2%, 54.0%, 52.6%, and 59.7%, respectively. Responder rates (% [95% confidence interval]) were 82% (76.3%-86.5%), 78% (70.8%-83.7%), 67% (56.8%-75.6%), and 50% (47.9%-52.7%) for PSE, BTRE, PTE, and \"Other,\" respectively, and seizure-free rates were 71% (64.5%-76.5%), 62% (54.1%-69.0%), 50% (40.6%-60.4%), and 28% (25.8%-30.1%), respectively. Adverse drug reactions tended to occur less frequently in the PSE (14.7%), BTRE (16.5%), and PTE (16.7%) subpopulations than in the \"Other\" population (26.3%).
CONCLUSIONS: In real-world clinical conditions, efficacy and tolerability for PER combination therapy were observed at low PER doses for the PSE, BTRE, and PTE subpopulations.
CONCLUSIONS: To find out how well the medication perampanel works and whether it is safe for people who have epilepsy after having had a stroke, brain tumor, or head injury, we used information from real-life medical situations in Japan. We looked at the data of about 3700 Japanese patients with epilepsy who were treated with perampanel. We found that perampanel was used at lower doses and better at controlling seizures, and had fewer side effects for patients with epilepsy caused by these etiologies than the control group.
METHODS: The prospective post-marketing observational study included patients with focal seizures with or without focal to bilateral tonic-clonic seizures who received PER combination therapy. The observation period was 24 or 52 weeks after the initial PER administration. The safety and efficacy analysis included 3716 and 3272 patients, respectively. This post hoc analysis examined responder rate (50% reduction in seizure frequency), seizure-free rate (proportion of patients who achieved seizure-free), and safety in patients included in the post-marketing study who had PSE, BTRE, and PTE in the 4 weeks prior to the last observation.
RESULTS: Overall, 402, 272, and 186 patients were included in the PSE, BTRE, and PTE subpopulations, and 2867 controls in the \"Other\" population (etiologies other than PSE, BTRE, or PTE). Mean modal dose (the most frequently administered dose) values at 52 weeks were 3.38, 3.36, 3.64, and 4.04 mg/day for PSE, BTRE, PTE, and \"Other,\" respectively; PER retention rates were 56.2%, 54.0%, 52.6%, and 59.7%, respectively. Responder rates (% [95% confidence interval]) were 82% (76.3%-86.5%), 78% (70.8%-83.7%), 67% (56.8%-75.6%), and 50% (47.9%-52.7%) for PSE, BTRE, PTE, and \"Other,\" respectively, and seizure-free rates were 71% (64.5%-76.5%), 62% (54.1%-69.0%), 50% (40.6%-60.4%), and 28% (25.8%-30.1%), respectively. Adverse drug reactions tended to occur less frequently in the PSE (14.7%), BTRE (16.5%), and PTE (16.7%) subpopulations than in the \"Other\" population (26.3%).
CONCLUSIONS: In real-world clinical conditions, efficacy and tolerability for PER combination therapy were observed at low PER doses for the PSE, BTRE, and PTE subpopulations.
CONCLUSIONS: To find out how well the medication perampanel works and whether it is safe for people who have epilepsy after having had a stroke, brain tumor, or head injury, we used information from real-life medical situations in Japan. We looked at the data of about 3700 Japanese patients with epilepsy who were treated with perampanel. We found that perampanel was used at lower doses and better at controlling seizures, and had fewer side effects for patients with epilepsy caused by these etiologies than the control group.
摘要：
目的：为了检查潘帕奈尔（PER）对卒中后癫痫（PSE）患者的疗效和安全性，脑肿瘤相关癫痫（BTRE），和创伤后癫痫（PTE）使用日本现实世界的数据。
方法：前瞻性上市后观察性研究纳入了接受PER联合治疗的局灶性癫痫发作伴或不伴双侧强直阵挛性癫痫发作的患者。观察期为初次PER给药后24或52周。安全性和有效性分析包括3716例和3272例患者，分别。这个事后分析检查了应答率(癫痫发作频率减少50%)，无癫痫发作率（实现无癫痫发作的患者比例），以及上市后研究中患有PSE的患者的安全性，BTRE,和PTE在最后一次观察前4周。
结果：总体而言，402、272和186名患者被纳入PSE，BTRE,和PTE亚群，和“其他”人群中的2867名对照(PSE以外的病因，BTRE,或PTE）。PSE在52周时的平均模式剂量（最常给药剂量）值为3.38、3.36、3.64和4.04mg/天，BTRE,PTE,和“其他，“；PER保留率为56.2%，54.0%,52.6%,和59.7%，分别。响应者比率(%[95%置信区间])为82%(76.3%-86.5%)，78%（70.8%-83.7%），67%（56.8%-75.6%），和50%(47.9%-52.7%)的PSE，BTRE,PTE,和“其他，\"分别，无癫痫发生率为71%(64.5%-76.5%)，62%（54.1%-69.0%），50%（40.6%-60.4%），和28%(25.8%-30.1%)，分别。药物不良反应在PSE中发生频率较低（14.7％），BTRE（16.5%），和PTE（16.7%）亚群比“其他”群体（26.3%）。
结论：在现实世界的临床条件下，在PSE的低PER剂量下观察到PER联合治疗的疗效和耐受性，BTRE,和PTE亚群。
结论：为了了解药物perampanel的效果，以及对中风后癫痫患者是否安全，脑肿瘤,或者头部受伤,我们使用了来自日本真实医疗情况的信息。我们查看了约3700名接受perampanel治疗的日本癫痫患者的数据。我们发现perampanel的剂量较低，在控制癫痫发作方面效果更好，与对照组相比，由这些病因引起的癫痫患者的副作用更少。
方法：前瞻性上市后观察性研究纳入了接受PER联合治疗的局灶性癫痫发作伴或不伴双侧强直阵挛性癫痫发作的患者。观察期为初次PER给药后24或52周。安全性和有效性分析包括3716例和3272例患者，分别。这个事后分析检查了应答率(癫痫发作频率减少50%)，无癫痫发作率（实现无癫痫发作的患者比例），以及上市后研究中患有PSE的患者的安全性，BTRE,和PTE在最后一次观察前4周。
结果：总体而言，402、272和186名患者被纳入PSE，BTRE,和PTE亚群，和“其他”人群中的2867名对照(PSE以外的病因，BTRE,或PTE）。PSE在52周时的平均模式剂量（最常给药剂量）值为3.38、3.36、3.64和4.04mg/天，BTRE,PTE,和“其他，“；PER保留率为56.2%，54.0%,52.6%,和59.7%，分别。响应者比率(%[95%置信区间])为82%(76.3%-86.5%)，78%（70.8%-83.7%），67%（56.8%-75.6%），和50%(47.9%-52.7%)的PSE，BTRE,PTE,和“其他，\"分别，无癫痫发生率为71%(64.5%-76.5%)，62%（54.1%-69.0%），50%（40.6%-60.4%），和28%(25.8%-30.1%)，分别。药物不良反应在PSE中发生频率较低（14.7％），BTRE（16.5%），和PTE（16.7%）亚群比“其他”群体（26.3%）。
结论：在现实世界的临床条件下，在PSE的低PER剂量下观察到PER联合治疗的疗效和耐受性，BTRE,和PTE亚群。
结论：为了了解药物perampanel的效果，以及对中风后癫痫患者是否安全，脑肿瘤,或者头部受伤,我们使用了来自日本真实医疗情况的信息。我们查看了约3700名接受perampanel治疗的日本癫痫患者的数据。我们发现perampanel的剂量较低，在控制癫痫发作方面效果更好，与对照组相比，由这些病因引起的癫痫患者的副作用更少。
