Abstract：
BACKGROUND: Drug management of epilepsy in the elderly presents unique but data on this population are scarce. This study aimed to assess the effectiveness and tolerability of perampanel (PER) used as only add-on to a background anti-seizure medication (ASM) in the elderly in a real-world setting.
METHODS: We performed a subgroup analysis of patients aged ≥65 years included in a previous 12-month multicenter study on adults. Treatment discontinuation, seizure frequency, and adverse events were recorded at 3, 6 and 12 months after PER introduction. Sub-analyses by early (≤1 previous ASM) or late PER add-on were also conducted.
RESULTS: The sample included 65 subjects (mean age: 75.7 ± 7.2 years), with mainly focal (73.8%) epilepsy. The mean PER daily dose was ≈4 mg during all follow-up. Retention rates at 3, 6, and 12 months were 90.5%, 89.6%, and 79.4%ly. The baseline median normalized per 28-day seizure number significantly decreased at 3-, 6- and 12-month visits. One year after PER introduction, the responder rate (≥50% reduction in baseline seizure frequency) was 89.7%, with a seizure freedom rate of 72.4%. Adverse events occurred in 22 (34.9%) patients with dizziness and irritability being the most frequent. No major differences between early (41 patients, 63.1%), and late add-on groups were observed.
CONCLUSIONS: Adjunctive PER was effective and well-tolerated when used as only add-on treatment in elderly people with epilepsy in clinical practice, thus representing a suitable therapeutic option in this age category.
METHODS: We performed a subgroup analysis of patients aged ≥65 years included in a previous 12-month multicenter study on adults. Treatment discontinuation, seizure frequency, and adverse events were recorded at 3, 6 and 12 months after PER introduction. Sub-analyses by early (≤1 previous ASM) or late PER add-on were also conducted.
RESULTS: The sample included 65 subjects (mean age: 75.7 ± 7.2 years), with mainly focal (73.8%) epilepsy. The mean PER daily dose was ≈4 mg during all follow-up. Retention rates at 3, 6, and 12 months were 90.5%, 89.6%, and 79.4%ly. The baseline median normalized per 28-day seizure number significantly decreased at 3-, 6- and 12-month visits. One year after PER introduction, the responder rate (≥50% reduction in baseline seizure frequency) was 89.7%, with a seizure freedom rate of 72.4%. Adverse events occurred in 22 (34.9%) patients with dizziness and irritability being the most frequent. No major differences between early (41 patients, 63.1%), and late add-on groups were observed.
CONCLUSIONS: Adjunctive PER was effective and well-tolerated when used as only add-on treatment in elderly people with epilepsy in clinical practice, thus representing a suitable therapeutic option in this age category.
摘要：
背景：老年人癫痫的药物管理是独特的，但关于这一人群的数据很少。这项研究旨在评估在现实世界中，仅用作老年人背景抗癫痫药物（ASM）的潘帕奈尔（PER）的有效性和耐受性。
方法：我们对先前12个月多中心成人研究中年龄≥65岁的患者进行了亚组分析。停止治疗,癫痫发作频率,并在引入PER后3,6和12个月记录不良事件.还进行了早期(≤1个先前的ASM)或晚期PER附加子分析。
结果：样本包括65名受试者（平均年龄：75.7±7.2岁），以局灶性癫痫为主（73.8%）。在所有随访期间，平均PER日剂量约为4mg。3、6和12个月的保留率为90.5%，89.6%,79.4%。基线中位数标准化每28天癫痫发作次数显着下降3,6个月和12个月的访问。PER引入一年后，应答率（基线发作频率降低≥50%）为89.7%，癫痫发作自由率为72.4%。不良事件发生在22例（34.9％）患者中，头晕和烦躁最常见。早期(41例患者，63.1%），并观察到后期添加组。
结论：在临床实践中，辅助PER仅用作老年癫痫患者的附加治疗时有效且耐受性良好，因此代表了该年龄段的合适治疗选择。
方法：我们对先前12个月多中心成人研究中年龄≥65岁的患者进行了亚组分析。停止治疗,癫痫发作频率,并在引入PER后3,6和12个月记录不良事件.还进行了早期(≤1个先前的ASM)或晚期PER附加子分析。
结果：样本包括65名受试者（平均年龄：75.7±7.2岁），以局灶性癫痫为主（73.8%）。在所有随访期间，平均PER日剂量约为4mg。3、6和12个月的保留率为90.5%，89.6%,79.4%。基线中位数标准化每28天癫痫发作次数显着下降3,6个月和12个月的访问。PER引入一年后，应答率（基线发作频率降低≥50%）为89.7%，癫痫发作自由率为72.4%。不良事件发生在22例（34.9％）患者中，头晕和烦躁最常见。早期(41例患者，63.1%），并观察到后期添加组。
结论：在临床实践中，辅助PER仅用作老年癫痫患者的附加治疗时有效且耐受性良好，因此代表了该年龄段的合适治疗选择。
