PDF(Pubmed)
Abstract：
OBJECTIVE: Perampanel (PER) is indicated as adjunctive antiseizure medication (ASM) in adolescents and adults with epilepsy. Data from clinical trials show good efficacy and tolerability, while limited information is available on the routine clinical use of PER, especially when used as only add-on treatment.
METHODS: We performed an observational, retrospective, multicenter study on people with focal or generalized epilepsy aged >12 years, consecutively recruited from 52 Italian epilepsy centers. All patients received PER as the only add-on treatment to a background ASM according to standard clinical practice. Retention rate, seizure frequency, and adverse events were recorded at 3, 6, and 12 months after PER introduction. Subanalyses by early or late use of PER and by concomitant ASM were also conducted.
RESULTS: Five hundred and three patients were included (age 36.5 ± 19.9 years). Eighty-one percent had focal epilepsy. Overall, the retention rate was very high in the whole group (89% at 12 months) according with efficacy measures. No major differences were observed in the subanalyses, although patients who used PER as early add-on, as compared with late add-on, more often reached early seizure freedom at 3-month follow-up (66% vs 53%, P = .05). Treatment-emergent adverse events occurred in 25%, far less commonly than in PER randomized trials.
CONCLUSIONS: This study confirms the good efficacy and safety of PER for focal or generalized epilepsy in real-life conditions. We provide robust data about its effectiveness as only add-on treatment even in patients with a long-standing history of epilepsy and previously treated with many ASMs.
METHODS: We performed an observational, retrospective, multicenter study on people with focal or generalized epilepsy aged >12 years, consecutively recruited from 52 Italian epilepsy centers. All patients received PER as the only add-on treatment to a background ASM according to standard clinical practice. Retention rate, seizure frequency, and adverse events were recorded at 3, 6, and 12 months after PER introduction. Subanalyses by early or late use of PER and by concomitant ASM were also conducted.
RESULTS: Five hundred and three patients were included (age 36.5 ± 19.9 years). Eighty-one percent had focal epilepsy. Overall, the retention rate was very high in the whole group (89% at 12 months) according with efficacy measures. No major differences were observed in the subanalyses, although patients who used PER as early add-on, as compared with late add-on, more often reached early seizure freedom at 3-month follow-up (66% vs 53%, P = .05). Treatment-emergent adverse events occurred in 25%, far less commonly than in PER randomized trials.
CONCLUSIONS: This study confirms the good efficacy and safety of PER for focal or generalized epilepsy in real-life conditions. We provide robust data about its effectiveness as only add-on treatment even in patients with a long-standing history of epilepsy and previously treated with many ASMs.
摘要：
Perampanel（PER）被认为是青少年和成人癫痫患者的辅助抗癫痫药物（ASM）。临床试验数据显示良好的疗效和耐受性，虽然关于PER常规临床使用的信息有限，特别是当用作唯一的附加治疗。
我们进行了观察，回顾性,年龄>12岁的局灶性或全身性癫痫患者的多中心研究，从52个意大利癫痫中心连续招募。根据标准临床实践，所有患者均接受PER作为背景ASM的唯一附加治疗。保留率，在引入PER后3,6和12个月记录癫痫发作频率和不良事件.还通过早期或晚期使用PER和伴随的ASM进行了亚分析。
503例患者（年龄36.5±19.9岁）。81%患有局灶性癫痫。总的来说,根据疗效指标,全组的保留率非常高(12个月时为89%).在子分析中没有观察到重大差异，虽然使用PER作为早期附加的患者，与后期附加相比，更常见的是在3个月随访时达到早期癫痫发作的自由(66%vs.53%,p=0.05)。治疗引起的不良事件发生率为25%，远低于PER随机试验。
这项研究证实了在现实生活中，PER对局灶性或全身性癫痫的良好疗效和安全性。
我们进行了观察，
503例患者（年龄36.5±19.9岁）。
这项研究证实了在现实生活中，PER对局灶性或全身性癫痫的良好疗效和安全性。
