Early add-on

  • 文章类型: Journal Article
    背景:卒中后癫痫(PSE)是获得性癫痫的最常见原因之一。然而,关于PSE中抗癫痫药物(ASM)的临床特征的证据有限.这项研究旨在评估在现实世界中PSE患者仅用作附加治疗的perampanel(PER)的12个月有效性和耐受性。
    方法:我们对以前的回顾性研究中纳入的PSE患者进行了亚组分析,纵向,成人多中心观察性研究。停止治疗,收集3,6和12个月时的癫痫发作频率和不良事件.还进行了早期(≤1个先前的ASM)或晚期PER附加子分析。
    结果:我们的分析包括56名PSE患者,以相对于疾病发作的不同初始治疗方式和时间框架为特征。我们发现显著的保留率(92.8%,83.7%,在3、6和12个月时为69%),治疗退出主要是由于耐受性差。PER引入一年后,癫痫发作频率显著降低,应答率(减少≥50%)为83.9%,无癫痫发作率为51.6%。25例(46.3%)患者发生不良事件,主要是头晕,烦躁,和行为障碍。早期(30例患者,53.6%)和后期附加组,除了早期添加组的6个月应答率更高。
    结论:在真实世界环境中,辅助PER在PSE患者中是有效且耐受性良好的。Perampanel在早期和晚期附加治疗中表现出良好的疗效和安全性,使其成为这个独特的患者群体的一个令人信服的选择。
    BACKGROUND: Post-stroke epilepsy (PSE) is one of the most common causes of acquired epilepsy. Nevertheless, there is limited evidence regarding the clinical profile of antiseizure medications (ASMs) in PSE. This study aims to evaluate the 12-month effectiveness and tolerability of perampanel (PER) used as only add-on treatment in patients with PSE in a real-world setting.
    METHODS: We performed a subgroup analysis of PSE patients included in a previous retrospective, longitudinal, multicentre observational study on adults. Treatment discontinuation, seizure frequency and adverse events were collected at 3, 6 and 12 months. Sub-analyses by early (≤1 previous ASM) or late PER add-on were also conducted.
    RESULTS: Our analysis included 56 individuals with PSE, characterized by varying initial treatment modalities and timeframes relative to disease onset. We found notable retention rates (92.8%, 83.7%, and 69% at 3, 6, and 12 months), with treatment withdrawal mainly due to poor tolerability. One year after PER introduction, seizure frequency significantly reduced, with a responder rate (≥50% reduction) of 83.9% and a seizure-free rate of 51.6%. Adverse events occurred in 25 (46.3%) patients, mainly dizziness, irritability, and behavioural disorders. No major statistical differences were found between early (30 patients, 53.6%) and late add-on groups, except for a higher 6-month responder rate in the early add-on group.
    CONCLUSIONS: Adjunctive PER was effective and well-tolerated in patients with PSE in a real-world setting. Perampanel demonstrated good efficacy and safety as both early and late add-on treatment, making it a compelling option for this unique patient population.
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  • 文章类型: Journal Article
    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。
    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.
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  • 文章类型: Journal Article
    目的:癫痫持续状态(SE)定义为异常长时间的癫痫发作,可能导致脑损伤和死亡。我们的目的是评估静脉注射布立西坦(BRV)作为二线治疗的疗效和耐受性(有效性)。
    方法:在2019年6月至2022年12月期间,前瞻性招募了21名患者(中位年龄68岁±17.28)。患者接受BRV(50-200mg)作为SE的二线附加疗法。我们在6、12和24小时评估了SE终止和癫痫发作复发方面对BRV给药的反应,还监测安全。一线治疗以静脉注射苯二氮卓类药物(主要是地西泮)为代表。
    结果:几乎四分之一的患者有全身性癫痫发作,而绝大多数(76.2%)出现局灶性癫痫发作.在52.4%的患者中,根本原因是脑血管。14例(66.7%)患者在随后的6小时内表现出良好的早期反应。在12和24小时,8例(38%)和11例(52.4%)患者,分别,没有出现癫痫发作。
    结论:本研究强调了BRV作为SE的早期附加疗法的潜力,进一步确认其良好的安全性。
    OBJECTIVE: Status epilepticus (SE) is defined by abnormally prolonged seizures that may lead to brain damage and death. Our aim was to evaluate the efficacy and tolerability (effectiveness) of intravenous brivaracetam (BRV) as a second-line treatment.
    METHODS: Twenty-one patients (median age 68 years ± 17.28) were prospectively recruited between June 2019 and December 2022. Patients were treated with BRV (50-200 mg) as a second-line add-on therapy for SE. We evaluated the response of SE to the administration of BRV in terms of SE termination and recurrence of epileptic seizures at 6, 12, and 24 h, also monitoring safety. The first-line therapy was represented by intravenous benzodiazepines (mainly diazepam).
    RESULTS: Almost a quarter of patients had generalized seizures, whereas the vast majority (76.2%) presented focal seizures. In 52.4% of patients, the underlying cause was cerebrovascular. Fourteen (66.7%) patients displayed a good early response in the subsequent 6 h. At 12 and 24 h, 8 (38%) and 11 (52.4%) patients, respectively, did not present seizures.
    CONCLUSIONS: The present study highlights the potential of BRV when used as an early add-on therapy in SE, further confirming its good safety profile.
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  • 文章类型: Journal Article
    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。
    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.
    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. Sub-analyses by early or late use of PER and by concomitant ASM were also conducted.
    503 patients were included (age 36.5±19.9 years). Eighty-one per cent 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 sub-analyses, although patients who used PER as early add-on, as compared with late add-on, more often reached early seizure freedom at 3 months follow-up (66% vs. 53%, p=0.05). Treatment-emergent adverse events occurred in 25%, far less commonly than in PER randomized trials.
    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.
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  • 文章类型: Journal Article
    Perampanel (PER) has been shown to be effective as an adjunctive therapy for controlling refractory focal-onset seizures (FOS). However, the information as early add-on for the treatment of FOS in the clinical practice is still scarce and must be further assessed.
    An observational prospective study was conducted to evaluate the effectiveness of early add-on PER, assessed as 50% responders (seizure frequency reduced by at least 50% during the last 3 months as compared with baseline) rate at 6 and 12 months, in patients with FOS in the routine clinical practice of Spain.
    One hundred and thirteen patients (mean age: 40.3 years, 51.3% male) with FOS received PER as early add-on (1st add-on: 37.2% and 2nd: 62.8%) for a mean exposure of 11 months (mean PER dose: 6.3 mg/day at month 12). At 6 months, 50.4% and 20.4% of the patients were responders and seizure-free (respectively) relative to baseline (3 months prior to PER initiation), and at 12 months, 68.1% and 26.5% of the patients were responders and seizure-free (respectively), relative to baseline (3 months prior to PER initiation). The retention rate at 6 and 12 months was 83.2% and 80.5%, respectively. The percentage of seizure-free patients at 12 months was significantly (p = 0.033) higher when PER was added as first vs. second add-on. The number of concomitant antiepileptic drugs (AEDs) was significantly reduced from baseline to 6 and 12 months (p = 0.001). Treatment was simplified in 23.9% of patients at the end of the observation period. Drug-related adverse events (AEs), most mild or moderate, were reported in 30.1% of patients, with irritability (8%) and dizziness (7.1%) as the most frequent ones.
    This is the first observational, prospective study to evaluate efficacy and safety of early adjunctive treatment with PER in patients with focal epilepsy at 12 months. Perampanel demonstrated a good efficacy and safety profile when used at a median dose of 6 mg/day, regardless of the combination with other AEDs. Adverse events were mild or moderate, with dizziness being the most frequent one.
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