在一个单中心回顾性研究中,在真实世界情景下的疗效、副作用和保留率的结果

IF 2.6 3区 心理学 Q2 BEHAVIORAL SCIENCES
Mostafa Badr, Christoph Helmstaedter, Susanna Moskau-Hartmann, Jan Pukropski, Juri-Alexander Witt, Theodor Rüber, Karmele Olaciregui Dague, Tobias Baumgartner, Michael Rademacher, Rainer Surges, Randi von Wrede
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引用次数: 0

摘要

背景药物耐药给癫痫患者带来了沉重的负担。最近获得批准的cenobamate (CNB)在III期和早期现实世界研究中报道了高疗效,给人们带来了新的希望。在这里,我们提供了来自一个合理规模的单中心队列的数据,补充了来自临床实践的知识。方法回顾性分析自进入市场至2023年7月31日所有接受CNB治疗的PWE的医疗记录。结果平均1.1年后,280名PWE中有262人接受了至少一剂CNB的随访数据。CNB的平均剂量为183±98 mg/d,平均抗癫痫药物(ASM)为2.9±1个。共有36%的患者癫痫发作频率降低≥50%(10.7%为无发作),而12.3%的患者癫痫发作频率增加。癫痫发作自由与伴随的perampanel或GABA受体调节剂有关。未发现治疗反应的预测因子。38%的人报告了副作用,其中警觉性问题最为普遍(19%)。保留率达72%,与反应状态、CNB剂量、副作用和引入CNB时的年龄有关。在停用CNB的患者中,55%的患者出现了副作用,89%的患者癫痫发作没有明显减少。关于联合用药,拉莫三嗪、布瓦西坦、氯巴赞或拉科沙胺的停药与更高的无反应率相关。结论在262名PWE的大队列中,CNB被证明是非常有效的,在一年多的时间里保持了很高的保留率。与perampanel或GABA受体调节剂联合用药与癫痫发作自由有关。中国央行的整体正面印象得到进一步支持。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Cenobamate in Real-Word Scenario: Results on Efficacy, Side Effects, and Retention Rate in a Single Center Retrospective Study

Background

Pharmacoresistance imposes a high burden on people with epilepsy (PWE). Recently authorized cenobamate (CNB) offers new hope with high efficacy reported in phase III and early real-world studies. Here, we present data from a reasonably sized monocentric cohort, complementing the knowledge derived from clinical practice.

Methods

We retrospectively analyzed medical records of all PWE treated with CNB from market entry to July 31, 2023.

Results

After an average of 1.1 years, follow-up data were available for 262 out of 280 PWE, who received at least one dose of CNB. The average CNB dose was 183 ± 98 mg/d, with a mean number of anti-seizure medications (ASM) of 2.9 ± 1 per patient. A total of 36% of the patients showed ≥ 50% reduction in seizure frequency (10.7% were seizure-free), whilst 12.3% reported increased seizure frequency. Seizure freedom was associated with concomitant perampanel or GABA receptor modulators. No predictors of treatment response were found. Side effects were reported by 38%, alertness issues being most prevalent (19%). The retention rate amounted to 72% and was associated with response status, dose of CNB, side effects, and age at CNB introduction. Among those who discontinued CNB, 55% experienced side effects and 89% showed no meaningful seizure reduction. Regarding co-medication, the withdrawal of lamotrigine, brivaracetam, clobazam, or lacosamide was associated with higher rates of non-response.

Conclusions

In this large cohort of 262 PWE, CNB proved very efficient with a high retention rate over one year. Co-medication with perampanel or GABA receptor modulators was linked to seizure-freedom. The overall positive impression of CNB is further supported.

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来源期刊
Brain and Behavior
Brain and Behavior BEHAVIORAL SCIENCES-NEUROSCIENCES
CiteScore
5.30
自引率
0.00%
发文量
352
审稿时长
14 weeks
期刊介绍: Brain and Behavior is supported by other journals published by Wiley, including a number of society-owned journals. The journals listed below support Brain and Behavior and participate in the Manuscript Transfer Program by referring articles of suitable quality and offering authors the option to have their paper, with any peer review reports, automatically transferred to Brain and Behavior. * [Acta Psychiatrica Scandinavica](https://publons.com/journal/1366/acta-psychiatrica-scandinavica) * [Addiction Biology](https://publons.com/journal/1523/addiction-biology) * [Aggressive Behavior](https://publons.com/journal/3611/aggressive-behavior) * [Brain Pathology](https://publons.com/journal/1787/brain-pathology) * [Child: Care, Health and Development](https://publons.com/journal/6111/child-care-health-and-development) * [Criminal Behaviour and Mental Health](https://publons.com/journal/3839/criminal-behaviour-and-mental-health) * [Depression and Anxiety](https://publons.com/journal/1528/depression-and-anxiety) * Developmental Neurobiology * [Developmental Science](https://publons.com/journal/1069/developmental-science) * [European Journal of Neuroscience](https://publons.com/journal/1441/european-journal-of-neuroscience) * [Genes, Brain and Behavior](https://publons.com/journal/1635/genes-brain-and-behavior) * [GLIA](https://publons.com/journal/1287/glia) * [Hippocampus](https://publons.com/journal/1056/hippocampus) * [Human Brain Mapping](https://publons.com/journal/500/human-brain-mapping) * [Journal for the Theory of Social Behaviour](https://publons.com/journal/7330/journal-for-the-theory-of-social-behaviour) * [Journal of Comparative Neurology](https://publons.com/journal/1306/journal-of-comparative-neurology) * [Journal of Neuroimaging](https://publons.com/journal/6379/journal-of-neuroimaging) * [Journal of Neuroscience Research](https://publons.com/journal/2778/journal-of-neuroscience-research) * [Journal of Organizational Behavior](https://publons.com/journal/1123/journal-of-organizational-behavior) * [Journal of the Peripheral Nervous System](https://publons.com/journal/3929/journal-of-the-peripheral-nervous-system) * [Muscle & Nerve](https://publons.com/journal/4448/muscle-and-nerve) * [Neural Pathology and Applied Neurobiology](https://publons.com/journal/2401/neuropathology-and-applied-neurobiology)
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