Caregiver-reported non-seizure and seizure outcomes with cannabidiol and clobazam in patients aged ≥2 years with Lennox-Gastaut syndrome or Dravet syndrome: A subgroup analysis of the BECOME survey

IF 2.7 3区医学 Q2 CLINICAL NEUROLOGY

Seizure-European Journal of Epilepsy Pub Date : 2025-05-03 DOI:10.1016/j.seizure.2025.04.017

M. Scott Perry , Tracy Dixon-Salazar , Mary Anne Meskis , Sherry R. Danese , Timothy B. Saurer , Kishan Vyas , Anne T. Berg

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引用次数: 0

Abstract

Purpose

This subgroup analysis of the BECOME (BEhavior, COgnition, and More with Epidiolex®) survey analyzed caregiver-reported seizure and non-seizure outcomes, including changes in caregiver burden, following cannabidiol (CBD) treatment in patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) aged ≥2 years taking concomitant clobazam, aligned with the European Medicines Agency indication.

Methods

US-based caregivers of patients with LGS/DS receiving CBD (Epidiolex®, 100 mg/mL oral solution) for ≥3 months rated patient outcome changes, comparing the previous month with pre-CBD initiation. Multiple-choice and rank-order questions with symmetrical 3-, 5-, or 7-point scales ranging from worsening to improvement were used.

Results

Patients (N = 243; 76 % LGS, 24 % DS; 52 % male; mean [range] age 15 [2–53] years) took a median of 14 mg/kg/day CBD and a median of four other antiseizure medications, including clobazam. Caregivers reported improvements in seizure frequency (87 %), severity (81 %), and weekly seizure-free days (net improvement across seizure types 68 %). Caregivers noted improvements in ≥1 question for non-seizure domains (net data across questions within each domain): alertness, cognition, and executive function (84 %); language and communication in non-verbal (81 %) and verbal (76 %) patients; emotional and social functioning (79 %); daily activities (56 %); physical functioning (44 %); and sleep (56 %). Additionally, 4–26 % of caregivers (net) reported worsening in ≥1 question in any domain. Overall, 94 % of caregivers planned to continue CBD treatment.

Conclusions

Consistent with the overall BECOME survey, most caregivers of patients with LGS/DS aged ≥2 years taking concomitant clobazam reported improvements in seizure and non-seizure outcomes since initiating CBD treatment.

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护理人员报告的≥2岁lenox - gastaut综合征或Dravet综合征患者使用大麻二酚和氯巴赞的非癫痫发作和癫痫发作结果：成为调查的亚组分析

目的：根据欧洲药品管理局的适应症，对年龄≥2岁的Lennox-Gastaut综合征（LGS）或Dravet综合征（DS）患者同时服用氯巴唑，进行大麻二酚（CBD）治疗后，护理人员报告的癫痫和非癫痫结果进行亚组分析，包括护理人员负担的变化。方法LGS/DS患者接受CBD （Epidiolex®，100 mg/mL口服溶液）治疗≥3个月后，基于sus的护理人员评价患者的预后变化，并将前一个月与CBD开始前进行比较。采用从恶化到改善的对称3、5或7分制的多项选择题和顺序题。结果患者243例；76%的男性，24%的女性；52%男性；平均[范围]15岁[2-53]岁)服用CBD的中位数为14 mg/kg/天，以及其他四种抗癫痫药物的中位数，包括氯巴唑。护理人员报告了癫痫发作频率（87%）、严重程度（81%）和每周无癫痫发作天数（所有癫痫发作类型的净改善率为68%）的改善。护理人员注意到非癫痫领域的≥1个问题的改善（每个领域内问题的净数据）：警觉性、认知和执行功能（84%）；非语言（81%）和语言（76%）患者的语言和交流；情感和社会功能（79%）；日常活动（56%）；身体功能（44%）；还有睡眠（56%）。此外，4 - 26%的护理人员（净）报告在任何领域中有≥1个问题恶化。总体而言，94%的护理人员计划继续进行CBD治疗。结论：与整体调查结果一致，大多数年龄≥2岁的LGS/DS患者的护理人员报告说，自开始使用CBD治疗以来，癫痫发作和非癫痫发作结果有所改善。

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来源期刊

Seizure-European Journal of Epilepsy 医学-临床神经学

CiteScore

5.60

自引率

6.70%

发文量

231

审稿时长

34 days

期刊介绍： Seizure - European Journal of Epilepsy is an international journal owned by Epilepsy Action (the largest member led epilepsy organisation in the UK). It provides a forum for papers on all topics related to epilepsy and seizure disorders.