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在真实世界中,根据合并症和病因对癫痫患者进行分层,评估 brivaracetam 的有效性和耐受性:来自国际 EXPERIENCE 汇总分析的 12 个月亚组数据。

Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis.

机构信息

University of Alabama at Birmingham (UAB) Heersink School of Medicine Department of Neurology and UAB Epilepsy Center, Birmingham, AL, USA.

UCB Pharma, Breda, Netherlands.

出版信息

J Neurol. 2024 Jun;271(6):3169-3185. doi: 10.1007/s00415-024-12253-z. Epub 2024 Mar 4.

Abstract

OBJECTIVE

To assess the effectiveness and tolerability of brivaracetam (BRV) in adults with epilepsy by specific comorbidities and epilepsy etiologies.

METHODS

EXPERIENCE/EPD332 was a pooled analysis of individual patient records from several non-interventional studies of patients with epilepsy initiating BRV in clinical practice. Outcomes included ≥ 50% reduction from baseline in seizure frequency, seizure freedom (no seizures within prior 3 months), continuous seizure freedom (no seizures since baseline), BRV discontinuation, and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Analyses were performed for all adult patients (≥ 16 years of age) and stratified by comorbidity and by etiology at baseline (patients with cognitive/learning disability [CLD], psychiatric comorbidity, post-stroke epilepsy, brain tumor-related epilepsy [BTRE], and traumatic brain injury-related epilepsy [TBIE]).

RESULTS

At 12 months, ≥ 50% seizure reduction was achieved in 35.6% (n = 264), 38.7% (n = 310), 41.7% (n = 24), 34.1% (n = 41), and 50.0% (n = 28) of patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, respectively; and continuous seizure freedom was achieved in 5.7% (n = 318), 13.7% (n = 424), 29.4% (n = 34), 11.4% (n = 44), and 13.8% (n = 29), respectively. During the study follow-up, in patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, 37.1% (n = 403), 30.7% (n = 605), 33.3% (n = 51), 39.7% (n = 68), and 27.1% (n = 49) of patients discontinued BRV, respectively; and TEAEs since prior visit at 12 months were reported in 11.3% (n = 283), 10.0% (n = 410), 16.7% (n = 36), 12.5% (n = 48), and 3.0% (n = 33), respectively.

CONCLUSIONS

BRV as prescribed in the real world is effective and well tolerated among patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE.

摘要

目的

评估布里瓦卡坦(BRV)在具有特定合并症和癫痫病因的癫痫成人患者中的疗效和耐受性。

方法

经验/ EPD332 是对临床实践中开始使用 BRV 的癫痫患者的几项非干预性研究的个体患者记录进行的汇总分析。结果包括从基线时发作频率减少≥ 50%,发作无(过去 3 个月内无发作),持续无发作(自基线以来无发作),BRV 停药以及在 3、6 和 12 个月时出现治疗中出现的不良事件(TEAEs)。对所有成年患者(≥ 16 岁)进行了分析,并根据基线时的合并症和病因进行分层(有认知/学习障碍[CLD],精神病合并症,中风后癫痫,脑肿瘤相关癫痫[BTRE]和创伤性脑损伤相关癫痫[TBIE])。

结果

在 12 个月时,CLD,精神病合并症,中风后癫痫,BTRE 和 TBIE 的患者中,分别有 35.6%(n = 264),38.7%(n = 310),41.7%(n = 24),34.1%(n = 41)和 50.0%(n = 28)的患者达到≥ 50%的癫痫发作减少率;分别有 5.7%(n = 318),13.7%(n = 424),29.4%(n = 34),11.4%(n = 44)和 13.8%(n = 29)的患者达到持续无发作率。在研究随访期间,CLD,精神病合并症,中风后癫痫,BTRE 和 TBIE 的患者中,分别有 37.1%(n = 403),30.7%(n = 605),33.3%(n = 51),39.7%(n = 68)和 27.1%(n = 49)的患者停止了 BRV 治疗;并且在 12 个月时,有 11.3%(n = 283),10.0%(n = 410),16.7%(n = 36),12.5%(n = 48)和 3.0%(n = 33)的患者报告了治疗后出现新的不良事件。

结论

BRV 在现实世界中的处方在具有 CLD,精神病合并症,中风后癫痫,BTRE 和 TBIE 的患者中是有效且耐受良好的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e00a/11136785/6a787a186dca/415_2024_12253_Fig1_HTML.jpg

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