在临床实践中转换为溴瓦西坦单药治疗：回顾性研究

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2024-04-01 Epub Date: 2024-02-01 DOI:10.1007/s40120-024-00580-2

Simona Lattanzi, Nicoletta Foschi, Chiara Martellino, Daniela Audenino, Giovanni Boero, Paolo Bonanni, Edoardo Ferlazzo, Valentina Chiesa, Filippo Dainese, Marta Piccioli, Alessandra Ferrari, Angelo Labate

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引用次数: 0

摘要

简介：该研究旨在评估布利瓦西坦（BRV）作为转换单药在现实世界临床实践中治疗成人局灶性癫痫的有效性和安全性：该研究旨在评估在实际临床实践中，将溴瓦西坦（BRV）作为单药转换治疗成人局灶性癫痫的有效性和安全性：这是一项回顾性、观察性、非干预性研究，研究对象是在停用背景抗癫痫药物（ASMs）后改用 BRV 单药治疗的局灶性成人癫痫患者。主要疗效指标是 6 个月和 12 个月时 BRV 作为单一 ASM 的保留率。次要结果包括 6 个月和 12 个月的癫痫发作自由率。安全性和耐受性结果包括不良事件（AE）的频率和类型以及因不良事件而中断治疗的发生率：共纳入44名受试者，中位年龄为63.5岁（四分位数区间为44-73.5岁）；17名受试者基线时无癫痫发作，其中9名受试者因缺乏耐受性而改用左乙拉西坦治疗。6个月时，BRV单一疗法的保留率为88.6%（39/44），12个月时为83.9%（26/31）。随访6个月的受试者中，无癫痫发作率为72.7%（32/44），随访12个月的受试者中，无癫痫发作率为58.1%（18/31）。在6个月的随访中，BRV单一疗法的维持剂量中位数为每天150（100-200）毫克，在12个月的随访中，维持剂量中位数为每天125（100-200）毫克。6/44（13.6%）名受试者出现了不良反应，2/44（4.5%）名受试者因此停用了BRV。报告的不良反应包括嗜睡（3 例）、疲劳（2 例）和烦躁（1 例）；没有出现严重不良反应。21/44（47.7%）名参试者因直接更换左乙拉西坦而接受了 BRV 单药治疗。从左乙拉西坦转为BRV单药治疗的患者中，6个月和12个月的治疗保持率和癫痫发作自由度更高：结论：在现实生活中，对转为单药治疗的患者来说，布伐他塞坦可能是治疗局灶性癫痫发作的一种有效方法。

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Conversion to Brivaracetam Monotherapy in Clinical Practice: A Retrospective Study.

Introduction: The study aimed to evaluate the effectiveness and safety of brivaracetam (BRV) as conversion monotherapy in adults with focal epilepsy treated in the context of real-world clinical practice.

Methods: This was a retrospective, observational, non-interventional study in adults with focal epilepsy who converted to BRV monotherapy following the withdrawal of background antiseizure medications (ASMs). Primary effectiveness outcome was the retention rate of BRV as single ASM at 6 and 12 months. Secondary outcomes included the 6- and 12-month rates of seizure freedom. Safety and tolerability outcomes included the frequency and type of adverse events (AEs) and the occurrence of treatment discontinuation due to AEs.

Results: A total of 44 participants with a median age of 63.5 (interquartile range 44-73.5) years were included; 17 subjects were seizure free at baseline, and 9 of them switched from levetiracetam because of lack of tolerability. The retention rate of BRV monotherapy was 88.6% (39/44) at 6 months and 83.9% (26/31) at 12 months. The rates of seizure freedom were 72.7% (32/44) in subjects with 6-month follow-up and 58.1% (18/31) in subjects with 12-month follow-up. The median maintenance dosage of BRV monotherapy was 150 (100-200) mg/day at 6 months and 125 (100-200) mg/day in subjects with 12-month follow-up. Adverse events were recorded in 6/44 (13.6%) participants and led to BRV discontinuation in 2/44 (4.5%) cases. The reported AEs were somnolence (n = 3), fatigue (n = 2), and irritability (n = 1); no serious AEs were experienced. In 21/44 (47.7%) participants, BRV monotherapy resulted from the direct switch from levetiracetam. The rates of treatment retention and seizure freedom at 6 and 12 months were higher among people who switched from levetiracetam to BRV monotherapy.

Conclusion: Brivaracetam may be a valuable treatment of focal seizures in people who converted to monotherapy in a real-life setting.

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

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