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布瓦西坦添加治疗卒中后癫痫患者:BRIVAracetam 添加第一项意大利网络研究(BRIVAFIRST)的真实世界数据。

Brivaracetam as add-on treatment in patients with post-stroke epilepsy: real-world data from the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST).

机构信息

Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.

Department of Epileptology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

出版信息

Seizure. 2022 Apr;97:37-42. doi: 10.1016/j.seizure.2022.03.007. Epub 2022 Mar 10.

Abstract

OBJECTIVE

Post-stroke epilepsy (PSE) is one of the most common causes of acquired epilepsy and accounts for about 10-15% of all newly diagnosed epilepsy cases. However, evidence about the clinical profile of antiseizure medications in the PSE setting is currently limited. Brivaracetam (BRV) is a rationally developed compound characterized by high-affinity binding to synaptic vesicle protein 2A. The aim of this study was to assess the 12-month effectiveness and tolerability of adjunctive BRV in patients with PSE treated in a real-world setting.

METHODS

This was a subgroup analysis of patients with PSE included in the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST). The BRIVAFIRST was a 12-month retrospective, multicentre study including adult patients prescribed adjunctive BRV. Effectiveness outcomes included the rates of seizure response (≥50% reduction in baseline seizure frequency), seizure-freedom, and treatment discontinuation. Safety and tolerability outcomes included the rate of treatment discontinuation due to adverse events (AEs) and the incidence of AEs.

RESULTS

Patients with PSE included in the BRIVAFIRST were 75 and had a median age of 57 (interquartile range, 42-66) years. The median daily doses of BRV at 3, 6, and 12 months from starting treatment were 100 (100-150) mg, 125 (100-200) mg and 100 (100-200) mg, respectively. At 12 months, 32 (42.7%) patients had a reduction in their baseline seizure frequency by at least 50%, and the seizure freedom rates was 26/75 (34.7%). During the 1-year study period, 10 (13.3%) patients discontinued BRV. The reasons of treatment withdrawal were insufficient efficacy in 6 (8.0%) patients and poor tolerability in 4 (5.3%) patients. Adverse events were reported by 13 (20.3%) patients and were rated as mild in 84.6% and moderate in 15.4% of cases.

SIGNIFICANCE

Adjunctive BRV was efficacious and generally well-tolerated when used in patients with PSE in clinical practice. Adjunctive BRV can be a suitable therapeutic option for patients with PSE.

摘要

目的

卒中后癫痫(PSE)是获得性癫痫最常见的原因之一,约占所有新诊断癫痫病例的 10-15%。然而,目前关于 PSE 环境中抗癫痫药物的临床特征的证据有限。布瓦雷西坦(BRV)是一种合理开发的化合物,其特点是与突触囊泡蛋白 2A 具有高亲和力结合。本研究旨在评估 BRV 辅助治疗 PSE 患者的 12 个月有效性和耐受性。

方法

这是 BRIVAracetam 附加意大利首个网络研究(BRIVAFIRST)中纳入的 PSE 患者的亚组分析。BRIVAFIRST 是一项为期 12 个月的回顾性、多中心研究,包括接受 BRV 辅助治疗的成年患者。有效性结果包括癫痫发作缓解率(基线癫痫发作频率降低≥50%)、无癫痫发作率和治疗停药率。安全性和耐受性结果包括因不良事件(AE)停药率和 AE 发生率。

结果

BRIVAFIRST 中纳入的 PSE 患者为 75 例,中位年龄为 57 岁(四分位间距,42-66)。从开始治疗的第 3、6 和 12 个月,BRV 的中位日剂量分别为 100(100-150)mg、125(100-200)mg 和 100(100-200)mg。在 12 个月时,32(42.7%)例患者的基线癫痫发作频率降低至少 50%,无癫痫发作率为 26/75(34.7%)。在 1 年研究期间,10(13.3%)例患者停用 BRV。停药的原因是 6(8.0%)例患者疗效不足,4(5.3%)例患者耐受性差。13(20.3%)例患者报告发生不良事件,84.6%为轻度,15.4%为中度。

意义

BRV 辅助治疗在临床实践中对 PSE 患者有效且耐受性良好。BRV 辅助治疗可能是 PSE 患者的一种合适的治疗选择。

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