在12个月的辅助布里瓦拉塞坦治疗中,在现实生活环境中对焦发作患者的有效性:欧洲的一项前性观察性研究
Bernhard J Steinhoff1,2, Jakob Christensen3, Colin P Doherty4,5
1Kork Epilepsy Centre, Landstr. 1, 77694, Kehl-Kork, Germany. bsteinhoff@epilepsiezentrum.de.
Neurology and therapy
|February 20, 2025
概括
辅助布里瓦拉 (BRV) 在实际临床实践中对于焦点发作 (FOS) 证明了其有效性. 在12个月内57.7%的保留率表明BRV是难以治疗的的可行选择.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 随机对照试验确定了16岁及以上的患者治疗焦点发作 (FOS) 的辅助布里瓦拉 (BRV) 的疗效和耐受性.
- 这项研究评估了FOS患者 (≥16岁) 的辅助BRV在现实世界的有效性,有或没有焦点到双边强力克隆性发作.
研究的目的:
- 评估辅助布里瓦拉 (BRV) 在常规临床实践中对焦点发作 (FOS) 的有效性.
- 在现实世界患者群体中评估BRV保留率,响应率和自由度.
主要方法:
- 这是一项为期12个月的前性,现实,非干预性研究,在9个欧洲国家进行.
- 布里瓦拉塞坦 (BRV) 根据标准临床实践和欧洲产品特性总结规定.
- 主要终点是12个月后的BRV保留率;次要终点包括50%的响应率和的自由度.
主要成果:
- 在541名患者中,57.7%的患者在12个月内继续服用BRV,这表明在临床实践中保持良好.
- 二次结局结果显示,230名患者中有60.4%的患者有反应 (≥50%的发作减少),269名患者中有13.8%的患者实现了无发作.
- 36.0%的患者经历了治疗出现的不良事件 (TEAE),最常见的是药物无效和发作.
结论:
- 辅助布里瓦拉 (BRV) 在现实临床实践中对患有主要难以治疗的焦点发作 (FOS) 患者证明有效.
- 12个月的BRV保留率为57.7%,与其他新一代抗发作药物 (ASM) 观察到的实际保留率一致.
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