在日本参与者中预防性治疗偏头痛的Atogepant:第三阶段,开放标签,52周的延期研究
Yasuhiko Matsumori1, Krisztian Nagy2, Akihiro Takahashi3
1Sendai Headache and Neurology Clinic, Sendai, Miyagi, Japan.
Neurology and therapy
|March 12, 2026
概括
在日本的偏头痛患者中,Atogepant在52周内表现出一致的安全性,没有新的安全问题. 在整个研究过程中,有效性和功能性改善一直保持不变.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 阿托杰潘特是一种口服的素基因相关的受体对抗剂,用于预防偏头痛.
- 在美国,欧盟和日本批准用于成人偏头痛治疗.
研究的目的:
- 评估日本偏头痛患者中阿托基潘特的长期安全性,疗效和功能结果.
- 评估Atogepant 60毫克每天一次,持续52周.
主要方法:
- 开放标签,52周的安全延长研究.
- 包括患有慢性偏头痛 (CM) 和新发性偏头痛 (EM) 的参与者.
- 主要目标:安全性和耐受性;次要:疗效和功能结果.
主要成果:
- 186名参与者被录取;88.7%的人经历了治疗出现的不良事件 (TEAE).
- 最常见的TEAE:发烧症,鼻炎,便秘. 在3.8%的严重TEAE中,没有一个被认为与atogepant有关.
- 在CM和EM组中,在52周内观察到每月偏头痛日数的持续减少.
结论:
- 在日本参与者中Atogepant的安全概况与全球数据一致;没有发现新的安全信号.
- 在52周的治疗期间,疗效和功能结果的改善持续了.
- 阿托基潘特是一种安全有效的长期预防治疗日本成年人的偏头痛.
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