使用FDA不良事件报告系统评估与Ubrogepant相关的不良事件
Bing Cao1, Shanshan Gu1, Zhisen Shen1
1Department of Otorhinolaryngology Head and Neck Surgery, Lihuili Hospital affiliated to Ningbo University, Ningbo, Zhejiang, China.
Expert opinion on drug safety
|August 23, 2023
概括
这项研究分析了Ubrogepant的安全数据,确定了以前未报告的不良事件. 这些发现增强了对Ubrogepant的理解.
科学领域:
- 药物监督 药物监督 药物监督
- 临床安全研究 临床安全研究
- 神经学 神经学
背景情况:
- 偏头痛是一种流行的主要头痛疾病,影响了12%的人口.
- 乌布罗杰潘特是一种治疗急性偏头痛的药物,现有试验表明其安全性.
- 在大群体中Ubrogepant的长期安全数据需要进一步调查.
研究的目的:
- 为了调查Ubrogepant的长期安全性概况.
- 为了确定与Ubrogepant使用相关的潜在不良事件.
- 为Ubrogepant提供全面的安全见解.
主要方法:
- 使用了美国食品和药物管理局不良事件报告系统 (FAERS) 数据库.
- 采用了统计方法,包括报告几率比率 (ROR),比例报告比率 (PRR),信息组件 (IC) 和实证贝叶斯几何平均值 (EBGM).
- 分析了2,067份报告,其中Ubrogepant是主要的可疑药物,以及6,190份Ubrogepant诱导的不良事件报告.
主要成果:
- 在9个系统器官类 (SOCs) 中确定了32个首选术语 (PT) 信号,用于Ubrogepant诱导的不良事件.
- 已确认的已知不良事件,如偏头痛,恶心,昏昏欲睡,口腔麻醉和头.
- 检测到新的不良事件,包括半衰,精神障碍,失常,耳,胸痛,冷汗和部疼痛.
结论:
- 这项研究发现了与Ubrogepant相关的新的,以前未报告的不良事件.
- 这些发现为深入了解Ubrogepant的安全性提供了宝贵的指导.
- 为正在进行的对Ubrogepant长期安全性概况的评估做出贡献.
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