标签变化的影响 (盒子警告) 对于在痛风患者中使用febuxostat的现实世界:一项跨部门药物使用研究
Alexandra Z Sosinsky1, Yufei Song1, Lhanoo Gunawardhana2
1Epidemiology and Drug Safety, Real World Evidence Solutions, IQVIA, Cambridge, MA, USA.
Rheumatology and therapy
|July 17, 2023
概括
在2019年标签更改后,痛风患者在现实世界中使用febuxostat减少了. 这项研究分析了新的和流行的febuxostat用户,并指出使用量下降后标签更新.
科学领域:
- 药理学 药理学是指药理学的学科.
- 痛风管理 痛风管理
- 评估心血管风险评估
背景情况:
- 2019年对febuxostat的标签更改促使对其现实世界药物使用情况进行评估.
- 了解febuxostat对痛风和心血管疾病 (CVD) 患者的影响至关重要.
研究的目的:
- 评估2019年标签变更对痛风患者使用febuxostat的影响.
- 分析新发病者与流行发病者,以及已确诊心血管疾病的发病者.
主要方法:
- 使用美国行政索赔数据 (IQVIA PharMetrics Plus,Optum研究数据库) 的描述性,非干预性,横截面研究.
- 包括从2016年6月1日开始使用febuxostat的痛风患者.
- 收集有关吸毒,心血管疾病,并发症和人口统计的数据.
主要成果:
- 在两个数据库中,febuxostat的使用率和新用户的比例都下降了.
- 在PharMetrics Plus中,42.7%是新用户;在ORD中,40.5%是新用户.
- 常见的CVD发病率包括糖尿病,缺血性心脏病和心力衰竭.
结论:
- 在2019年标签更改后,现实世界的febuxostat利用率下降.
- 据推测,观察到的下降是对更新的安全信息的反应.
- 尽管如此,Febuxostat的益处风险概况仍然有利于选择的痛风患者.
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