与丁诺苏玛布相关的低血事件:来自FDA不良事件报告系统 (FAERS) 数据库的现实研究
Siyuan Gao1, Guanhao Zheng2, Zhichao He3
1Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangzhou, China.
Therapeutic innovation & regulatory science
|October 25, 2024
概括
用于骨质疏松症和癌症的德诺苏马布与显著的低热血症风险有关,这是一个严重的不良事件. 这项研究证实了在现实世界的数据中使用登苏马布的低血症的强有力的安全信号.
科学领域:
- 药监和药物安全 药监和药物安全
- 临床药理学 临床药理学
- 骨代谢和瘤学 骨代谢和瘤学
背景情况:
- 德诺苏马布是骨质疏松症和各种癌症的关键治疗剂.
- 低血是经常观察到的与登苏马布治疗相关的不良事件.
- 现实世界的数据分析对于理解药物安全性概况至关重要.
研究的目的:
- 调查与denosumab相关的低血症不良事件的发生率和特征.
- 通过使用来自FDA不良事件报告系统 (FAERS) 的现实数据,评估denosumab诱导的低血症的安全信号.
- 为了比较denosumab与双酸盐的低血症风险.
主要方法:
- 利用了FAERS数据库中的数据,涵盖2017年1月1日至2021年12月31日的时间.
- 仅包括疑似低血症作为denosumab的不良事件的病例.
- 采用药监方法,包括报告几率比率 (ROR),以评估安全信号.
主要成果:
- 在102,413份denosumab报告中,确定了1042例与denosumab相关的低血症.
- 患者的中位年龄为70岁,大多数是男性;中位发病时间为23天.
- 德诺苏马布在低血症方面显示出显著的安全信号 (ROR=14.09),特别是在癌症患者中 (ROR=21.28) 和与双酸盐 (ROR=1.88) 相比.
结论:
- 德诺苏马布与低热血症的实质性安全信号有关.
- 在接受denosumab治疗的癌症患者中,低血症的风险显著增加.
- 这些发现强调了在denosumab治疗期间监测水平的重要性.
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