PDE5抑制剂与动脉瘤/动脉解剖之间的关联:使用世卫组织安全数据库进行的一项药监测研究
Koji Miyata1, Yuki Izawa-Ishizawa1,2, Takahiro Niimura1,3
1Department of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.
The journal of medical investigation : JMI
|May 12, 2024
概括
固酶5型 (PDE5) 抑制剂可能会增加严重动脉疾病的风险,如动脉瘤和解剖. 对现实世界的数据的分析表明,PDE5抑制剂使用与危险的动脉事件之间存在潜在的联系.
科学领域:
- 药物监督 药物监督 药物监督
- 心血管研究研究心血管研究
- 药品安全 药品安全
背景情况:
- 动脉瘤和动脉解剖是已知的与某些药物相关的不良药物事件.
- 最近的报道表明,代酶5型 (PDE5) 抑制剂和严重的动脉疾病之间存在潜在的关联.
- 关于PDE5抑制剂对严重心血管不良事件的安全性概况需要进一步调查.
研究的目的:
- 评估PDE5抑制剂使用与动脉瘤和动脉解剖发生之间的关联.
- 为了产生关于与PDE5抑制剂相关的严重不良事件的潜在风险的假设.
主要方法:
- 利用VigiBase,这是世界卫生组织自发报告的不良事件的全球数据库.
- 对1967年至2022年12月的数据进行了不成比例分析.
- 计算报告几率比率 (ROR) 来评估PDE5抑制剂与动脉疾病之间的关联.
主要成果:
- 对195,839份PDE5抑制剂报告的分析发现了254例动脉疾病.
- 对PDE5抑制剂观察到显著的不成比例信号 (ROR,2.30;95% CI,2.04-2.61).
- 当专注于大动脉或脑动脉病变时,信号仍然存在,并且在两性中都注意到了这一点.
结论:
- 现实世界的数据分析表明,PDE5抑制剂在严重动脉疾病的发展中可能发挥作用.
- PDE5 抑制剂可能与潜在致命性动脉事件的风险增加有关.
- 需要进一步的研究来证实这些发现,并阐明潜在的机制.
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