BackgroundPharmacological inhibition of angiogenesis via the vascular endothelial growth factor pathway is an important therapeutic target that prevents tumor growth and the formation of metastases. Although vascular endothelial growth factor inhibitor (VPI) is well understood as a well‐defined safety profile, few real‐world studies are comparing the incidence, clinical features, and prognosis of the aneurysm and artery dissection.Methods and ResultsTo evaluate and compare the links between different VPIs and aneurysm and artery dissection, we identified 634 reports with VPIs in the US Food and Drug Administration Adverse Event Reporting System database ranging between January 2004 to March 2020. We used the reporting odds ratio for the association between the use of VPIs and aneurysm and artery dissection. The reporting odds ratio (3.68, 95%, 2.18‒6.23) shows that ramucirumab has a stronger correlation than other VPIs. The results show a significant difference in onset time (P<0.001). The median time to aneurysm and artery dissection was 79.5 (interquartile interval, 19.0–273.5) days after VPI administration. The results also show that VPI‐associated aneurysm and artery dissection was reported more often in men (n=336, 59.68% versus n=227, 40.32%), and there were more cases in patients aged between 45 to 74 years than those <45 years (n=312, 68.12% versus n=18, 3.93%); patients aged ≥75 years accounted for 27.95% (n=128). Finally, the suspected drugs generally led to 19.98% deaths and 29.81% hospitalizations.ConclusionsWe identified signals for aneurysm and artery dissection following various VPIs in real‐world practice via the Food and Drug Administration Adverse Event Reporting System, which represents the first step for continued pharmacovigilance investigation.

中文翻译：

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使用血管内皮生长因子抑制剂后的动脉瘤和动脉夹层：使用自发报告系统进行的真实世界分析


背景通过血管内皮生长因子途径对血管生成的药理学抑制是防止肿瘤生长和转移形成的重要治疗靶点。尽管血管内皮生长因子抑制剂 (VPI) 被广泛认为是一种明确的安全性，但很少有现实世界的研究比较动脉瘤和动脉夹层的发生率、临床特征和预后。方法和结果评估和比较这些链接在不同 VPI 与动脉瘤和动脉夹层之间的比较中，我们在美国食品和药物管理局不良事件报告系统数据库中确定了 2004 年 1 月至 2020 年 3 月期间 634 份有关 VPI 的报告。动脉瘤和动脉夹层。报告优势比（3.68、95%、2.18-6.23）表明雷莫芦单抗比其他 VPI 具有更强的相关性。结果显示起效时间存在显着差异（ P <0.001）。 VPI 给药后，发生动脉瘤和动脉夹层的中位时间为 79.5 天（四分位间距，19.0-273.5）天。结果还显示，与 VPI 相关的动脉瘤和动脉夹层在男性中更常见（n=336，59.68% vs n=227，40.32%），并且年龄在 45 至 74 岁之间的患者中的病例多于 % 3C45 年（n=312，68.12% 对比 n=18，3.93%）；年龄≥75岁的患者占27.95%（n=128）。最后，可疑药物普遍导致19.98%的死亡和29.81%的住院治疗。结论我们通过食品和药物管理局不良事件报告系统在现实世界实践中识别出各种 VPI 后的动脉瘤和动脉夹层信号，这是持续药物警戒调查的第一步。