| アブストラクト | Background Pharmacological 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 Results To 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 E.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. Conclusions We 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. |
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| ジャーナル名 | Journal of the American Heart Association |
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| Pubmed追加日 | 2021/12/1 |
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| 投稿者 | Wang, Shuyue; Chen, Mingzhu; Zhang, Xinghui; Zhang, Lingjian; Jia, Min; Shen, Zhiwen; Wang, Junyan; Zhao, Bin; Gong, Yang; Gong, Jian |
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| 組織名 | Research Group of Jian Gong on Pharmacoepidemiology and Clinical Drug Evaluation;Shenyang Pharmaceutical University Shenyang China.;Department of Pharmacy Heping Campus of General Hospital of the Northern War Zone;of the Chinese People's Liberation Army China Medical University Shenyang China.;Department of Pharmacy Peking Union Medical College Hospital Beijing China.;School of Biomedical Informatics University of Texas Health Science Center at;Houston Houston TX. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34845918/ |
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