Analyzing adverse event signals of aprepitant using FAERS database data in real-world settings: Broadening the adverse event spectrum of aprepitant and its clinical implications.

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Analyzing adverse event signals of aprepitant using FAERS database data in real-world settings: Broadening the adverse event spectrum of aprepitant and its clinical implications.

Analyzing adverse event signals of aprepitant using FAERS database data in real-world settings: Broadening the adverse event spectrum of aprepitant and its clinical implications.

アブストラクト	Aprepitant, a neurokinin-1 receptor antagonist approved by the US FDA for chemotherapy- and postoperative-induced nausea and vomiting, has limited real-world safety data; we therefore interrogated the FDA Adverse Event Reporting System from Q1 2004 to Q3 2023 to systematically characterize aprepitant-associated adverse drug events. After extracting 8271 reports on 3033 patients, we applied a combined signal detection framework - reporting odds ratio, proportional reporting ratio and the Bayesian confidence propagation neural network with multi-item gamma Poisson shrinker - and analyzed demographics, reporter profiles and temporal trends. Women represented 54.10% of cases, the 45 to 65-year age group 27.86%, and healthcare professionals filed 65.64% of reports; the United States, France, Japan, the United Kingdom, and China contributed most cases, peaking during 2013 to 2019. While labeled toxicities were confirmed, novel high-strength signals emerged, including joint deposition, oral mucosal roughening, encephalopathy, dysplasia, febrile myelodysplasia, small cell lung cancer and tonic-clonic movements, whereas dyspnea and nausea remained the 2 most frequently reported events. These findings corroborate known risks and unveil previously under-recognized aprepitant related adverse reactions, providing actionable safety guidance for clinicians and suggesting that the strong joint deposition signal warrants prospective investigation of aprepitant in arthritic disorders.
ジャーナル名	Medicine
Pubmed追加日	2025/12/10
投稿者	Chen, Feichi; Cai, Di; Wen, Heli; Zhang, Liang
組織名	Department of Neurology, The First Affiliated Hospital of Wenzhou Medical;University, Wenzhou, Zhejiang, China.;Department of General Practice, Huazhong Agricultural University Hospital, Wuhan,;Hubei, China.;Department of Gastroenterology, The First Affiliated Hospital of Wenzhou Medical;Department of Breast Surgery, Hubei Cancer Hospital, Tongji Medical College,;Huazhong University of Science and Technology, Hubei Provincial Clinical Research;Center for Breast Cancer, Wuhan Clinical Research Center for Breast Cancer,;Wuhan, Hubei, China.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/41366886/