| アブストラクト | BACKGROUND: Limited data have raised concerns about an increased risk of thromboembolic adverse events in atrial fibrillation (AF) patients co-treated with factor Xa-inhibiting direct oral anticoagulants (FXa-DOACs) and anti-seizure medications (ASMs). However, evidence regarding this association remains controversial. OBJECTIVES: This study aims to investigate the impact of ASMs on the reporting of thromboembolic events in FXa-DOAC-treated patients. METHODS: This study analyzed data from the FDA Adverse Event Reporting System (FAERS) between 2011Q3 and 2024Q1 using the weighted composite score integrated by four pharmacovigilance signals [reporting odds ratio (ROR), Empirical Bayes Geometric Mean (EBGM), additive model and multiplicative model]. RESULTS: A total of 177 cases of thromboembolic events were identified in patients using combined FXa-DOACs and ASMs. Levetiracetam together with FXa-DOACs was associated with an increased risk of thromboembolic events, particularly apixaban (ROR: 2.29, 95%CI 1.56-3.38; EBGM05:1.32; additive model:0.14 > 0; multiplicative mode: 2.47 > 1;composite score:1) and rivaroxaban (ROR:3.81, 95% CI 2.77-5.26; EBGM05:1.99; additive model:0.13; multiplicative model:1.71; composite score:1). Valproic acid was associated with thromboembolic risk when with rivaroxaban (ROR:4.80, 95%CI 2.50-9.19; EBGM05:1.64; additive model:0.29; multiplicative model:8.48; composite score:1). CONCLUSION: This study suggests that the concomitant use of levetiracetam and valproic acid with FXa-DOACs is associated with an increased risk of thromboembolic events. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/4/30 |
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| 投稿者 | Ding, Lingqing; Chen, Congqin; Yang, Yongkuan; Xiao, Jie |
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| 組織名 | Department of Pharmacy, Xiamen Cardiovascular Hospital, Xiamen University,;Xiamen, China.;School of Electrical Engineering and Automation, Xiamen University of Technology, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40302219/ |
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