| アブストラクト | BACKGROUND: Limited knowledge exists regarding the hemorrhagic risk resulting from potential interactions between P-glycoprotein (P-gp) inhibitors and direct oral anticoagulants (DOACs). Utilizing the Food and Drug Administration Adverse Event Reporting System (FAERS) data, we analyzed hemorrhagic adverse events (AEs) linked with the co-administration of P-gp inhibitors and DOACs, aiming to offer guidance for their safe and rational use. METHODS: Hemorrhagic events associated with P-gp inhibitors in combination with DOACs were scrutinized from the FAERS database. Hemorrhagic signals mining analysis was performed by estimating the reported odds ratios (RORs) and further confirming the findings using additive and multiplicative models and a combination risk ratio (PRR) model. RESULTS: Our analysis covered 4,417,195 cases, revealing 11,967 bleeding events associated with P-gp inhibitors. We observed a significantly higher risk of bleeding with the combination of apixaban and felodipine (ROR 118.84, 95% CI 78.12-180.79, additive model 0.545, multiplicative model 1.253, PRR 22.896(2450.141)). Moreover, consistent associations were found in the co-administration analyses of rivaroxaban with dronedarone and diltiazem, and apixaban with losartan, telmisartan, and simvastatin. CONCLUSION: Our analysis of FAERS data analysis unveils varying degrees of bleeding risk associated with the co-administration of P-gp inhibitors and DOACs, underscoring the importance of vigilance about them in clinical practice. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/7/4 |
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| 投稿者 | Li, Mengyao; Xiao, Jian; Yu, Ting; Huang, Ling; Cai, Ruwen; Yu, Huimin; Li, Jingyang; Cheng, Shuqiao |
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| 組織名 | College of Pharmacy, Dali University, Dali, Yunnan, China.;Department of Pharmacy, Xiangya Hospital, Central South University, Changsha,;Hunan, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38962834/ |
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