| アブストラクト | BACKGROUND: Limited understanding 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 was performed by estimating the reported odds ratios (RORs), corroborated by 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 analyzes of rivaroxaban with dronedarone and diltiazem, and apixaban with losartan, telmisartan, and simvastatin. CONCLUSION: Our 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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