Analysis of hemorrhagic drug-drug interactions between P-gp inhibitors and direct oral anticoagulants from the FDA Adverse Event Reporting System.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-07-08 DOI:10.1080/14740338.2024.2376693
Mengyao Li, Jian Xiao, Ting Yu, Ling Huang, Ruwen Cai, Huimin Yu, Jingyang Li, Shuqiao Cheng
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Abstract

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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从 FDA 不良事件报告系统中分析 P-gp 抑制剂和直接口服抗凝剂之间的出血性药物相互作用。
背景:关于P-糖蛋白(P-gp)抑制剂和直接口服抗凝剂(DOACs)之间潜在的相互作用所导致的出血风险,目前所知有限。我们利用食品药品管理局不良事件报告系统(FAERS)的数据,分析了与 P-gp 抑制剂和 DOACs 联合用药相关的出血不良事件(AEs),旨在为其安全合理使用提供指导。通过估算报告的几率比(ROR)进行出血信号挖掘分析,并使用加法和乘法模型以及组合风险比(PRR)模型进一步确认分析结果:我们的分析涵盖 4,417,195 个病例,发现 11,967 例出血事件与 P-gp 抑制剂有关。我们观察到阿哌沙班和非洛地平联合用药的出血风险明显更高(ROR 118.84,95% CI 78.12-180.79,加法模型 0.545,乘法模型 1.253,PRR 22.896(2450.141))。此外,在利伐沙班与决奈达隆和地尔硫卓以及阿哌沙班与洛沙坦、替米沙坦和辛伐他汀的联合用药分析中也发现了一致的关联:我们对 FAERS 数据的分析揭示了与 P-gp 抑制剂和 DOACs 联合用药相关的不同程度的出血风险,强调了在临床实践中对它们保持警惕的重要性。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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