Thromboembolism adverse event profiles of thrombopoietin receptor agonists: a real-world, pharmacovigilance study.

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2024-10-16 DOI:10.1080/14740338.2024.2416540

Xintian Xu, Lingxiao Zhang, Xiaoyu Zhang, Wanjing Huang, Longgui Xie, Mao Ouyang

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引用次数: 0

Abstract

Background: Thrombopoietin receptor agonists (TPO-RAs) are currently approved for the treatment of thrombocytopenia in different conditions. The relationship between TPO-RAs and thromboembolic events (TEEs) remains controversial.

Research design and methods: We extracted TPO-RAs adverse reaction reports after their marketing until now, using the FDA adverse event reporting system (FAERS). Positive signals were detected by reporting odds ratios (RORs). And the Weibull shape parameter test was utilized to analyze the time-to-onset profiles.

Result: Thromboembolic events accounted for 8.97% among TPO-RAs reports. Increased reporting of TEEs was related to TPO-RAs treatment compared with the entire FAERS database [ROR = 2.65 (2.56, 2.73)]. In addition, venous thrombotic events [ROR = 4.13 (3.92, 4.35)] were reported more frequently than arterial events ROR = 1.81 (1.7, 1.93)]. Age over 60 years [odds ratio (OR) = 1.10 (1.01, 1.20), p = 0.029] and weight over 80 kg [OR = 1.36 (1.17, 1.58), p < 0.001] of patients might have higher risk of TEEs during TPO-RAs therapy.

Conclusion: Evidence from the real world suggested that TPO-RAs were associated with higher incidence of TEEs, particularly venous thrombosis. The risk of TPO-RAs-associated TEEs mostly happened in the early stages of treatment and decreased over time.

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血小板生成素受体激动剂的血栓栓塞不良事件概况：一项真实世界的药物警戒研究。

背景：血小板生成素受体激动剂（TPO-RAs）目前已被批准用于治疗不同情况下的血小板减少症。TPO-RAs与血栓栓塞事件（TEEs）之间的关系仍存在争议：我们利用美国食品药品管理局不良事件报告系统（FAERS）提取了 TPO-RAs 上市后至今的不良反应报告。通过报告几率比（ROR）检测阳性信号。并利用Weibull形状参数检验分析发病时间曲线：结果：血栓栓塞事件占 TPO-RAs 报告的 8.97%。与整个FAERS数据库相比，TEE报告的增加与TPO-RAs治疗有关[ROR = 2.65 (2.56, 2.73)]。此外，静脉血栓事件 [ROR = 4.13 (3.92, 4.35)]的报告频率高于动脉血栓事件 [ROR = 1.81 (1.7, 1.93)]。年龄超过 60 岁 [比值比 (OR) = 1.10 (1.01, 1.20)，P = 0.029] 和体重超过 80 公斤 [OR = 1.36 (1.17, 1.58)，P 结论：来自真实世界的证据表明，TPO-RAs 与较高的 TEE 发生率有关，尤其是静脉血栓。与 TPO-RAs 相关的 TEE 风险大多发生在治疗的早期阶段，并随着时间的推移而降低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

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.