来自 FAERS 数据库的利眠宁实际不良事件研究。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-23 DOI:10.1080/14740338.2024.2418319
Hong Pan, Shasha Lin
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引用次数: 0

摘要

研究背景本研究的主要目的是利用美国食品和药物管理局不良事件报告系统(FAERS)资料库对利美昔康(rimegepant)进行详尽评估:本研究下载了2020年第二季度至2024年第一季度与rimegepant相关的报告文件。结果:本研究分析了 6659 例药物不良事件(ADEs):本研究分析了 6659 份与利美喷作为主要可疑 (PS) 药物相关的 ADE 报告。在对系统器官类别(SOCs)的不成比例分析中,利美喷剂的重要信号是一般疾病和用药部位条件。信号强度较高的前 5 个 ADE 为药物过度使用性头痛、鼻水肿、紧张性头痛、工作状态下降和晕车。最常见的 ADE 为恶心、感觉异常、上腹部疼痛、嗜睡和过敏。此外,我们还需要注意说明书中未提及但具有临床意义的 ADE:眩晕、听觉异常、嗜睡、雷诺现象、晕车、惊恐发作和恐惧:本研究强调了以前未认识到的与使用利美喷相关的安全问题。这些新的安全问题表明,虽然这些治疗方法可能有效,但可能还需要进一步探讨其他风险。
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A real-world adverse events study of rimegepant from the FAERS database.

Background: The primary objective of this research is to conduct an exhaustive evaluation of rimegepant with the Food and Drug Administration Adverse Event Reporting System (FAERS) repository.

Research design and methods: This study downloaded the reporting files related to rimegepant from the second quarter of 2020 to the first quarter of 2024. Disproportionality analysis was utilized to explore the relationship between rimegepant and adverse drug events (ADEs).

Results: This study analyzed 6659 ADE reports associated with rimegepant as the primary suspected (PS) drug. In the disproportionate analysis of system organ classes (SOCs), the significant signal for rimegepant was general disorders and administration site conditions.On the preferred terms level, 35 ADEs were identified following the exclusion. The top five ADEs with high signal strengths were medication overuse headache, nasal edema, tension headache, performance status decreased, and motion sickness. The most frequent ADEs were nausea, feeling abnormal, abdominal pain upper, somnolence, and hypersensitivity. In addition, we need to pay attention to the ADEs not mentioned in the instruction and clinically significant: vertigo, hyperacusis, somnolence, Raynaud's phenomenon, motion sickness, panic attack, and fear.

Conclusions: This study highlights previously unrecognized safety concerns associated with the use of rimegepant. These novel safety aspects suggest that while these treatments can be effective, additional risks may need further exploration.

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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.
期刊最新文献
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