使用伐尼克兰溶液与眼部不良事件的关联:一项基于人群的研究。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-08 DOI:10.1080/14740338.2025.2460454
Moiz Lakhani, Angela T H Kwan, Anne Xuan-Lan Nguyen, Marko M Popovic, Roger S McIntyre, Albert Y Wu
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引用次数: 0

摘要

背景:varenicline溶液于2021年获得FDA批准,是首款专门设计用于增强基底泪膜生成以治疗干眼病(DED)的鼻喷雾剂。然而,缺乏将其安全性与传统DED疗法进行全面比较的数据。在此,我们评估是否眼部不良事件(ae)是不成比例的报告与实际使用伐尼克兰溶液。研究设计和方法:这项观察性的、基于人群的药物警戒研究使用报告优势比(ROR)分析了美国食品和药物管理局不良事件报告系统(FAERS)的数据(开始- 2024年4月),显著性定义为95% CI下限bbb1.0。鼻盐水和系统坦作为对照。结果:与伐尼克兰溶液相关的AE报告共1125例。在比较伐尼克兰溶液和鼻盐水时,没有观察到不相称的特异性眼部不良反应报告。然而,与系统坦相比,伐尼克兰溶液显示出更高的流泪几率(ROR = 2.18, 95%CI = 1.46-3.26, p = 0.0085)和畏光几率(ROR = 7.50, 95%CI = 3.68-15.27, p)。结论:尽管与系统坦相比,伐尼克兰溶液更高的ROR不能建立直接的因果关系,但我们的研究结果为潜在的风险信号提供了证据,并强调了上市后药物警戒在监测长期安全性方面的关键作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Association of ocular adverse events with varenicline solution use: a population-based study.

Background: Approved by the FDA in 2021, varenicline solution is the first nasal spray specifically designed to enhance basal tear film production for treating dry eye disease (DED). However, there is a lack of data comprehensively comparing its safety profile to conventional DED therapies. Herein, we assess whether ocular adverse events (AEs) are disproportionately reported with the real-world use of varenicline solution.

Research design and methods: This observational, population-based pharmacovigilance study analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) data (inception-April 2024) using reporting odds ratio (ROR), with significance defined as a 95% CI lower bound > 1.0. Nasal saline and systane were the controls.

Results: A total of 1,125 AE reports were associated with varenicline solution. No disproportionate reporting of specific ocular AEs was observed when comparing varenicline solution with nasal saline. However, when compared with systane, varenicline solution showed higher odds of lacrimation (ROR = 2.18, 95%CI = 1.46-3.26, p < 0.0001), visual impairment (ROR = 2.27, 95%CI = 1.24-4.16, p = 0.0085), and photophobia (ROR = 7.50, 95%CI = 3.68-15.27, p < 0.0001).

Conclusions: Although a direct causal relationship for higher RORs cannot be established for varenicline solution compared to systane, our findings provide evidence for potential risk signals and highlight the crucial role of post-marketing pharmacovigilance in monitoring long-term safety.

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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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