Li Chen, Lu Yicheng, Song Ziyue, Liu Yueqi
Department of Ophthalmology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Front Pharmacol. 2024 Jul 30;15:1398783. doi: 10.3389/fphar.2024.1398783. eCollection 2024.
Vascular endothelial growth factor (VEGF) is key to wet age-related macular degeneration (wAMD). Anti-VEGF drugs are the main treatment in clinics. This study assessed ocular adverse events (AE) from anti-VEGF drugs in VigiAccess, WHO's database, and compared adverse drug reaction (ADR) profiles of four drugs to aid personalized treatment choices for optimal benefit and safety.
The design was a descriptive retrospective study. We observed four anti-VEGF drugs commonly used in the clinical treatment of wAMD, and their ADR reports came from WHO-VigiAccess. The collected data included the age group, gender, and regional data, as well as the data of disease systems and symptoms caused by ADR recorded in the annual ADR reports and reports received by the WHO. We observed the overall characteristics of the ADR reports of these drugs, then explored the distribution of 27 SOCs of these drugs. Subsequently, we compared the most common ocular ADRs of the drugs. Finally, we compared the commonalities and differences of ocular ADRs related to the drugs.
Overall, 57,779 AE associated with the four anti-VEGF drugs were reported. The results showed that the number of females experiencing ADRs (67.83%) was significantly higher than males (32.17%), the age group with the highest reported incidence was over 75 years old. More than half of the ADR reports came from the Americas (50.86%). The five most common types of AE were: eye disorders (43.56%), general disorders and administration site conditions (34.47%), injury poisoning and procedural complications (13.36%), infections and infestations (11.61%), nervous system disorders (9.99%). Compared with the other three inhibitors, brolucizumab had a significantly higher rate of ocular ADR reports. The most common ocular ADRs of these four anti-VEGF drugs were mostly related to visual impairment, vision blurred, and blindness. However, there is still a disparity of ADRs between different drugs.
The presence of ocular AEs when using anti-VEGF drugs to treat wAMD in clinical practice should attract clinical attention. Clinicians should use these expensive drugs more rationally based on the characteristics of ADRs and develop personalized treatment plans for patients.
血管内皮生长因子（VEGF）是湿性年龄相关性黄斑变性（wAMD）的关键因素。抗VEGF药物是临床上的主要治疗手段。本研究在世界卫生组织的VigiAccess数据库中评估了抗VEGF药物的眼部不良事件（AE），并比较了四种药物的药物不良反应（ADR）特征，以帮助做出个性化的治疗选择，实现最佳疗效和安全性。
本研究为描述性回顾性研究。我们观察了临床治疗wAMD常用的四种抗VEGF药物，其ADR报告来自世界卫生组织VigiAccess。收集的数据包括年龄组、性别、地区数据，以及年度ADR报告和世界卫生组织收到的报告中记录的由ADR引起的疾病系统和症状数据。我们观察了这些药物ADR报告的总体特征，然后探究了这些药物27个系统器官分类（SOC）的分布情况。随后，我们比较了这些药物最常见的眼部ADR。最后，我们比较了与这些药物相关的眼部ADR的异同。
总体而言，共报告了57779例与四种抗VEGF药物相关的AE。结果显示，发生ADR的女性数量（67.83%）显著高于男性（32.17%），报告发病率最高的年龄组为75岁以上。超过一半的ADR报告来自美洲（50.86%）。五种最常见的AE类型为：眼部疾病（43.56%）、全身性疾病和给药部位情况（34.47%）、损伤中毒和操作并发症（13.36%）、感染和寄生虫感染（11.61%）、神经系统疾病（9.99%）。与其他三种抑制剂相比，布罗珠单抗的眼部ADR报告率显著更高。这四种抗VEGF药物最常见的眼部ADR大多与视力损害、视力模糊和失明有关。然而，不同药物之间的ADR仍存在差异。
临床实践中使用抗VEGF药物治疗wAMD时出现的眼部AE应引起临床关注。临床医生应根据ADR特征更合理地使用这些昂贵药物，并为患者制定个性化的治疗方案。
