Li Jing, Gong Junjie, Liu Ziyu, Liu Yuheng, He Anqi, Wang Zengguang
Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.
Key Laboratory of Post- Neuroinjury Neuro-Repair and Regeneration in Central Nervous System, Tianjin Neurological Institute, Ministry of Education and Tianjin, Tianjin, China.
Endocr Metab Immune Disord Drug Targets. 2025;25(9):746-756. doi: 10.2174/0118715303324204240905111835.
The purpose of this study was to comprehensively evaluate the association of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) with neurological adverse events using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, with the aim of guiding the rational use of statins.
The number and clinical characteristics of adverse events (AEs) to statins in the FAERS database between 2012 and March, 2023, were extracted. Neurological AEs were defined by the system organ classes (SOCs) of "Nervous System Disorders (10029205)" and the corresponding PT. Disproportionality was calculated using the reporting dominance ratio (ROR), proportional reporting ratio (PRR), and information component (IC).
Between January, 2012 and March, 2023, a total of 90,357 AEs were reported for the three statins (atorvastatin, resuvastatin, and simvastatin). The majority of reports on AEs came from the United States (n = 7284). A total of 8409 reports described neurological AEs following the use of the three statins, with atorvastatin accounting for more than half of the reports (n = 4430). The mean age of patients who developed neurological AEs was 55 years and older. The prevalence was similar in female patients (2230/4480) and male patients (1999/4480). Disproportionate analyses showed that at the SOC level, only the correlation between atorvastatin and neurological AEs suggested a positive signal (ROR: 9.77 (9.56-9.99); IC: 3.28; PRR (χ): 9.76 (16.07)) and in total, there were 32 PTs with a positive signal. The median time for neurological AEs was 71 days (IQR: 14-559 days), and the most common AEs were other serious effects (important medical event) (OT) (n = 2283) and hospitalization (HO) (n = 715).
This study suggests that atorvastatin may be associated with an increased risk of neurological AEs. This study provides realistic evidence of the potential risk of statin-related adverse events.
本研究旨在利用美国食品药品监督管理局不良事件报告系统（FAERS）数据库，全面评估3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂（他汀类药物）与神经系统不良事件之间的关联，以指导他汀类药物的合理使用。
提取2012年至2023年3月期间FAERS数据库中他汀类药物不良事件（AE）的数量及临床特征。神经系统不良事件由“神经系统疾病（10029205）”的系统器官分类（SOC）及相应的首选术语（PT）定义。使用报告优势比（ROR）、比例报告比（PRR）和信息成分（IC）计算不成比例性。
2012年1月至2023年3月期间，三种他汀类药物（阿托伐他汀、瑞舒伐他汀和辛伐他汀）共报告了90357例不良事件。不良事件的大多数报告来自美国（n = 7284）。共有8409份报告描述了使用这三种他汀类药物后的神经系统不良事件，其中阿托伐他汀的报告占一半以上（n = 4430）。发生神经系统不良事件的患者平均年龄在55岁及以上。女性患者（2230/4480）和男性患者（1999/4480）的患病率相似。不成比例分析显示，在SOC水平上，仅阿托伐他汀与神经系统不良事件之间的相关性显示出阳性信号（ROR：9.77（9.56 - 9.99）；IC：3.28；PRR（χ）：9.76（16.07）），总体上有32个PT显示出阳性信号。神经系统不良事件的中位时间为71天（四分位间距：14 - 559天），最常见的不良事件是其他严重影响（重要医疗事件）（OT）（n = 2283）和住院（HO）（n = 715）。
本研究表明阿托伐他汀可能与神经系统不良事件风险增加有关。本研究为他汀类药物相关不良事件的潜在风险提供了实际证据。
