Shi Xuezhong, Qiao Ying, Yang Yongli, Wang Nana, Zhang Yi, Shi Shangxin, Shen Guibin, Jia Xiaocan
Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, China.
Expert Opin Drug Saf. 2024 Sep 30:1-6. doi: 10.1080/14740338.2024.2409707.
This study analyzed adverse events (AEs) associated with inclisiran using the FDA's Adverse Event Reporting System (FAERS) to detect and characterize relevant safety signals.
We retrospectively extracted AE reports from the FAERS database spanning Q1 2022 to Q2 2024. Four disproportionality analysis algorithms were employed to identify AE signals for inclisiran, with subsequent comparisons made to PCSK9 monoclonal antibodies (alirocumab/evolocumab). Additionally, we examined the characteristics and onset timing of inclisiran-related AE.
A total of 4,122 reports of inclisiran as the 'primary suspected'. Compared with all other drugs, the most significant system organ class (SOC) was 'musculoskeletal and connective tissue disorders' (ROR = 3.64, PRR = 3.19) and the most common SOC was 'general disorders and administration site conditions' (n = 2,769). These two SOCs were more strongly with inclisiran than evolocumab. At the preferred term level, strong signals were detected for cellulitis gangrenous (ROR = 101.29, PRR = 101.27, IC = 6.54, EBGM = 92.91) and bladder discomfort (ROR = 12.61, PRR = 12.61, IC = 3.64, EBGM = 12.48). The median onset time for inclisiran-related AEs was 43 days (interquartile range: 7-99 days).
This study enhanced our understanding of AEs to inclisiran. Future research on its long-term real-world use will offer insights into its safety.
本研究使用美国食品药品监督管理局不良事件报告系统（FAERS）分析与英克西兰相关的不良事件（AE），以检测并描述相关的安全信号。
我们回顾性地从FAERS数据库中提取了2022年第一季度至2024年第二季度的AE报告。采用四种不成比例分析算法来识别英克西兰的AE信号，随后与PCSK9单克隆抗体（阿利西尤单抗/依洛尤单抗）进行比较。此外，我们还研究了与英克西兰相关的AE的特征和发病时间。
共有4122份报告将英克西兰列为“主要怀疑药物”。与所有其他药物相比，最显著的系统器官类别（SOC）是“肌肉骨骼和结缔组织疾病”（报告比值比[ROR]=3.64，比例报告比值[PRR]=3.19），最常见的SOC是“全身疾病和给药部位状况”（n=2769）。这两个SOC与英克西兰的关联比与依洛尤单抗的更强。在首选术语层面，检测到蜂窝织炎坏疽（ROR=101.29，PRR=101.27，信息系数[IC]=6.54，经验贝叶斯几何均值[EBGM]=92.91）和膀胱不适（ROR=12.61，PRR=12.61，IC=3.64，EBGM=12.48）的强信号。与英克西兰相关的AE的中位发病时间为43天（四分位间距：7-99天）。
本研究增进了我们对英克西兰AE的理解。对其长期实际应用的未来研究将为其安全性提供见解。
