| アブストラクト | BACKGROUND: This study analyzed adverse events (AE) associated with inclisiran using the FDA's Adverse Event Reporting System (FAERS) to detect and characterize relevant safety signals. METHODS: 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. RESULTS: A total of 4,122 reports of inclisiran as the 'primary suspected.' Compared with all other drugs, the most significant system organ classe (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). And these two SOCs were more strongly with inclisiran than evolocumab. At the preferred term (PT) level, strong signals were detected for cellulitis gangrenous (ROR 101.29, PRR 101.27, IC 6.54, EBGM 92.91), 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). CONCLUSIONS: This study enhances our understanding of AEs to inclisiran. Future research on its long-term real-world use will offer further insights into its safety. |
|---|
| ジャーナル名 | Expert opinion on drug safety |
|---|
| 投稿日 | 2024/9/26 |
|---|
| 投稿者 | Shi, Xuezhong; Qiao, Ying; Yang, Yongli; Wang, Nana; Zhang, Yi; Shi, Shangxin; Shen, Guibin; Jia, Xiaocan |
|---|
| 組織名 | Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou;University, Zhengzhou, China. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39323041/ |
|---|
