| アブストラクト | BACKGROUND: Our study aimed to identify inclisiran-related adverse events(AEs) for primary hypercholesterolemia and arteriosclerotic cardiovascular disease(ASCVD) from the US FDA Adverse Event Reporting System (FAERS) database, analyzing its links to AEs in the overall patient population and sex-specific subgroups to improve medication safety. METHODS: We analyzed inclisiran-related AEs signals by using statistical methods like Reporting Odds Ratio (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma-Poisson Shrinker (MGPS). RESULTS: Analyzing 2,400 AE reports with inclisiran as the primary suspected drug in the FAERS database, we identified 70 AE signals over 13 organ systems using the above four methods. Notable findings were strong signals for systemic diseases and various reactions at the site of administration (ROR 1.49, 95% CI 1.41-1.57), and various musculoskeletal and connective tissue diseases (ROR 4.07, 95% CI 3.83-4.03) in overall and gender-specific populations. Myalgia, a new ADE signal not in the drug insert, was a top signal by intensity and frequency (ROR 14.76, 95% CI 12.84-16.98). CONCLUSION: Our study revealed the strongest AE signals associated with inclisiran in both the overall population and gender subgroups, highlighting potential risks in clinical medication use and guiding balanced clinical decision-making. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/4/27 |
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| 投稿者 | He, YuBin; Guan, Xin; Zhang, YaYun; Zhu, Zixiong; Zhang, YanHui; Feng, Yue; Li, Xuewen |
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| 組織名 | Department of Cardiovascular Medicine, Third Hospital of Shanxi Medical;University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji;Shanxi Hospital, Taiyuan, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38676389/ |
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