| アブストラクト | AIMS: Protein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are novel lipid-lowering agents used in patients with cardiovascular disease. Despite reassuring safety data from pivotal trials, increasing evidence from real-world studies suggests that PCSK9i increase the risk of bacterial and viral infections. Therefore, this study aimed to identify signals of infection-related adverse events (AEs) associated with PCSK9i. METHODS: We performed an observational pharmacovigilance study using the World Health Organization's VigiBase, recorded up to December 2022. We included individual case safety reports (ICSRs) of PCSK9 inhibitors, alirocumab and evolocumab, and compared them with those of other drugs. Infection-related ICSRs were retrieved from the Medical Dictionary for Regulatory Activities System Organ Class 'infections and infestations.' RESULTS: Among 114,293 reports (258,099 drug-AE pairs) related to PCSK9 inhibitors, 54% included female patients, 41% included patients aged >/=65 years, and 82% included patients who received evolocumab. Additionally, beyond AEs recognized by regulatory authorities, organ infections such as influenza (reporting odds ratio [ROR] 2.89, 95% confidence interval [CI] 2.74-3.05), gastric infections (ROR 2.47, 95% CI 1.63-3.75), and kidney infections (ROR 1.36, 95% CI 1.06-1.73) were observed. Sensitivity analysis indicated a heightened risk of infection-related AEs associated with PCSK9i regardless of the specific drug type. CONCLUSIONS: In addition to the labelled respiratory infections, six infection-related symptoms in the gastrointestinal, urinary, and renal organs were identified. Our findings support the need for systematic surveillance of infections among PCSK9i users. |
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| ジャーナル名 | Drugs - real world outcomes |
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| 投稿日 | 2024/7/2 |
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| 投稿者 | Park, Dahyun; Bea, Sungho; Bae, Ji-Hwan; Lee, Hyesung; Choe, Young June; Shin, Ju-Young; Kim, Hoon |
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| 組織名 | Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South;Korea.;School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon,;Gyeonggi-do, South Korea.;Department of Paediatrics, Korea University Anam Hospital, Seoul, South Korea.;Korea. shin.jy@skku.edu.;Gyeonggi-do, South Korea. shin.jy@skku.edu.;Department of Clinical Research Design and Evaluation, Samsung Advanced Institute;for Health Sciences and Technology, Sungkyunkwan University, Seoul, South Korea.;shin.jy@skku.edu.;Korea. wisekh@skku.edu.;Gyeonggi-do, South Korea. wisekh@skku.edu. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38954190/ |
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