| アブストラクト | BACKGROUND: Proprotein convertase subtilisin/kexin type (PCSK9) inhibitor is a new drug class approved for treating dyslipidemias. Herein, we aimed to investigate the safety profiles of PCSK9 inhibitors (alirocumab and evolocumab) using the Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: We included adverse event (AE) reports regarding alirocumab and evolocumab submitted to the FAERs between 2015Q3 to 2021Q1. Disproportionality analyses, including reporting odds ratio (ROR), were performed to detect risk signals from the FAERs data to identify potential drug-AE associations. A signal was considered when the lower limit of the 95% confidence interval of ROR exceeded 1 and >/=3 AEs were reported. The definition relied on system organ class and preferred terms established by the Medical Dictionary for Regulatory Activities. RESULTS: The FAERS database documented 31 475 reports regarding PCSK9 inhibitors (alirocumab and evolocumab) from July 1, 2015, to March 31, 2021. Although some differences were detected, alirocumab and evolocumab shared considerably similar safety profiles. The most significant RORs and most common reports were injection-site reactions (eg, injection-site pain, bruising, haemorrhage, erythema), muscle-related AEs (eg, myalgia, back pain, arthralgia, muscle spasms), influenza-like illness, pain and headache. CONCLUSION: Data mining of the FAERs is useful for examining PCSK9 inhibitor-induced AEs. Herein, our findings were largely consistent with clinical experience and could help clinicians improve the safety of PCSK9 inhibitors in clinical practice. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2022/7/13 |
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| 投稿者 | Ji, Chunmei; Bai, Jinmei; Zhou, Jiancheng; Zou, Ying; Yu, Mingming |
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| 組織名 | Research Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing;Medical University, Nanjing, Jiangsu, China.;Department of Respiratory, Wuxi No.5 People's Hospital, Wuxi, Jiangsu, China.;Department of Urology, Shanghai Children's Hospital, Shanghai Jiao Tong;University, Shanghai, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35818959/ |
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