| アブストラクト | BACKGROUND: Evolocumab is a humanized immunoglobulin G2 monoclonal antibody, directed against Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), prescribed in hypercholesterolemic patients. The safety profile of this drug is currently defined by the data of pre-authorization clinical trials. The purpose of this study is to update knowledge of the safety of evolocumab through an analysis of post-marketing real-world data on suspected adverse reactions (SARs), reported by the EudraVigilance database system. METHODS: The public version of the EudraVigilance database has been used, and only serious SARs signals were included. RESULTS: Musculoskeletal system disorders, flu-like symptoms, injection-site reactions, skin reactions, and metabolism and nutrition disorders are observed in the post-marketing surveillance, as well as being found in the pre-authorization studies. Not previously signaled in the pre-marketing studies, diarrhea was reported. Furthermore, signals related to cardiac adverse reactions, more frequently at the expense of adults in comparison to elders, were found. CONCLUSIONS: The post-marketing safety profile of evolocumab emerging from an analysis of the EudraVigilance data system indicates it is sufficiently safe but suggests the necessity for caution when it is prescribed to hyperlipidemic patients affected by heart diseases. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2024/3/28 |
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| 投稿者 | Calapai, Fabrizio; Mannucci, Carmen; Curro, Mariaconcetta; Cardia, Luigi; Esposito, Emanuela; Calapai, Gioacchino; Ammendolia, Ilaria |
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| 組織名 | Department of Clinical and Experimental Medicine, University of Messina, 98125;Messina, Italy.;Department of Biomedical and Dental Sciences and Morphological and Functional;Imaging, University of Messina, 98125 Messina, Italy.;Department of Human Pathology of Adult and Childhood "Gaetano Barresi",;University of Messina, 98125 Messina, Italy.;Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38543150/ |
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