| アブストラクト | Introduction: The discovery of serine protease proprotein convertase subtilisin-kexin type 9 (PCSK9) has revolutionized pharmacological lipid-lowering treatments. The first PCSK9 antagonists (PCSK9-A), evolocumab and alirocumab, were approved in 2015. Targeting PCSK9 synthesis marked a major advancement in this field, leading to the development of inclisiran, a long-acting siRNA targeting PCSK9 mRNA. However, real-world safety data on this drug are still limited. Therefore, this study aims to provide a real-world safety evaluation of inclisiran, comparing its characteristics to those of PCSK9-As. Methods: A retrospective pharmacovigilance study was conducted using EudraVigilance (EV). Inclisiran-related individual case safety reports (I-ICSRs) from 01/01/2021 to 06/30/2023 were retrieved. ICSRs for evolocumab or alirocumab from 01/01/2015 to 06/30/2023 were collected as a reference group (RG). ADRs were classified using the MedDRA dictionary. Data were evaluated using descriptive and disproportionality analyses. Crude reporting odds ratio (ROR) with 95% confidence intervals (CI) were used as disproportionality measures. Results: Of the 15,236 ICSRs, 3.7% (n = 563) involved inclisiran, with the rest in the RG. Most I-ICSRs involved female patients (51.7%) aged 18 to 64 (52.8%). The most-reported ADRs for inclisiran were "general disorders and administration site conditions" (n = 347) and "investigations" (n = 277). Significant disproportionality was found in I-ICSRs compared to the RG for "Myalgia" (ROR: 2.43; 95% CI: 1.94-3.04), "Low-density lipoprotein increased" (ROR: 11.95; 95% CI: 9.10-15.52), and "Drug ineffective" (ROR: 6.37; 95% CI: 4.64-8.74). Conclusions: The inclisiran safety profile aligns with the existing literature and pre-commercial data. However, further studies are needed to fully understand the observed differences with PCSK9-As. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2024/10/26 |
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| 投稿者 | Cicala, Giuseppe; Rottura, Michelangelo; Gianguzzo, Viviana Maria; Cristiano, Federica; Drago, Selene Francesca Anna; Pallio, Giovanni; Irrera, Natasha; Imbalzano, Egidio; Spina, Edoardo; Arcoraci, Vincenzo |
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| 組織名 | Department of Clinical and Experimental Medicine, University of Messina, 98125;Messina, Italy.;Department of Chemical, Biological, Pharmaceutical and Environmental Sciences,;University of Messina, 98166 Messina, Italy.;Department of Biomedical and Dental Sciences and Morphological and Functional;Imaging, University of Messina, 98125 Messina, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39459005/ |
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