| アブストラクト | Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir's safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised concerns regarding the potential cardiac events associated with remdesivir; therefore, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency requested to investigate all available data. Therefore, we analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on cardiac adverse events. From April to December 2020, 1375 ICSRs related to remdesivir were retrieved from EudraVigilance, of which 863 (62.8%) were related to male and (43.3%) adult patients. A total of 82.2% of all AEs (N = 2604) was serious and one third of the total ICSRs (N = 416, 30.3%) had a fatal outcome. The most frequently reported events referred to hepatic/hepatobiliary disorders (19.4%,), renal and urinary disorders (11.1%) and cardiac events (8.4%). Among 221 cardiac ICSRs, 69 reported fatal outcomes. Other drugs for cardiovascular disorders were reported as suspected/concomitant together with remdesivir in 166 ICSRs (75.1%), 62 of which were fatal. Moreover, the mean time to overall cardiac event was 3.3 days (+/-2.2). Finally, disproportionality analysis showed a two-fold increased risk of reporting a cardiac adverse event associated with remdesivir compared to both hydroxychloroquine and azithromycin. This study showed that remdesivir could be associated to risk of cardiac events, suggesting a potential safety signal which has not been completely evaluated yet. Further studies are needed to confirm these findings. |
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| 投稿日 | 2021/7/3 |
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| 投稿者 | Rafaniello, Concetta; Ferrajolo, Carmen; Sullo, Maria Giuseppa; Gaio, Mario; Zinzi, Alessia; Scavone, Cristina; Gargano, Francesca; Coscioni, Enrico; Rossi, Francesco; Capuano, Annalisa |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| 組織名 | Campania Regional Centre for Pharmacovigilance and;Pharmacoepidemiology-Department of Experimental Medicine-Section of Pharmacology;"L. Donatelli", University of Campania "Luigi Vanvitelli", Via Costantinopoli,;16, 80138 Naples, Italy.;Department of Anesthesia and Resuscitation, Biomedical Campus University of Rome,;00128 Rome, Italy.;AGENAS-Agenzia Nazionale per i Servizi Sanitari Regionali, Via Piemonte 60, 00187;Roma, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34202350/ |
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