| アブストラクト | INTRODUCTION: The high mortality of Coronavirus Disease 2019 (COVID-19) highlights the need for safe and effective antiviral treatment. Small molecular antivirals (remdesivir, molnupiravir, nirmatrelvir/ritonavir) and immunomodulators (baricitinib, tocilizumab) have been developed or repurposed to suppress viral replication and ameliorate cytokine storms, respectively. Despite U.S. Food and Drug Administration (FDA) approval, serious cardiovascular adverse events (CVAEs) may not be apparent in initial trials. METHODS: A retrospective analysis of CVAEs linked to five World Health Organization (WHO) recommended COVID-19 therapies was conducted using the WHO VigiBase database from March 2020 to July 2023. Adjusted reporting odds ratios (aROR) with 95% confidence intervals (CI) were calculated to assess CVAE risks. RESULTS: A total of 276,631 AEs were reported to be associated with COVID-19, of which 13,091 were classified as cardiovascular events. Remdesivir was associated with significantly increased odds of CVAEs, particularly bradycardia (aROR 2.4, 95% CI 2.28-2.52). In contrast, nirmatrelvir/ritonavir and molnupiravir showed reduced CVAEs odds. Among immunomodulators, baricitinib was associated with increased CVAEs risk (aROR 2.31, 95% CI 2.07-2.59), with deep vein thrombosis being the most prominent (aROR 45.34, 95% CI 34.89-58.9), accounting for 38.8% of reported study cases in the database. Also, CVAEs odds were higher during the Omicron period compared to pre-Omicron period. CONCLUSIONS: These findings highlight the importance of continued pharmacovigilance and suggest potential CV safety differences among COVID-19 immunomodulators. Since tocilizumab and baricitinib are similarly indicated for severe patients with COVID-19, further clinical trials are warranted to explore whether tocilizumab represents a safer alternative to baricitinib for these patients. Insights from this study may guide future antiviral repurposing and pandemic preparedness strategies. |
| ジャーナル名 | Infectious diseases and therapy |
| Pubmed追加日 | 2025/9/11 |
| 投稿者 | Cheng, Hoi K; Lai, Angel; Kwok, Maxwell; Yan, Bryan P; Poon, Ellen Ngar-Yun |
| 組織名 | Division of Cardiology, Department of Medicine and Therapeutics, Faculty of;Medicine, The Chinese University of Hong Kong (CUHK), Hong Kong SAR, China.;School of Biomedical Sciences, The Chinese University of Hong Kong (CUHK), Hong;Kong SAR, China.;Hong Kong Hub of Paediatric Excellence (HK HOPE), The Chinese University of Hong;Kong (CUHK), Hong Kong SAR, China.;bryan.yan@cuhk.edu.hk.;Heart and Vascular Institute, The Chinese University of Hong Kong (CUHK), Hong;Kong SAR, China. bryan.yan@cuhk.edu.hk.;Kong SAR, China. ellen.poon@cuhk.edu.hk.;Kong (CUHK), Hong Kong SAR, China. ellen.poon@cuhk.edu.hk.;Centre for Cardiovascular Genomics and Medicine, Lui Che Woo Institute of;Innovative Medicine, The Chinese University of Hong Kong (CUHK), Hong Kong SAR,;China. ellen.poon@cuhk.edu.hk.;Ministry of Education Key Laboratory for Regenerative Medicine, The Chinese;University of Hong Kong (CUHK), Hong Kong SAR, China. ellen.poon@cuhk.edu.hk. |
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40931314/ |