Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns.
Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns.
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DOI：
10.1016/j.cmi.2021.02.013
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发表时间：
2021-02-27
期刊：
影响因子：
--
通讯作者：
Montastruc F
中科院分区：
文献类型：
--
作者：
Touafchia A;Bagheri H;Carrié D;Durrieu G;Sommet A;Chouchana L;Montastruc F
在最近的临床试验中，报告了一些心律失常与使用Remdesivir治疗COVID-19有关。为了解决这一安全性问题，我们调查了使用Remdesivir治疗COVID-19是否与心动过缓风险增加相关。使用世界卫生组织全球个案安全性报告数据库VigiBase®，我们比较了暴露于瑞德西韦的COVID-19患者报告的心动过缓病例与暴露于羟氯喹、洛匹那韦/利托那韦、托珠单抗或糖皮质激素的COVID-19患者报告的心动过缓病例。所有截至二零二零年九月二十三日登记的COVID-19患者报告均已纳入。我们进行了相关性分析，以估计报告比值比（ROR）和95% CI。在2603例COVID-19患者使用Remdesivir处方的报告中，我们发现了302例心脏效应，包括94例心动过缓（31%）。94份报告中的大多数为严重（75，80%），16份报告（17%）的进展为致死性。与羟氯喹、洛匹那韦/利托那韦、托珠单抗或糖皮质激素相比，使用Remdesivir与报告心动过缓的风险增加相关（ROR 1.65; 95%CI 1.23-2.22）。在其他敏感性分析中观察到一致的结果。这项在真实环境中进行的上市后研究表明，与使用羟氯喹、洛匹那韦/利托那韦、托珠单抗或糖皮质激素相比，使用Remdesivir与报告心动过缓和严重心动过缓的风险增加显著相关。该结果与Remdesivir的药效学特性一致。
In recent clinical trials some cardiac arrhythmias were reported with use of remdesivir for COVID-19. To address this safety concern, we investigated whether use of remdesivir for COVID-19 is associated with an increased risk of bradycardia. Using VigiBase®, the World Health Organization Global Individual Case Safety Reports database, we compared the cases of bradycardia reported in COVID-19 patients exposed to remdesivir with those reported in COVID-19 patients exposed to hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. All reports of patients with COVID-19 registered up to the 23 September 2020 were included. We conducted disproportionality analyses allowing the estimation of reporting odds ratios (RORs) with 95% CI. We found 302 cardiac effects including 94 bradycardia (31%) among the 2603 reports with remdesivir prescribed in COVID-19 patients. Most of the 94 reports were serious (75, 80%), and in 16 reports (17%) evolution was fatal. Compared with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids, the use of remdesivir was associated with an increased risk of reporting bradycardia (ROR 1.65; 95% CI 1.23–2.22). Consistent results were observed in other sensitivity analyses. This post-marketing study in a real-world setting suggests that the use of remdesivir is significantly associated with an increased risk of reporting bradycardia and serious bradycardia when compared with the use of with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. This result is in line with the pharmacodynamic properties of remdesivir.
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影响因子：
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作者：
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DOI：
10.1111/cts.12882
发表时间：
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期刊：
Clinical and translational science
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