Lv Bing, Gao Xin, Zeng Guoqiang, Guo Hui, Li Faping
Department of Emergency, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
Department of Urology, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
Curr Pharm Des. 2024;30(9):666-675. doi: 10.2174/0113816128280987240214103432.
With the urgent and widespread application of Paxlovid, a novel antiviral drug for Coronavirus Disease 2019 (COVID-19) in clinical practice, concerns regarding its actual efficacy and safety have emerged. In order to provide more evidence to support its clinical application, we sought to perform a descriptive analysis of cases who experienced at least one Paxlovid-related adverse event (AEs) and reported to the FDA Adverse Event Reporting System (FAERS) in the post-marketing period.
Individual adverse event reports between January 1, 2022 and September 30, 2022, were downloaded from the FAERS website. We completed a descriptive study about the safety of Paxlovid in the treatment of COVID-19. Further, we also analyzed the onset time of Paxlovid-related AEs.
As of 30 September 2022, 16,529 de-duplicated cases were submitted to the FDA, and 5,860 (35.45%) were female. The average age was 58.38 years (S.D. 15.50). Most reports (12,390, 74.96%) were submitted by consumers and 1,436 (8.68%) concerned serious outcomes. The most frequently reported AEs were disease recurrence (7,724, 16.23%), dysgeusia (2,877, 6.05%), and diarrhoea (1,448, 3.04%). The median onset time of Paxlovid-related AEs was 8 days (interquartile range,1-10 days), and most of the cases (2,629, 19.12%) occurred on the day after Paxlovid initiation.
This study indicates that the most common AEs reported with Paxlovid in post-marketing experience are consistent with the safety assessment of antiviral drugs. Even without emerging apparent safety concerns, the incidence of serious outcomes was unexpectedly high, and a few cases of potential new AEs occurred.
随着新型抗2019冠状病毒病（COVID-19）药物帕罗韦德在临床实践中的紧急广泛应用，人们对其实际疗效和安全性产生了担忧。为了提供更多证据支持其临床应用，我们试图对上市后在接受帕罗韦德治疗时至少发生过1例与帕罗韦德相关不良事件（AE）并向美国食品药品监督管理局不良事件报告系统（FAERS）报告的病例进行描述性分析。
从FAERS网站下载了2022年1月1日至2022年9月30日期间的个体不良事件报告。我们完成了一项关于帕罗韦德治疗COVID-19安全性的描述性研究。此外，我们还分析了与帕罗韦德相关不良事件的发病时间。
截至2022年9月30日，向美国食品药品监督管理局提交了16529例去重病例，其中5860例（35.45%）为女性。平均年龄为58.38岁（标准差15.50）。大多数报告（12390例，74.96%）由消费者提交，1436例（8.68%）涉及严重后果。报告最频繁的不良事件为疾病复发（7724例，16.23%）、味觉障碍（2877例，6.05%）和腹泻（1448例，3.04%）。与帕罗韦德相关不良事件的中位发病时间为8天（四分位间距，1 - 10天），大多数病例（共2629例，19.12%）发生在开始使用帕罗韦德后的第1天。
本研究表明，上市后经验中报告的与帕罗韦德相关的最常见不良事件与抗病毒药物的安全性评估一致。即使没有出现明显的安全问题，严重后果的发生率也出乎意料地高，并且出现了几例潜在的新不良事件。
