Li Meng, Zhang Qing-Song, Liu Xin-Ling, Wang Hui-Ling, Liu Wei
School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou 450001, China.
School of Pharmaceutical Sciences, Zhengzhou Railway Vocational and Technical College, Zhengzhou 450002, China.
Pharmaceuticals (Basel). 2022 Nov 24;15(12):1455. doi: 10.3390/ph15121455.
Nirmatrelvir/ritonavir is approved for the treatment of adults and pediatric patients with mild to moderate COVID-19, but information on adverse events associated with its use is limited. We aim to evaluate adverse events with potential risk for nirmatrelvir/ritonavir using the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using the reporting odds ratio (ROR) method, and subset analysis based on patient age and gender, as well as sensitivity analysis restricting the type of reporter to healthcare professionals. Nirmatrelvir/ritonavir was the most commonly reported COVID-19 drug, and 87.66% of the outcomes were non-serious. The most frequently reported events were disease recurrence (40.43%), dysgeusia (17.55%), and diarrhea (8.80%). In disproportionality analysis, the use of nirmatrelvir/ritonavir was significantly associated with disease recurrence (ROR: 212.01, 95% CI: 162.85-276.01), whereas no signal of disease recurrence was detected for any other COVID-19 drug. Disease recurrence (ROR: 421.38, 95% CI: 273.60-648.99) was more significant when limiting the reporter type to healthcare professionals. No significant differences in adverse event reports were found based on patient gender or age. Our study confirms that the risk of serious adverse events is low with nirmatrelvir/ritonavir, but its association with disease recurrence should not be ignored.
奈玛特韦/利托那韦被批准用于治疗轻度至中度新冠病毒病的成人和儿科患者，但关于其使用相关不良事件的信息有限。我们旨在使用美国食品药品监督管理局不良事件报告系统（FAERS）评估奈玛特韦/利托那韦潜在风险的不良事件。使用报告比值比（ROR）方法进行不成比例分析，并基于患者年龄和性别进行亚组分析，以及将报告者类型限制为医疗保健专业人员的敏感性分析。奈玛特韦/利托那韦是报告最多的新冠病毒病治疗药物，87.66%的结果为非严重不良事件。最常报告的事件是疾病复发（40.43%）、味觉障碍（17.55%）和腹泻（8.80%）。在不成比例分析中，使用奈玛特韦/利托那韦与疾病复发显著相关（ROR：212.01，95%置信区间：162.85 - 276.01），而其他任何新冠病毒病治疗药物均未检测到疾病复发信号。将报告者类型限制为医疗保健专业人员时，疾病复发（ROR：421.38，95%置信区间：273.60 - 648.99）更为显著。基于患者性别或年龄，不良事件报告未发现显著差异。我们的研究证实，奈玛特韦/利托那韦严重不良事件风险较低，但其与疾病复发的关联不应被忽视。
