Department of Otolaryngology-Head and Neck Surgery, University of Washington, Seattle, Washington, USA.
Department of Otolaryngology-Head and Neck Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Otolaryngol Head Neck Surg. 2023 Jul;169(1):55-61. doi: 10.1002/ohn.278. Epub 2023 Feb 5.
A novel COVID-19 therapeutic, nirmatrelvir/ritonavir (Paxlovid), is commonly associated with reports of dysgeusia. The Food and Drug Administration Adverse Event Reporting System (FAERS) database was used to determine the real-world reporting of Paxlovid-associated dysgeusia (PAD), identify associated factors, and describe the relative reporting rates of dysgeusia for Paxlovid compared to other COVID-19 therapeutics (OCT), ritonavir alone, and other protease inhibitors (OPI).
Observational retrospective.
Tertiary academic medical center.
We collected patient and adverse event characteristics reported in the FAERS database between January 1968 and September 2022. Disproportionality analyses were used to compare the reporting of PAD to dysgeusia reported for OCT, ritonavir, and OPI.
345,229 adverse events were included in the present study. Dysgeusia was a frequently reported Paxlovid-associated adverse event (17.5%) and was associated with nonserious COVID-19 infection (reporting odds ratio [ROR] 1.4; 95% confidence interval [CI] 1.2, 1.7) and female sex (ROR = 1.7; 95% CI 1.6, 1.9). Paxlovid was more likely to be associated with the reporting of dysgeusia compared to OCT (ROR 305.4; 95% CI 164.1, 568.5), ritonavir (ROR 28.0; 95% CI 24.1, 32.7), and OPI (ROR 49.0; 95% CI 42.8, 56.1).
Dysgeusia is much more likely to be reported by patients receiving Paxlovid than those receiving OCT, ritonavir alone, or OPI. These findings suggest a potential mechanism of dysgeusia that causes distorted taste out of proportion to the background effects of COVID-19 infection and specific to nirmatrelvir. Future studies are needed to determine the underlying pathophysiology and long-term clinical implications for patients who report dysgeusia with Paxlovid.
一种新型的 COVID-19 治疗药物，尼马曲韦/利托那韦（Paxlovid），常与味觉障碍的报告有关。本研究利用食品和药物管理局不良事件报告系统（FAERS）数据库来确定 Paxlovid 相关味觉障碍（PAD）的真实世界报告，确定相关因素，并描述 Paxlovid 与其他 COVID-19 治疗药物（OCT）、利托那韦单独使用和其他蛋白酶抑制剂（OPI）相比味觉障碍的相对报告率。
观察性回顾性研究。
三级学术医疗中心。
我们收集了 FAERS 数据库中 1968 年 1 月至 2022 年 9 月期间报告的患者和不良事件特征。使用不相称性分析比较 PAD 与 OCT、利托那韦和 OPI 报告的味觉障碍。
本研究共纳入 345229 例不良事件。味觉障碍是 Paxlovid 常见的不良事件（17.5%），与非严重 COVID-19 感染相关（报告比值比[ROR] 1.4；95%置信区间[CI] 1.2，1.7）和女性（ROR=1.7；95%CI 1.6，1.9）。与 OCT（ROR 305.4；95%CI 164.1，568.5）、利托那韦（ROR 28.0；95%CI 24.1，32.7）和 OPI（ROR 49.0；95%CI 42.8，56.1）相比，Paxlovid 更有可能与味觉障碍的报告相关。
接受 Paxlovid 的患者比接受 OCT、利托那韦单独或 OPI 的患者更有可能报告味觉障碍。这些发现提示味觉障碍的潜在机制可能是 COVID-19 感染的背景效应之外，还与尼马曲韦有关，导致味觉扭曲不成比例。需要进一步研究以确定报告味觉障碍的患者的潜在病理生理学和长期临床意义。
