Gilead Sciences, Inc., 333 Lakeside Dr, Foster City, CA, USA.
Gilead Sciences, Inc., 333 Lakeside Dr, Foster City, CA, USA.
Respir Investig. 2024 Mar;62(2):192-199. doi: 10.1016/j.resinv.2023.12.016. Epub 2024 Jan 6.
To evaluate the occurrence of adverse drug reactions (ADRs) and to assess mortality and health status in participants receiving remdesivir in real-world settings in Japan.
This postmarketing surveillance study used an all-case surveillance method for enrollment. Participants with SARS-CoV-2 infection administered remdesivir from July 2020 to November 2021 in Japan were eligible for inclusion. The observation period was from remdesivir treatment initiation to 4 weeks after the end of treatment or treatment discontinuation. Clinical status and outcomes were analyzed by Kaplan-Meier plots and compared across subgroups at baseline, Day 14, Day 28, and the final observation point.
The analysis included 2128 participants (mean age, 67 years; 71.4 % male; 84.1 % with current comorbidities). ADRs and serious adverse drug reactions (SADRs) were reported among 10.4 % and 1.2 % participants, respectively. Overall, 191/2127 participants died (mortality rate [95 % confidence interval], 11.10 [9.66-12.75] per 100 person-months), 1511/2127 showed clinical improvement (117.8 [112.0-123.9] per 100 person-months), 1392/2127 recovered (103.9 [98.6-110.0] per 100 person-months), and 216/324 were extubated (107.0 [93.6-122.3] per 100 person-months).
The incidence of ADRs and SADRs was low, and no new safety concerns were identified. Observed mortality and clinical improvement results were consistent with prior studies, confirming remdesivir's benefits in real-world settings in Japan.
评估在日本真实环境中接受瑞德西韦治疗的患者发生药物不良反应（ADR）的情况，并评估死亡率和健康状况。
本项上市后监测研究采用全病例监测方法进行入组。2020 年 7 月至 2021 年 11 月期间，在日本感染 SARS-CoV-2 并接受瑞德西韦治疗的患者符合入组条件。观察期为从瑞德西韦治疗开始至治疗结束或停药后 4 周。通过 Kaplan-Meier 图分析临床状况和结局，并在基线、第 14 天、第 28 天和最终观察点比较各亚组之间的差异。
本分析纳入了 2128 例患者（平均年龄 67 岁；71.4%为男性；84.1%合并有基础疾病）。10.4%和 1.2%的患者分别报告了药物不良反应和严重药物不良反应。总的来说，2127 例患者中有 191 例死亡（死亡率[95%置信区间]为每 100 人月 11.10[9.66-12.75]），1511 例患者临床改善（每 100 人月 117.8[112.0-123.9]），1392 例患者康复（每 100 人月 103.9[98.6-110.0]），324 例中有 216 例拔管（每 100 人月 107.0[93.6-122.3]）。
ADR 和 SADR 的发生率较低，未发现新的安全性问题。观察到的死亡率和临床改善结果与既往研究一致，证实了瑞德西韦在日本真实环境中的获益。
