乌美溴铵/维兰特罗在中国治疗慢性阻塞性肺疾病患者的上市后安全性监测研究

Safety of umeclidinium/vilanterol in Chinese patients in a real-world setting:a prospective,multicenter,single-arm,observational study

目的评估乌美溴铵/维兰特罗在真实世界临床实践中应用于中国患者的安全性。方法采用前瞻性、多中心、单臂、观察性研究,在2020年12月14日至2022年1月30日,从中国的14家研究中心纳入在真实世界临床实践中接受乌美溴铵/维兰特罗治疗的患者,共随访24周。研究主要结局为随访期内不良事件和严重不良事件的发生率。结果共纳入887例患者,年龄为(67.5±9.6)岁,其中男性689例(77.7%)。大多数患者(98.1%)有慢性阻塞性肺疾病史。468例患者(52.8%)报告了合并药物。在所有纳入的患者中,59例(6.7%)报告了不良事件,21例(2.4%)报告了严重不良事件,其中9例报告了致死性严重不良事件,10例报告了非致死性严重不良事件,2例同时报告了非致死性和致死性严重不良事件。所有严重不良事件,包括致死性事件,经研究者判定均与乌美溴铵/维兰特罗无关。6例(0.7%)发生药物不良反应,其严重程度均为轻度。3例(0.3%)患者报告的不良事件属于重要已确定或潜在风险,经研究者判定均与乌美溴铵/维兰特罗无关。结论乌美溴铵/维兰特罗在真实世界临床实践中应用于中国患者具有良好的安全性,未观察到与该药相关的新的安全性信号。

Objective To evaluate the safety of umeclidinium/vilanterol in Chinese participants in a real-world setting.Methods This was a 24-week,prospective,multicenter,single-arm,observational study that enrolled participants treated with umeclidinium/vilanterol in real-world settings from 14 sites in China from 14 December 2020 to 30 January 2022.The primary outcomes were the incidence of adverse events(AEs)and serious adverse events(SAEs)at week 24.Results A total of 887 participants on umeclidinium/vilanterol were enrolled.The mean(±SD)age of these participants was 67.5(±9.6)years,with more men(77.7%)enrolled.The majority of the participants(98.1%)had been diagnosed with chronic obstructive pulmonary disease,and 67.6%of them reported comorbidities.More than half of the participants(52.8%)were taking concomitant medication in addition to the study treatment.AEs were reported in 59(6.7%)participants and were predominantly mild to moderate in severity.SAEs were reported in 21(2.4%)participants,including 9 fatal SAEs,10 reported non-fatal SAEs,and 2 reported both non-fatal and fatal SAEs.None of the SAEs,including the fatal events,were considered by the investigators to be related to umeclidinium/vilanterol.Adverse drug reactions(ADRs)were reported in 6(0.7%)participants with 4 preferred terms(PTs),all of which were considered mild in severity.Of these PTs,2 were known ADRs of umeclidinium/vilanterol.Three participants(0.3%)reported AEs that were part of serious identified/potential hazards,all of which were considered by the investigators to be unrelated to umeclidinium/vilanterol.Conclusion The results of this study showed that umeclidinium/vilanterol was well tolerated in Chinese participants in a real-world setting and no new drug-related safety signals were observed.