State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Xinqiao Hospital, Third Military Medical University, Chongqing, China.
Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7.
Chronic obstructive pulmonary disease (COPD) is becoming a leading cause of morbidity and mortality in China. In the IMPACT trial, fluticasone furoate[FF]/umeclidinium[UMEC]/vilanterol[VI] single-inhaler triple therapy demonstrated lower rates of moderate/severe exacerbations than dual therapy with FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations. This analysis investigates the China cohort and its consistency with the overall ITT population.
10,355 patients were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg, or UMEC/VI 62.5/25 µg for 52 weeks. Endpoints included: annual rates of exacerbations, time-to-first on-treatment moderate/severe exacerbation and change from baseline in trough forced expiratory volume in 1 s (FEV) at Week-52. Clinical trial registration is NCT02164513 (CTT116855).
535 patients (5.2%) were from China. Annual on-treatment moderate/severe exacerbation rate was 0.81 with FF/UMEC/VI versus 0.96 with FF/VI (rate ratio: 0.84; 95% confidence interval [CI]: 0.64, 1.11; = .227) and 0.80 with UMEC/VI (rate ratio: 1.02; 95% CI: 0.72, 1.44; = .929). Hazard ratio for time-to-first moderate/severe exacerbation was 0.84 (95% CI: 0.63, 1.11; = .218) for FF/UMEC/VI versus FF/VI and 0.89 (95% CI: 0.62, 1.27; = .516) versus UMEC/VI. Significant improvements in mean change from baseline in trough FEV were observed for FF/UMEC/VI versus FF/VI (treatment difference 137 mL; 95% CI: 86, 188; < .001) and UMEC/VI (63 mL; 0, 125; = .050). Health status was improved with FF/UMEC/VI versus both dual therapies. Results were similar to the overall ITT population. No new safety signals were identified.
Single-inhaler triple therapy with FF/UMEC/VI versus FF/VI or UMEC/VI reduced the rate and risk of exacerbations, and improved lung function and health status in the China cohort similar to the overall ITT population. No new safety signals were identified.
慢性阻塞性肺疾病（COPD）在中国正成为发病率和死亡率的主要原因。在 IMPACT 试验中，糠酸氟替卡松[FF]/乌美溴铵[UMEC]/维兰特罗[VI]三联单吸入器治疗在有症状 COPD 和加重史的患者中，与 FF/VI 或 UMEC/VI 双联治疗相比，中度/重度加重的发生率较低。本分析调查了中国队列及其与总体意向治疗人群的一致性。
10355 例患者随机分为 2:2:1 接受每日一次 FF/UMEC/VI 100/62.5/25μg、FF/VI 100/25μg 或 UMEC/VI 62.5/25μg，治疗 52 周。终点包括：加重的年发生率、首次治疗中度/重度加重的时间和第 52 周时从基线到呼气量（FEV）的谷值变化。临床试验注册号为 NCT02164513（CTT116855）。
535 例患者（5.2%）来自中国。与 FF/VI 相比，FF/UMEC/VI 的治疗性中重度加重年发生率为 0.81（发生率比：0.84；95%置信区间[CI]：0.64，1.11； = .227），与 UMEC/VI 相比为 0.80（发生率比：1.02；95% CI：0.72，1.44； = .929）。与 FF/VI 相比，FF/UMEC/VI 首次出现中重度加重的风险比为 0.84（95% CI：0.63，1.11； = .218），与 UMEC/VI 相比为 0.89（95% CI：0.62，1.27； = .516）。与 FF/VI 相比，FF/UMEC/VI 组和 UMEC/VI 组的平均治疗后第 52 周时从基线到呼气量（FEV）的谷值变化均有显著改善（治疗差异 137mL；95% CI：86，188； < .001）。与 UMEC/VI 相比（63mL；0，125； = .050）。与双药治疗相比，FF/UMEC/VI 治疗可改善健康状况。结果与总体意向治疗人群相似。未发现新的安全信号。
与 FF/VI 或 UMEC/VI 相比，FF/UMEC/VI 三联单吸入器治疗可降低中国队列患者的加重发生率和风险，并改善肺功能和健康状况，与总体意向治疗人群相似。未发现新的安全信号。
