乌美溴铵/维兰特罗在 COPD 现吸烟者和曾吸烟者中的疗效和安全性：EMAX 试验的预先指定分析。
Efficacy and Safety of Umeclidinium/Vilanterol in Current and Former Smokers with COPD: A Prespecified Analysis of The EMAX Trial.
机构信息
Respiratory Medicine and Allergology, Skane University Hospital, Lund University, 221 85, Lund, Sweden.
GSK, Brentford, Middlesex, UK.
出版信息
Adv Ther. 2021 Sep;38(9):4815-4835. doi: 10.1007/s12325-021-01855-y. Epub 2021 Aug 4.
INTRODUCTION
Smoking may reduce the efficacy of inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD), but its impact on bronchodilator efficacy is unclear. This analysis of the EMAX trial explored efficacy and safety of dual- versus mono-bronchodilator therapy in current or former smokers with COPD.
METHODS
The 24-week EMAX trial evaluated lung function, symptoms, health status, exacerbations, clinically important deterioration, and safety with umeclidinium/vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving ICS. Current and former smoker subgroups were defined by smoking status at screening.
RESULTS
The analysis included 1203 (50%) current smokers and 1221 (50%) former smokers. Both subgroups demonstrated greater improvements from baseline in trough FEV at week 24 (primary endpoint) with umeclidinium/vilanterol versus umeclidinium (least squares [LS] mean difference, mL [95% CI]; current: 84 [50, 117]; former: 49 [18, 80]) and salmeterol (current: 165 [132, 198]; former: 117 [86, 148]) and larger reductions in rescue medication inhalations/day over 24 weeks versus umeclidinium (LS mean difference [95% CI]; current: - 0.42 [- 0.63, - 0.20]; former: - 0.25 - 0.44, - 0.05]) and salmeterol (current: - 0.28 [- 0.49, - 0.06]; former: - 0.29 [- 0.49, - 0.09]). Umeclidinium/vilanterol increased the odds (odds ratio [95% CI]) of clinically significant improvement at week 24 in Transition Dyspnea Index versus umeclidinium (current: 1.54 [1.16, 2.06]; former: 1.32 [0.99, 1.75]) and salmeterol (current: 1.37 (1.03, 1.82]; former: 1.60 [1.20, 2.13]) and Evaluating Respiratory Symptoms-COPD versus umeclidinium (current: 1.54 [1.13, 2.09]; former: 1.50 [1.11, 2.04]) and salmeterol (current: 1.53 [1.13, 2.08]; former: 1.53 [1.12, 2.08]). All treatments were well tolerated in both subgroups.
CONCLUSIONS
In current and former smokers, umeclidinium/vilanterol provided greater improvements in lung function and symptoms versus umeclidinium and salmeterol, supporting consideration of dual-bronchodilator therapy in symptomatic patients with COPD regardless of their smoking status.
简介
吸烟可能会降低慢性阻塞性肺疾病（COPD）患者吸入皮质类固醇（ICS）的疗效，但吸烟对支气管扩张剂疗效的影响尚不清楚。对 EMAX 试验的这项分析探讨了当前或曾经吸烟的 COPD 患者中，双支气管扩张剂与单支气管扩张剂治疗的疗效和安全性。
方法
24 周的 EMAX 试验评估了在低加重风险且未使用 ICS 的症状性患者中，乌美溴铵/维兰特罗、乌美溴铵和沙美特罗对肺功能、症状、健康状况、加重、临床显著恶化和安全性的影响。当前和曾经吸烟者亚组根据筛查时的吸烟状况来定义。
结果
分析纳入了 1203 名（50%）当前吸烟者和 1221 名（50%）曾经吸烟者。与乌美溴铵相比，两组亚组在第 24 周的谷值 FEV 均有更大的改善（主要终点），乌美溴铵/维兰特罗（最小二乘[LS]均值差异，mL [95%CI]；当前：84 [50，117]；曾经：49 [18，80]）和沙美特罗（当前：165 [132，198]；曾经：117 [86，148]），且在 24 周内与乌美溴铵相比，使用抢救性吸入药物的次数更少（LS 均值差异[95%CI]；当前：-0.42 [-0.63，-0.20]；曾经：-0.25 -0.44，-0.05]）和沙美特罗（当前：-0.28 [-0.49，-0.06]；曾经：-0.29 [-0.49，-0.09]）。与乌美溴铵相比，乌美溴铵/维兰特罗在第 24 周时增加了临床显著改善的几率（比值比[95%CI]），在过渡性呼吸困难指数方面优于乌美溴铵（当前：1.54 [1.16，2.06]；曾经：1.32 [0.99，1.75]）和沙美特罗（当前：1.37 [1.03，1.82]；曾经：1.60 [1.20，2.13]），在评估呼吸症状-COPD 方面也优于乌美溴铵（当前：1.54 [1.13，2.09]；曾经：1.50 [1.11，2.04]）和沙美特罗（当前：1.53 [1.13，2.08]；曾经：1.53 [1.12，2.08]）。两组亚组中所有治疗均耐受良好。
结论
在当前和曾经吸烟者中，乌美溴铵/维兰特罗在改善肺功能和症状方面优于乌美溴铵和沙美特罗，支持在有症状的 COPD 患者中考虑使用双支气管扩张剂治疗，无论其吸烟状况如何。
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