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 FEV₁ 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.

中文翻译：

---

Umeclidinium/Vilanterol 对 COPD 吸烟者和既往吸烟者的疗效和安全性：EMAX 试验的预设分析

介绍

吸烟可能会降低吸入性皮质类固醇（ICS）对慢性阻塞性肺病（COPD）患者的疗效，但其对支气管扩张药疗效的影响尚不清楚。对 EMAX 试验的分析探讨了双用与单用支气管扩张剂治疗对当前或曾经吸烟的 COPD 患者的疗效和安全性。

方法

为期 24 周的 EMAX 试验评估了未接受 ICS 的低恶化风险有症状患者的肺功能、症状、健康状况、恶化、临床上重要的恶化和使用 umeclidinium/vilanterol、umeclidinium 和沙美特罗的安全性。当前和以前的吸烟者亚组由筛查时的吸烟状况定义。

结果

分析包括 1203 名（50%）当前吸烟者和 1221 名（50%）前吸烟者。两个亚组的 FEV _{1谷值较基线均有较大改善}在第 24 周（主要终点），使用 umeclidinium/vilanterol 与 umeclidinium（最小二乘 [LS] 均值差，mL [95% CI]；当前：84 [50, 117]；前者：49 [18, 80]）和沙美特罗（当前：165 [132, 198]；前：117 [86, 148]）和 24 周内救援药物吸入/天的更大减少与 umeclidinium 相比（LS 平均差异 [95% CI]；当前：- 0.42 [- 0.63， - 0.20]；前：- 0.25 - 0.44，- 0.05]）和沙美特罗（当前：- 0.28 [- 0.49，- 0.06]；前：- 0.29 [- 0.49，- 0.09]）。与umeclidinium（当前：1.54 [1.16, 2.06]；前者：1.32 [0.99, 1.75]）和沙美特罗（当前：1.37 (1.03, 1.82]；前：1.60 [1.20, 2. 13]）和评估呼吸系统症状 - COPD 与 umeclidinium（当前：1.54 [1.13, 2.09]；前者：1.50 [1.11, 2.04]）和沙美特罗（当前：1.53 [1.13, 2.08]；前者：1.53 [1.12, 2.08] ）。在两个亚组中，所有治疗均具有良好的耐受性。

结论

在当前和既往吸烟者中，与乌美溴铵和沙美特罗相比，乌美溴铵/维兰特罗在肺功能和症状方面提供了更大的改善，支持考虑对有症状的慢性阻塞性肺病患者进行双支气管扩张剂治疗，无论其吸烟状况如何。