Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-Universität Marburg, Germany.
Member of the German Centre for Lung Research (DZL), Baldingerstraße, Marburg 35043, Germany.
Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620968500. doi: 10.1177/1753466620968500.
Symptom relief is a key treatment goal in patients with chronic obstructive pulmonary disease (COPD). However, there are limited data available on the response to bronchodilator therapy in patients at low risk of exacerbations with different levels of symptom severity. This study compared treatment responses in patients with a range of symptom severities as indicated by baseline COPD assessment test (CAT) scores.
The 24-week EMAX trial evaluated the benefits of umeclidinium/vilanterol umeclidinium or salmeterol in symptomatic patients at low exacerbation risk who were not receiving inhaled corticosteroids. This analysis assessed lung function, symptoms, health status, and short-term deterioration outcomes in subgroups defined by a baseline CAT score [<20 () and ⩾20 (pre-specified)]. Outcomes were also assessed using fractional polynomial modelling with continuous transformations of baseline CAT score covariates.
Of the intent-to-treat population ( = 2425), 56% and 44% had baseline CAT scores of <20 and ⩾20, respectively. Umeclidinium/vilanterol demonstrated favourable improvements compared with umeclidinium and salmeterol for the majority of outcomes irrespective of the baseline CAT score, with the greatest improvements generally observed in patients with CAT scores <20. Fractional polynomial analyses revealed consistent improvements in lung function, symptoms and reduction in rescue medication use with umeclidinium/vilanterol umeclidinium and salmeterol across a range of CAT scores, with the largest benefits seen in patients with CAT scores of approximately 10-21.
Patients with symptomatic COPD benefit similarly from dual bronchodilator treatment with umeclidinium/vilanterol. Fractional polynomial analyses demonstrated the greatest treatment differences favouring dual therapy in patients with a CAT score <20, although benefits were seen up to scores of 30. This suggests that dual bronchodilation may be considered as initial therapy for patients across a broad range of symptom severities, not only those with severe symptoms (CAT ⩾20). NCT03034915, 2016-002513-22 (EudraCT number).
缓解症状是慢性阻塞性肺疾病（COPD）患者的主要治疗目标。然而，对于不同严重程度的症状且处于低加重风险的患者，支气管扩张剂治疗的反应数据有限。本研究比较了基线 COPD 评估测试（CAT）评分不同严重程度的患者的治疗反应。
为期 24 周的 EMAX 试验评估了在未接受吸入性皮质类固醇的低加重风险且有症状的患者中，乌美溴铵/维兰特罗与乌美溴铵或沙美特罗的获益。本分析评估了按基线 CAT 评分[<20（<）和⩾20（预设）]定义的亚组的肺功能、症状、健康状况和短期恶化结局。使用连续转换基线 CAT 评分协变量的分数多项式模型也评估了结局。
意向治疗人群（n=2425）中，基线 CAT 评分<20 和⩾20 的患者分别占 56%和 44%。乌美溴铵/维兰特罗与乌美溴铵和沙美特罗相比，无论基线 CAT 评分如何，均表现出有利于大多数结局的改善，在 CAT 评分<20 的患者中，改善通常更为明显。分数多项式分析显示，在一系列 CAT 评分中，乌美溴铵/维兰特罗、乌美溴铵和沙美特罗均可改善肺功能、症状并减少急救药物的使用，在 CAT 评分约为 10-21 的患者中获益最大。
有症状的 COPD 患者从乌美溴铵/维兰特罗双重支气管扩张剂治疗中获益相似。分数多项式分析显示，最有利于双重治疗的差异最大的是 CAT 评分<20 的患者，尽管在 CAT 评分高达 30 的患者中也观察到获益。这表明，对于具有广泛症状严重程度的患者，不仅是 CAT ⩾20 的患者，双重支气管扩张剂治疗可作为初始治疗。NCT03034915，2016-002513-22（EudraCT 编号）。
