Ray Riju, Tombs Lee, Asmus Michael J, Boucot Isabelle, Lipson David A, Compton Chris, Naya Ian
US Medical Affairs, GSK, 5 Moore Drive, Research Triangle Park, North Carolina, 27709, USA.
Precise Approach Ltd, Contingent Worker on Assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.
Drugs Aging. 2018 Jul;35(7):637-647. doi: 10.1007/s40266-018-0558-y.
The aim of this pooled analysis was to assess the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) 62.5/25 µg dual bronchodilation versus placebo in elderly symptomatic patients with chronic obstructive pulmonary disease (COPD).
We conducted a post hoc pooled analysis of data from 10 randomized controlled trials (RCTs). Change from baseline (CFB) in trough forced expiratory volume in 1 s (FEV), proportion of FEV responders (≥ 100-mL increase from baseline), and safety were analyzed in patients aged < 65, ≥ 65, and ≥ 75 years on Days 28, 56, and 84 (12-week analysis of parallel-group design studies), Days 28, 56, 84, 112, 140, 168, and 169 (24-week analysis of parallel-group design studies), and Days 2, 42, and 84 (12-week analysis of crossover design studies).
The UMEC/VI intent-to-treat (ITT) populations comprised 2246, 1296, and 472 patients in the 12-week parallel-group, 24-week parallel-group, and 12-week crossover analysis, respectively (≥ 65 years: 36-44%; ≥ 75 years: 7-11%). The placebo ITT populations comprised 528, 280, and 505 patients, respectively (≥ 65 years: 37-41%; ≥ 75 years: 5-11%). Significant improvements in trough FEV and significantly greater proportions of FEV responders were seen with UMEC/VI compared with placebo in all analyses regardless of patient age or timepoint considered (p ≤ 0.023), except Day 84 trough FEV CFB in the 12-week crossover analysis in patients aged ≥ 75 years (p = 0.064). UMEC/VI safety profile was similar to placebo in all age groups.
In this pooled analysis of RCT data, once-daily UMEC/VI was well tolerated and provided clinically significant lung function benefits compared with placebo in younger and older patients with COPD.
GlaxoSmithKline (study 208125).
本汇总分析旨在评估62.5/25微克的乌美溴铵/维兰特罗（UMEC/VI）双重支气管扩张剂与安慰剂相比，在老年慢性阻塞性肺疾病（COPD）有症状患者中的疗效和安全性。
我们对10项随机对照试验（RCT）的数据进行了事后汇总分析。在第28、56和84天（平行组设计研究的12周分析）、第28、56、84、112、140、168和169天（平行组设计研究的24周分析）以及第2、42和84天（交叉设计研究的12周分析），对年龄＜65岁、≥65岁和≥75岁的患者，分析其1秒用力呼气容积（FEV）谷值相对于基线的变化（CFB）、FEV反应者比例（较基线增加≥100毫升）和安全性。
在12周平行组、24周平行组和12周交叉分析中，UMEC/VI意向性治疗（ITT）人群分别包括2246、1296和472例患者（≥65岁：36 - 44%；≥75岁：7 - 11%）。安慰剂ITT人群分别包括528、280和505例患者（≥65岁：37 - 41%；≥75岁：5 - 11%）。在所有分析中（无论患者年龄或所考虑的时间点），与安慰剂相比，UMEC/VI在FEV谷值方面有显著改善，且FEV反应者比例显著更高（p≤0.023），但在≥75岁患者的12周交叉分析中，第84天的FEV谷值CFB除外（p = 0.064）。在所有年龄组中，UMEC/VI的安全性与安慰剂相似。
在这项RCT数据的汇总分析中，与安慰剂相比，每日一次的UMEC/VI在年轻和老年COPD患者中耐受性良好，并能带来具有临床意义的肺功能改善。
葛兰素史克公司（研究208125）。
