在中度至重度慢性阻塞性肺疾病（COPD）且不常发作的患者中，与丙酸氟替卡松/沙美特罗相比，乌美溴铵/维兰特罗对肺功能的改善情况。
Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations.
作者信息
Donohue James F, Worsley Sally, Zhu Chang-Qing, Hardaker Liz, Church Alison
机构信息
Department of Medicine, University of North Carolina College of Medicine, Chapel Hill, NC 27599, USA.
The Respiratory Medicines Development Centre, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK.
出版信息
Respir Med. 2015 Jul;109(7):870-81. doi: 10.1016/j.rmed.2015.04.018. Epub 2015 May 8.
BACKGROUND
Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled corticosteroid/LABA) are approved maintenance therapies for chronic obstructive pulmonary disease (COPD). Two studies compared efficacy and safety of UMEC/VI with FP/SAL in patients with moderate-to-severe COPD with no exacerbations in the previous year.
METHODS
In these 12-week, multicenter, double-blind, parallel-group, double-dummy trials, randomized (1:1) patients received once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 250/50 mcg (DB2114930 n = 353 and 353; DB2114951 n = 349 and 348, respectively; intent-to-treat). Endpoints included 0-24 h weighted mean (wm) forced expiratory volume in 1 s (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, dyspnea, quality of life (QoL) and safety.
RESULTS
UMEC/VI demonstrated statistically significant, clinically meaningful improvements in lung function measures versus FP/SAL. For 0-24 h wmFEV1 (Day 84), improvements with UMEC/VI versus FP/SAL were 74 mL (95% confidence interval [CI]: 38-110; DB2114930) and 101 mL (63-139; DB2114951) (both p < 0.001). Trough FEV1 improvements were 82 mL (45-119) and 98 mL (59-137) (both p < 0.001) for UMEC/VI versus FP/SAL, respectively. Both treatments demonstrated similar, clinically meaningful improvements from baseline in dyspnea (Transition Dyspnea Index focal score >1 unit) and QoL (St George's Respiratory Questionnaire Total score >4-unit decrease) in both studies with no statistical differences between treatments. Adverse event rates were similar: 26 and 30% UMEC/VI; 27 and 31% FP/SAL.
CONCLUSIONS
Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in statistically significant, clinically meaningful improvements in lung function versus twice-daily FP/SAL 250/50 mcg in patients with moderate-to-severe COPD with infrequent exacerbations. Both treatments improved dyspnea and QoL.
CLINICAL TRIAL REGISTRATION
DB2114930/NCT01817764; DB2114951/NCT01879410.
背景
乌美溴铵（UMEC；长效毒蕈碱拮抗剂[LAMA]）/维兰特罗（VI；长效β2受体激动剂[LABA]）和丙酸氟替卡松/沙美特罗（FP/SAL）（吸入性糖皮质激素/LABA）是慢性阻塞性肺疾病（COPD）的获批维持治疗药物。两项研究比较了UMEC/VI与FP/SAL在既往一年无加重的中重度COPD患者中的疗效和安全性。
方法
在这些为期12周的多中心、双盲、平行组、双模拟试验中，随机（1:1）分配患者每日一次接受62.5/25微克的UMEC/VI或每日两次接受250/50微克的FP/SAL（DB2114930中n分别为353和353；DB2114951中n分别为349和348；意向性分析）。终点包括0至24小时加权平均（wm）第1秒用力呼气容积（FEV1）（第84天；主要终点）、谷值FEV1（第85天；次要终点）、其他肺功能终点、呼吸困难、生活质量（QoL）和安全性。
结果
与FP/SAL相比，UMEC/VI在肺功能指标方面显示出具有统计学意义的、临床意义显著的改善。对于0至24小时wmFEV1（第84天），UMEC/VI相对于FP/SAL的改善分别为74毫升（95%置信区间[CI]：38 - 1,10；DB2114930）和101毫升（63 - 139；DB2114951）（均p < 0.001）。UMEC/VI相对于FP/SAL的谷值FEV1改善分别为82毫升（45 - 119）和98毫升（59 - 137）（均p < 0.001）。在两项研究中，两种治疗方法在呼吸困难（过渡性呼吸困难指数焦点评分>1个单位）和QoL（圣乔治呼吸问卷总分>4分降低）方面均显示出与基线相比具有相似的、临床意义显著的改善，且治疗组之间无统计学差异。不良事件发生率相似：UMEC/VI为26%和30%；FP/SAL为27%和31%。
结论
在12周内每日一次给予62.5/25微克的UMEC/VI，与每日两次给予250/50微克的FP/SAL相比，在发作不频繁的中重度COPD患者中，肺功能有统计学意义的、临床意义显著的改善。两种治疗方法均改善了呼吸困难和QoL。
临床试验注册
DB2114930/NCT01817764；DB2114951/NCT01879410。
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