Chapman Kenneth R, Bateman Eric D, Chen Hungta, Hu Hulin, Fogel Robert, Banerji Donald
Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Ontario, Canada.
Department of Medicine, University of Cape Town, South Africa.
Chronic Obstr Pulm Dis. 2015 Jan 1;2(1):48-60. doi: 10.15326/jcopdf.2.1.2014.0140.
: QVA149 is a dual bronchodilator combining the long-acting β-agonist(LABA) indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium, for maintenance treatment of COPD. This post hoc analysis evaluated the improvements in lung function, dyspnea, and health status in subgroups of patients based on prior medication use, disease severities, baseline cough score, and baseline rescue medication use, achieved with QVA149 compared with placebo and other active comparators in 2 phase III clinical studies. : In both the SHINE (NCT01202188) and ILLUMINATE (NCT01315249) studies, symptomatic patients aged ≥40 years with moderate-to-severe COPD were randomized to once-daily QVA149 (110/50 µg), indacaterol (150 µg), glycopyrronium (50 µg), tiotropium (18 μg), or placebo (2:2:2:2:1) and once-daily QVA149 (110/50 µg) or twice-daily salmeterol/fluticasone ([SFC]; 50/500 µg), respectively for 26 weeks. Here, we present the improvements in lung function, transition dyspnea index (TDI) and St. George's Respiratory Questionnaire (SGRQ) total score by prior medication use and COPD disease severity separately from both studies. : In total, 2144 and 523 patients were randomized in the SHINE and ILLUMINATE studies; 89.1% and 82.6%, respectively, completed the study. QVA149 showed significant improvements in lung function compared with placebo (SHINE study) and SFC (ILLUMINATE study) regardless of prior medication, disease severity, baseline cough score, and rescue medication use. TDI and SGRQ total scores were also improved with QVA149 compared with placebo and SFC in most of the analyzed subgroups. QVA149 showed improvements in lung function, dyspnea, and health status in both moderate and severe COPD patients independent of previous medication use and baseline cough score.
QVA149是一种双重支气管扩张剂,它将长效β受体激动剂(LABA)茚达特罗和长效毒蕈碱拮抗剂(LAMA)格隆溴铵结合在一起,用于慢性阻塞性肺疾病(COPD)的维持治疗。这项事后分析评估了在两项III期临床研究中,与安慰剂和其他活性对照药物相比,QVA149在基于既往用药情况、疾病严重程度、基线咳嗽评分和基线急救药物使用情况划分的患者亚组中,肺功能、呼吸困难和健康状况的改善情况。:在SHINE(NCT01202188)和ILLUMINATE(NCT01315249)两项研究中,年龄≥40岁的中重度COPD症状性患者被随机分为每日一次的QVA149(110/50微克)、茚达特罗(150微克)、格隆溴铵(50微克)、噻托溴铵(18微克)或安慰剂(2:2:2:2:1)组,以及每日一次的QVA149(110/50微克)或每日两次的沙美特罗/氟替卡松([SFC];50/500微克)组,分别治疗26周。在此,我们分别展示了两项研究中按既往用药情况和COPD疾病严重程度划分的肺功能、过渡性呼吸困难指数(TDI)和圣乔治呼吸问卷(SGRQ)总分的改善情况。:在SHINE和ILLUMINATE研究中,分别有2144例和523例患者被随机分组;分别有89.1%和82.6%的患者完成了研究。无论既往用药情况、疾病严重程度、基线咳嗽评分和急救药物使用情况如何,与安慰剂(SHINE研究)和SFC(ILLUMINATE研究)相比,QVA149在肺功能方面均显示出显著改善。在大多数分析的亚组中,与安慰剂和SFC相比,QVA149在TDI和SGRQ总分方面也有所改善。QVA149在中度和重度COPD患者中均显示出肺功能、呼吸困难和健康状况的改善,且与既往用药情况和基线咳嗽评分无关。