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. 2016 Sep 9;3(4):758-768.
doi: 10.15326/jcopdf.3.4.2016.0138.

Efficacy of Indacaterol/Glycopyrronium in Patients with COPD Who Have Increased Dyspnea with Daily Activities

Donald A Mahler  1 , Dorothy L Keininger  2 , Karen Mezzi  2 , Robert Fogel  3 , Donal Banerji  3
Affiliations

Efficacy of Indacaterol/Glycopyrronium in Patients with COPD Who Have Increased Dyspnea with Daily Activities

Donald A Mahler et al. Chronic Obstr Pulm Dis. .

Abstract

Introduction: The Global initiative for chronic Obstructive Lung Disease (GOLD) recommends treating patients with chronic obstructive pulmonary disease (COPD) based on a combined assessment of symptom severity and airflow limitation and/or exacerbation risk. According to GOLD, patients with mild-to-moderate airflow limitation and distressing symptoms such as dyspnea should be treated with a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA). If symptoms persist on monotherapy, GOLD recommends a combination of bronchodilators (LABA/LAMA). Methods: We performed a post-hoc analysis of data from two 26-week, prospective clinical trials to investigate the effect of treating patients with moderate-to-severe dyspnea with the once-daily LABA/LAMA combination indacaterol/glycopyrronium (IND/GLY) 110/50 µg compared with placebo, once-daily tiotropium 18 µg, and twice-daily salmeterol/fluticasone propionate (SFC) 50/500 µg. In this analysis, a Baseline Dyspnea Index (BDI) score ≤7 was used to identify dyspneic patients. Results: In dyspneic patients, IND/GLY significantly improved Transition Dyspnea Index (TDI) total scores compared with tiotropium (0.59 units; p<0.05) and SFC (0.97 units; p<0.05), and significantly increased the likelihood of a patient achieving a 1-unit improvement in TDI compared with tiotropium (odds ratio [OR] 1.87; p<0.05). IND/GLY also significantly improved trough forced expiratory volume in 1 second (FEV1) compared with tiotropium and SFC (p<0.001 and p<0.0001, respectively), and significantly reduced rescue medication use compared with tiotropium (p<0.001). Conclusions: Our analysis indicates that IND/GLY provides additional improvements in dyspnea and lung function compared with tiotropium and SFC in dyspneic patients.

Keywords: Baseline Dyspnea Index; QVA149; Transition Dyspnea Index; chronic obstructive pulmonary disease; copd; dual bronchodilation; glycopyrronium; indacaterol; screening questionnaire.

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Conflict of interest statement

Donald Mahler has received consulting fees for advisory boards from Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sunovion, and Theravance. He receives royalties from CRC Press, from Hillcrest Media Group Inc, and from MAPI Research Trust. He is on speakers’ bureaus for Boehringer Ingelheim, GlaxoSmithKline, and Sunovion. His website (http://www.donaldmahler.com) is an educational website for those with COPD and their families. Dorothy Keininger, Karen Mezzi, Robert Fogel, and Donald Banerji are full-time employees of Novartis. Robert Fogel and Donald Banerji own stock in Novartis.

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