Real-life effectiveness of indacaterol–glycopyrronium after switching from tiotropium or salmeterol/fluticasone therapy in patients with symptomatic COPD: the POWER study
Received 27 August 2018
Accepted for publication 29 November 2018
Published 18 January 2019 Volume 2019:14 Pages 249—260
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Richard Russell
Alan Kaplan,1 Kenneth R Chapman,2 Syed M Anees,3 Irvin Mayers,4 Driss Rochdi,5 Michel Djandji,5 David Préfontaine,5 Andrew McIvor6
1Family Physician Airways Group of Canada, University of Toronto, Toronto, ON, Canada; 2Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada; 3Schulich School of Medicine & Dentistry – Western University, University of Windsor, ON, Canada; 4Division of Pulmonary Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada; 5Novartis Pharmaceuticals Canada Inc., Montreal, QC, Canada; 6Department of Medicine, McMaster University, Firestone Institute for Respiratory Health, Hamilton, ON, Canada
Purpose: In contrast to randomized controlled trials (RCTs), changes in maintenance pharmacotherapy in clinical practice occur without a washout period. The Prospective cohort study for the real-life effectiveness evaluation of glycOpyrronium With indacatERol combination in the management of COPD in Canada (POWER) study evaluated the real-life effectiveness of indacaterol/glycopyrronium (IND/GLY) following a direct switch from a long-acting muscarinic antagonist (LAMA, tiotropium) or long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) maintenance treatment (salmeterol/fluticasone [SFC]).
Methods: POWER was a single-cohort, prospective, multicenter, interventional study in which patients with moderate-to-severe COPD, who remained symptomatic on their current treatment of once-daily (od) tiotropium 18 µg or twice-daily (bid) SFC (any dose), were switched to treatment with open-label IND/GLY 110/50 µg od for 16 weeks. Effectiveness end points were change from baseline in trough FEV1, transition dyspnea index (TDI) total scores, and COPD assessment test (CAT) scores at 16 weeks.
Results: Trough FEV1 improved by 175 mL at Week 16 in patients who switched to IND/GLY. The change was 176 mL (95% CI: 135–217) when switched from tiotropium and 172 mL (95% CI: 85–258) when switched from SFC fixed-dose combination (FDC). At Week 16, significant improvements were observed in the mean TDI total scores (Δ=2.5) and CAT scores (Δ=-6.5) after the switch to IND/GLY treatment (both P<0.0001). Additionally, IND/GLY was well tolerated in patients with moderate-to-severe COPD, and no safety signal was observed.
Conclusion: In clinical practice settings, a direct switch from previous treatment with either tiotropium or SFC to IND/GLY was safe and provided superior clinically significant improvements in lung function and patient-related outcomes in patients with moderate-to-severe COPD.
Clinical trial registration: NCT02202616.
Keywords: COPD assessment test, dyspnea, FEV1, indacaterol/glycopyrronium, lung function, TDI