INTRODUCTION: Limited prospective evidence is available to guide selection of first-line maintenance therapy in patients with COPD. This pre-specified analysis of the EMAX trial explored the efficacy and safety of dual- versus mono-bronchodilator therapy in maintenance-naïve and maintenance-treated patients. METHODS: The 24-week EMAX trial evaluated lung function, symptoms (including rescue medication use), exacerbations, and safety with umeclidinium/vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving inhaled corticosteroids. Maintenance-naïve and maintenance-treated subgroups were defined by maintenance bronchodilator use 30 days before screening. RESULTS: The analysis included 749 (31%) maintenance-naïve and 1676 (69%) maintenance-treated patients. For both subgroups, improvements from baseline in trough FEV(1) at Week 24 (primary endpoint) were greater with umeclidinium/vilanterol versus umeclidinium (mean difference [95% CI]; maintenance-naïve: 44 mL [1, 87]; maintenance-treated: 77 mL [50, 104]), and salmeterol (maintenance-naïve: 128 mL [85, 171]; maintenance-treated: 145 mL [118, 172]), and in rescue medication inhalations/day over 24 weeks versus umeclidinium (maintenance-naïve: -0.44 [-0.73, -0.16]; maintenance-treated: -0.28 [-0.45, -0.12]) and salmeterol (maintenance-naïve: -0.37 [-0.66, -0.09]; maintenance-treated: -0.25 [-0.41, -0.08]). In maintenance-naïve patients, umeclidinium/vilanterol numerically improved scores at Week 24 for Transition Dyspnea Index versus umeclidinium (0.37 [-0.21, 0.96]) and versus salmeterol (0.47 [-0.10, 1.05]) and Evaluating Respiratory Symptoms-COPD versus umeclidinium (-0.26 [-1.04, 0.53]) and versus salmeterol (-0.58 [-1.36, 0.20]), with similar improvements seen in maintenance-treated patients. All treatments were well tolerated across both subgroups. CONCLUSION: Similar to maintenance-treated patients, maintenance-naïve patients receiving umeclidinium/vilanterol showed greater improvements in lung function and symptoms compared with patients receiving umeclidinium or salmeterol. These findings provide support for the consideration of dual bronchodilator treatment in symptomatic maintenance-naïve patients with COPD.
- Bjermer, L.
- Boucot, I. H.
- Maltais, F.
- Kerwin, E. M.
- Naya, I. P.
- Tombs, L.
- Jones, P. W.
- Compton, C.
- Lipson, D. A.
- Vogelmeier, C. F.
Keywords
- COPD treatment
- first-line therapy
- maintenance-naïve
- salmeterol
- umeclidinium
- umeclidinium/vilanterol
- current affiliation is Medical Emerging Markets, GSK, Brentford, Middlesex, UK. IPN
- was an employee of GSK at the time of the study, holds stocks and shares in GSK, and
- was a contingent worker on assignment at AstraZeneca. IPN’s current affiliation is
- RAMAX Ltd, Bramhall, Cheshire, UK. LT is a contingent worker on assignment at GSK.
- FM has received research grants for participating in multicenter trials for
- AstraZeneca, Boehringer Ingelheim, GSK, Sanofi, and Novartis, and has received
- unrestricted research grants and personal fees from Boehringer Ingelheim, Grifols,
- and Novartis. LB has received honoraria for giving a lecture or attending an
- advisory board for Airsonett, ALK-Abello, AstraZeneca, Boehringer Ingelheim, Chiesi,
- GSK, Meda, Novartis and Teva. EMK has served on advisory boards, speaker panels or
- received travel reimbursement from for Amphastar, AstraZeneca, Boehringer Ingelheim,
- Connect Biopharma, GSK, Mylan, Novartis, Pearl, Sunovion, Teva, and Theravance and
- has received consulting fees from Cipla and GSK. CFV has received grants from
- AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Grifols, Novartis, and the German
- Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD
- (ASCONET), and has received personal fees from AstraZeneca, Boehringer Ingelheim,
- Berlin Chemie/Menarini, Chiesi, CSL Behring, GSK, Grifols, MedUpdate, Novartis,
- Nuvaira, and Teva. The authors report no other conflicts of interest in this work.
