Efficacy and Safety of Umeclidinium/Vilanterol in Current and Former Smokers with COPD: A Prespecified Analysis of The EMAX Trial

Abstract

Introduction: Smoking may reduce the efficacy of inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD), but its impact on bronchodilator efficacy is unclear. This analysis of the EMAX trial explored efficacy and safety of dual-versus mono-bronchodilator therapy in current or former smokers with COPD. Methods: The 24-week EMAX trial evaluated lung function, symptoms, health status, exacerbations, clinically important deterioration, and safety with umeclidinium/vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving ICS. Current and former smoker subgroups were defined by smoking status at screening. Results: The analysis included 1203 (50%) current smokers and 1221 (50%) former smokers. Both subgroups demonstrated greater improvements from baseline in trough FEV 1 at week 24 (primary endpoint) with umeclidinium/vilanterol versus umeclidinium (least squares [LS] mean

How can the findings of the EMAX trial on long-acting bronchodilation in chronic obstructive pulmonary disease be applied in the primary care setting?

“…[24][25][26] Both current and former smokers (50% each) showed improved trough FEV 1 , reduced rescue medication use, and improved odds of experiencing a clinically meaningful improvement in symptoms with UMEC/VI versus monotherapy. 27 Finally, improvements in trough FEV 1 and reductions in rescue medication at Week 24 use were greater with UMEC/VI versus monotherapy across the full range of baseline reversibility values. 28…”

“…Both current and former smokers (50% each) showed improved trough FEV 1 , reduced rescue medication use, and improved odds of experiencing a clinically meaningful improvement in symptoms with UMEC/VI versus monotherapy. 27 …”

Applying key learnings from the EMAX trial to clinical practice and future trial design in COPD

“…In a pre-specified subgroup analysis, the additional treatment benefit of UMEC/VI over UMEC or SAL on lung function and rescue medication use was apparent in both current and former smokers (Fig. 2) [24]. This suggests that the utility of dual bronchodilator therapy with UMEC/VI is not limited by smoking, in contrast with evidence suggesting that efficacy of ICS may be blunted in current smokers [25].…”