The number needed to treat (NNT) indicates the number of patients who need to be treated for one additional responder to be seen with one therapy compared with another in a defined time period. This analysis of the Early MAXimization of bronchodilation for improving chronic obstructive pulmonary disease (COPD) stability (EMAX) trial evaluated the NNT for benefit in symptomatic, inhaled corticosteroids (ICS)-free patients at low exacerbation risk treated with the longacting muscarinic antagonist (LAMA)/long-acting β 2 -agonist (LABA) umeclidinium/vilanterol (UMEC/VI) versus UMEC (a LAMA), or salmeterol (SAL; a LABA) over 24 weeks. Methods: This double-blind, parallel-group trial randomized patients 1:1:1 to 24 weeks of UMEC/VI 62.5/25 mcg once daily (n=812), UMEC 62.5 mcg once daily (n=804), or SAL 50 mcg twice daily (n=809). NNT was calculated for each outcome from the proportion of patients experiencing a clinically relevant improvement or avoiding deterioration (responders) with UMEC/VI versus UMEC or SAL. Response was defined as: ≥1-point improvement in Transient Dyspnea Index (TDI) score; ≥2-point reduction from baseline in Evaluating Respiratory Symptoms (E-RS) total score; ≥4-point reduction from baseline in St George's Respiratory Questionnaire (SGRQ) total score; ≥2-point reduction from baseline in COPD Assessment Test (CAT) total score; avoiding a moderate/severe exacerbation; or avoiding a clinically important deterioration (CID) event (defined as one or more of: a ≥100 mL decrease in trough forced expiratory volume in 1 second [FEV 1 ], a ≥4-point reduction in SGRQ score, or a moderate/severe exacerbation). NNT was calculated post hoc for the proportion of patients achieving ≥100 mL increase in FEV 1 . Results: Across all outcomes over 24 weeks, fewer patients needed to be treated with UMEC/VI for one additional responder versus SAL (Figure). Aside from SGRQ and exacerbations, for which an NNT 95% confidence interval (CI) upper limit could not be determined, UMEC/VI also resulted in a lower NNT versus UMEC. Over 24 weeks, for the majority of endpoints, the NNT was lower for comparisons of UMEC/VI versus SAL than for comparisons of UMEC/VI versus UMEC. Of the seven outcomes analyzed, the NNT most in favor of UMEC/VI versus UMEC or SAL was observed for FEV 1 responder rate. Conclusion: These findings provide evidence of greater clinical benefit across a range of clinical outcomes over 24 weeks in symptomatic, ICS-free patients at low exacerbation risk with UMEC/VI compared with LAMA or LABA monotherapy. These data may facilitate physicians' choice of maintenance therapy. Funding: GlaxoSmithKline (201749; NCT03034915).
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