Abstract
Background: To investigate efficacy of umeclidinium/vilanterol (UMEC/VI) in preventing clinically important deterioration (CID) in intent-to-treat (ITT) and maintenance-naïve (MN) populations with COPD.
Methods: Post hoc analysis of four 24-week, parallel-group, blinded trials comparing UMEC/VI 62.5/25mcg vs tiotropium (TIO) 18mcg (3 trials) or placebo (PBO; 1 trial). The main outcome was percentage of patients with ≥1 CID (composite endpoint: decrease from baseline trough forced expiratory volume in 1 second [FEV1; ≥100mL] and/or increase from baseline in St George's Respiratory Questionnaire total score[≥4 units]and/or a moderate/severe COPD exacerbation).
Results: Least squares means difference in trough FEV1 at 24 weeks with UMEC/VI vs TIO was 95mL in the ITT and 146mL in the MN population (both p<0.001), respectively. Similarly, with UMEC/VI vs PBO, the difference in trough FEV1 was 167mL in the ITT and 156mL in the MN population (both p<0.001), respectively. In both populations the risk of experiencing a CID was statistically significantly lower for UMEC/VI vs TIO or PBO (based on analysis of time to first CID; ITT population: UMEC/VI vs TIO: 41 vs 56%; HR: 0.62 [0.54, 0.71]; UMEC/VI vs PBO: 44 vs 75%; HR: 0.37 [0.30, 0.45]; MN population: UMEC/VI vs TIO: 41 vs 55%; HR: 0.66 [0.51, 0.85]; UMEC/VI vs PBO: 49 vs 72%; HR: 0.45 [0.33,0.62]; all p<0.001). Adverse events did not differ between comparators.
Conclusion: Dual therapy with UMEC/VI reduced the risk of CID in COPD vs TIO or PBO in both ITT and MN populations.
Funded by GSK. NCT/GSK study: 01316900/113360; 01316913/113374; 01777334/117115, 01313650/113373.
- Copyright ©ERS 2015