Table 2.
Percentage risk reduction (95% CI) for a first moderate/severe exacerbation
| UMEC/VI vs PBO | UMEC vs PBO | VI vs PBO | UMEC/VI vs UMEC | UMEC/VI vs VI | |
|---|---|---|---|---|---|
| Patient group/subgroup | |||||
| ITT population (N = 3021) |
58 (40, 71)
p < 0.001 |
44 (22, 60)
p < 0.001 |
39 (15, 56)
p = 0.003 |
24 (−9, 48) p = 0.136 |
31 (2, 52)
p = 0.041 |
| Patient subgroups | |||||
| Maintenance-naïve (n = 984) |
62 (15, 83)
p = 0.018 |
22 (−55, 61) p = 0.475 |
4 (−82, 49) p = 0.904 |
51 (−8, 77) p = 0.076 |
60 (16, 81)
p = 0.016 |
| On maintenance (n = 2037) |
56 (35, 71)
p < 0.001 |
50 (27, 66)
p < 0.001 |
48 (24, 65)
p < 0.001 |
12 (−33, 42) p = 0.540 |
16 (−27, 45) p = 0.408 |
| ICS-free (n = 1543) |
62 (30, 80)
p = 0.002 |
41 (−3, 66) p = 0.063 |
15 (−41, 49) p = 0.520 |
36 (−20, 66) p = 0.166 |
55 (19, 75)
p = 0.008 |
| ICS-treated (n = 1478) |
55 (30, 71)
p < 0.001 |
46 (19, 65)
p = 0.003 |
51 (25, 68)
p = 0.001 |
15 (−33, 46) p = 0.470 |
7 (−48, 42) p = 0.753 |
| Low rescue use (n = 1488) |
71 (43, 85)
p < 0.001 |
51 (12, 72)
p = 0.018 |
32 (−16, 61) p = 0.153 |
41 (−18, 70) p = 0.135 |
57 (17, 78)
p = 0.012 |
| High rescue use (n = 1490) |
49 (22, 67)
p = 0.002 |
43 (13, 62)
p = 0.009 |
45 (15, 64)
p = 0.006 |
12 (−38, 44) p = 0.580 |
9 (−44, 42) p = 0.699 |
Risk of a first moderate/severe exacerbation was assessed using a Cox proportional hazards model for all medication subgroups separately, with covariates for study, treatment, smoking status at screening and center group. Bold values indicate statistical significance (p < 0.05)
Low rescue use: < 3.6 puffs/day; high rescue use: ≥ 3.6 puffs/day
CI confidence interval, ICS inhaled corticosteroid, ITT intent-to-treat, LS least squares, PBO placebo, UMEC umeclidinium, VI vilanterol