Table 3.
Annualised exacerbation rates and hospitalisations/ER treatments in the full ITT population and the subgroups with episodes of high as-needed reliever use (>6 inhalations/day on ≥1 study day) (Study B)
|
Treatment groups |
Risk or rate ratios (95% CI) |
|||||
|---|---|---|---|---|---|---|
| SAL/FLU FD + terbutaline | BUD/FORM FD + terbutaline | BUD/FORM maintenance and reliever therapy | BUD/FORM maintenance and reliever therapy vs. SAL/FLU FD + terbutaline | BUD/FORM maintenance and reliever therapy vs. BUD/FORM FD + terbutaline | BUD/FORM FD + terbutaline vs. SAL/FLU FD + terbutaline | |
|
Number of patients with episodes with > 6 inh./day as needed | ||||||
| All patients, n (%)*† |
156 (13.9) |
167 (15.1) |
124 (11.2) |
0.74 (0.59–0.94) |
0.65 (0.52–0.83) |
1.13 (0.91–1.41) |
| |
|
|
|
P = 0.014 |
P < 0.001 |
P = 0.26 |
|
Exacerbation rate. patient-year
-1
| ||||||
| All patients, annualised rate (events)*‡ |
0.38 (208) |
0.32 (173) |
0.24 (125) |
0.61 (0.49–0.76) |
0.72 (0.57–0.90) |
0.85 (0.69–1.04) |
| |
|
|
|
P < 0.001 |
P = 0.0048 |
P = 0.10 |
| High as-needed group, annualised rate (events)§ | ||||||
|
Post-index day to study end |
1.92 (94) |
1.50 (80) |
0.92 (37) |
0.48 (0.31–0.75) |
0.61 (0.39–0.97) |
0.78 (0.55–1.11) |
|
≤21 days post-index |
4.78 (41) |
3.02 (28) |
2.00 (14) |
0.42 (0.23–0.77) |
0.66 (0.35–1.25) |
0.63 (0.39–1.02) |
|
Severe exacerbation days | ||||||
| All patients, % rate (total days)*║ |
0.7 (1327) |
0.6 (1143) |
0.4 (692) |
0.53 (0.38–0.73) |
0.60 (0.42–0.86) |
0.88 (0.64–1.21) |
| |
|
|
|
P < 0.001 |
P < 0.01 |
NS |
| High as-needed group, % rate (total days)║ | ||||||
|
Post-index day to study end |
3.7 (667) |
2.8 (539) |
1.8 (259) |
0.47 (0.27–0.78) |
0.64 (0.34–1.15) |
0.74 (0.44–1.21) |
|
≤21 days post-index |
10.1 (315) |
6.0 (203) |
3.4 (88) |
0.34 (0.14–0.66) |
0.57 (0.23–1.16) |
0.60 (0.35–1.00) |
|
Hospitalisation/ER visit rate, patient-year
–1
| ||||||
| All patients, rate (events)*‡ |
0.16 (106) |
0.10 (72) |
0.10 (64) |
0.61 (0.44–0.83) |
0.88 (0.63–1.24) |
0.68 (0.51–0.92) |
| |
|
|
|
P = 0.0015 |
P = 0.47 |
P = 0.013 |
| High as-needed group, rate (events) § | ||||||
|
Post-index day to study end |
0.96 (47) |
0.74 (40) |
0.40 (16) |
0.41 (0.23–0.73) |
0.53 (0.30–0.95) |
0.78 (0.51–1.19) |
| ≤21 days post-index | 2.44 (21) | 1.08 (10) | 0.86 (6) | 0.35 (0.14–0.86) | 0.79 (0.29–2.18) | 0.44 (0.21–0.94) |
*All patients (ITT population); †Cox proportional hazard model (post hoc analysis); ‡Poisson regression (a priori analysis); §Poisson regression (post hoc analysis); ║Bootstrap procedure (post hoc analysis).
BUD/FORM = budesonide/formoterol; CI = confidence interval; ER = emergency room; FD = fixed-dose maintenance; inh. = inhalations; SAL/FLU = salmeterol/fluticasone.