Primary outcomes for exacerbations at 3 and 6 months in patients with chronic obstructive pulmonary disease who received budesonide/formoterol or formoterol
| Group D# | Group B¶ | Group D subgroups | ||||||||
| D1+ | D2§ | D3ƒ | ||||||||
| BUD/FORM | FORM | BUD/FORM | FORM | BUD/FORM | FORM | BUD/FORM | FORM | BUD/FORM | FORM | |
| Patients n | 1044 | 1050 | 128 | 124 | 564 | 565 | 69 | 87 | 411 | 398 |
| Patients with ≥1 event n (%) | ||||||||||
| Time to first exacerbation | ||||||||||
| 3 months | 142 (14) | 226 (22) | 9 (7) | 14 (11) | 64 (11) | 103 (18) | 10 (14) | 17 (20) | 68 (17) | 106 (27) |
| 6 months | 250 (24) | 330 (31) | 21 (16) | 24 (19) | 117 (21) | 154 (27) | 13 (19) | 24 (28) | 120 (29) | 152 (38) |
| Time to first exacerbation or drop-out | ||||||||||
| 3 months | 203 (19) | 320 (30) | 18 (14) | 28 (23) | 98 (17) | 153 (27) | 14 (20) | 22 (25) | 91 (22) | 144 (36) |
| 6 months | 364 (35) | 461 (44) | 35 (27) | 46 (37) | 177 (31) | 229 (41) | 23 (32) | 32 (37) | 163 (40) | 199 (50) |
| Risk reduction % (hazard ratio, 95% CI)## | ||||||||||
| Time to first exacerbation | ||||||||||
| 3 months | 41 (0.59, 0.48–0.73) | 41 (0.59, 0.23–1.36) | 41 (0.59, 0.43–0.80) | 26 (0.74, 0.34–1.61) | 43 (0.57, 0.42–0.77) | |||||
| 6 months | 31 (0.69, 0.58–0.81) | 24 (0.76, 0.43–1.37) | 31 (0.69, 0.55–0.88) | 33 (0.67, 0.34–1.32) | 33 (0.67, 0.52–0.85) | |||||
| Time to first exacerbation or drop-out | ||||||||||
| 3 months | 41 (0.59, 0.50–0.70) | 42 (0.58, 0.32–1.06) | 40 (0.60, 0.46–0.77) | 20 (0.80, 0.47–1.55) | 44 (0.56, 0.43–0.72) | |||||
| 6 months | 29 (0.71, 0.62–0.82) | 33 (0.67, 0.43–1.04) | 30 (0.70, 0.58–0.85) | 11 (0.89, 0.52–1.52) | 44 (0.56, 0.43–0.72) | |||||
Group D (high risk of exacerbations): post-bronchodilator (post-BD) forced expiratory volume in 1 s (FEV1) <50% predicted and/or two or more exacerbations in the previous year, and modified Medical Research Council (mMRC) dyspnoea score of ≥2. Group B (lower risk of exacerbations): post-BD FEV1 ≥50% predicted and one or fewer exacerbations in the previous year, and mMRC score of ≥2. D1: post-BD FEV1 <50% predicted. D2: two or more exacerbations in the previous year. D3: post-BD FEV1 <50% predicted and two or more exacerbations in the previous year. BUD: budesonide; FORM: formoterol. #: n=2094; ¶: n=252; +: n=1129; §: n=156; ƒ: n=809; ##: hazard ratio and 95% confidence intervals for reductions in time to first exacerbation, and time to first exacerbation or drop-out for BUD/FORM versus FORM, as calculated using SAS v9.2 (SAS Institute Inc., Cary, NC, USA).