Table 1 Baseline characteristics (ITT population)
| FF/UMEC/VI N = 4151 | FF/VI N = 4134 | UMEC/VI N = 2070 | Overall N = 10,355 | |
|---|---|---|---|---|
| Age, mean (SD), years | 65.3 (8.2) | 65.3 (8.3) | 65.2 (8.3) | 65.3 (8.3) |
| Gender, male, n (%) | 2766 (67) | 2748 (66) | 1356 (66) | 6870 (66) |
| BMI, mean (SD), kg/m2 | 26.6 (6.2) | 26.7 (6.1) | 26.6 (5.9) | 26.6 (6.1) |
| Smoking status, n (%) | ||||
| Current smoker | 1436 (35) | 1423 (34) | 728 (35) | 3587 (35) |
| Former smoker | 2715 (65) | 2711 (66) | 1342 (65) | 6768 (65) |
| Moderate or severe COPD exacerbations in previous year, n (%) | ||||
| 0 | 2 (< 1) | 5 (< 1) | 2 (< 1) | 9 (< 1) |
| 1 | 1853 (45) | 1907 (46) | 931 (45) | 4691 (45) |
| 2 | 1829 (44) | 1768 (43) | 890 (43) | 4487 (43) |
| ≥3 | 467 (11) | 454 (11) | 247 (12) | 1168 (11) |
| Post-bronchodilator FEV1% predicted, mean (SD) | 47.5 (15.0) | 45.5 (14.8) | 45.4 (14.7) | 45.5 (14.8) |
| Current/past Cardiac disordersa, n (%) | 1194 (29) | 1173 (28) | 597 (29) | 2964 (29) |
| Current/past Vascular disordersa, n (%) | 2362 (57) | 2438 (59) | 1221 (59) | 6021 (58) |
| CV risk factorsa, n (%) | ||||
| 0 | 1365 (33) | 1322 (32) | 656 (32) | 3343 (32) |
| 1 | 1147 (28) | 1158 (28) | 580 (28) | 2885 (28) |
| ≥1 | 2786 (67) | 2812 (68) | 1414 (68) | 7012 (68) |
| ≥2 | 1639 (39) | 1654 (40) | 834 (40) | 4127 (40) |
| CV risk factorsa, n (%) | ||||
| Hypertension | 2132 (51) | 2207 (53) | 1107 (53) | 5446 (53) |
| Hypercholesterolemia | 1354 (33) | 1332 (32) | 681 (33) | 3367 (33) |
| Diabetes mellitus | 641 (15) | 645 (16) | 313 (15) | 1599 (15) |
| Coronary artery disease | 510 (12) | 488 (12) | 254 (12) | 1252 (12) |
| Arrhythmia | 335 (8) | 323 (8) | 158 (8) | 816 (8) |
| Angina pectoris | 291 (7) | 307 (7) | 139 (7) | 737 (7) |
| Myocardial infarction | 270 (7) | 274 (7) | 137 (7) | 681 (7) |
| Congestive heart failure | 223 (5) | 192 (5) | 124 (6) | 539 (5) |
| Cerebrovascular accident | 199 (5) | 165 (4) | 94 (5) | 458 (4) |
| Vascular diseaseb | 133 (3) | 148 (4) | 61 (3) | 342 (3) |
| Family history of CV risk factorsa, n (%)c | ||||
| Premature coronary artery diseased | ||||
| Yes | 432 (10) | 430 (10) | 234 (11) | 1096 (11) |
| No | 3160 (76) | 3097 (75) | 1529 (74) | 7786 (75) |
| Unknown | 559 (13) | 607 (15) | 307 (15) | 1473 (14) |
| Myocardial infarction | ||||
| Yes | 651 (16) | 673 (16) | 361 (17) | 1685 (16) |
| No | 3004 (72) | 2954 (71) | 1431 (69) | 7389 (71) |
| Unknown | 496 (12) | 507 (12) | 278 (13) | 1281 (12) |
| Stroke | ||||
| Yes | 448 (11) | 464 (11) | 230 (11) | 1142 (11) |
| No | 3191 (77) | 3150 (76) | 1565 (76) | 7906 (76) |
| Unknown | 512 (12) | 520 (13) | 275 (13) | 1307 (13) |