Baseline characteristics of study participants by body mass index (BMI) category
| Underweight <20 kg·m−2 | Normal 20– <25 kg·m−2 | Overweight 25– <30 kg·m−2 | Class I obesity 30– <35 kg·m−2 | Class II obesity 35– <40 kg·m−2 | Class III obesity ≥40 kg·m−2 | |
| Subjects n | 1111 | 4306 | 5662 | 3452 | 1367 | 587 |
| Demographics | ||||||
| BMI (kg·m−2) | 18.3±1.3 | 22.9±1.4 | 27.4±1.4 | 32.1±1.4 | 37.0±1.4 | 44.0±4.0 |
| Age years | 65.4±8.4 | 65.8±8.0 | 65.5±7.9 | 65.0±7.5 | 63.4±7.8 | 62.3±7.8 |
| Female | 229 (21%) | 941 (22%) | 1373 (24%) | 946 (27%) | 455 (33%) | 252 (43%) |
| Race | ||||||
| White | 468 (42%) | 2941 (68%) | 4841 (85%) | 3236 (94%) | 1314 (96%) | 557 (95%) |
| Asian | 625 (56%) | 1262 (29%) | 694 (12%) | 126 (4%) | 13 (<1%) | 3 (<1%) |
| Other | 18 (2%) | 103 (2%) | 127 (2%) | 90 (3%) | 40 (3%) | 27 (5%) |
| Region | ||||||
| USA | 75 (7%) | 443 (10%) | 859 (15%) | 655 (19%) | 344 (25%) | 214 (36%) |
| Europe | 340 (31%) | 2322 (54%) | 3700 (65%) | 2365 (69%) | 889 (65%) | 302 (51%) |
| Asia | 625 (56%) | 1245 (29%) | 681 (12%) | 120 (3%) | 12 (<1%) | 3 (<1%) |
| Rest of world | 71 (6%) | 296 (7%) | 422 (7%) | 312 (9%) | 122 (9%) | 68 (12%) |
| Current smokers | 617 (56%) | 2281 (53%) | 2589 (46%) | 1389 (40%) | 570 (42%) | 232 (40%) |
| Smoking history (pack-years) | 39.1±23.6 | 40.4±23.4 | 40.2±23.8 | 41.8±25.1 | 42.4±27.1 | 41.9±26.3 |
| Lung function | ||||||
| Post-BD FEV1 (L) at screening | 1.5±0.4 | 1.6±0.4 | 1.7±0.4 | 1.7±0.4 | 1.7±0.4 | 1.7±0.4 |
| % Predicted post-BD FEV1 at screening | 60.0±6.3 | 59.8±6.2 | 59.8±6.1 | 59.4±5.9 | 59.2±6.1 | 58.9±6.1 |
| FEV1 reversibility (% of pre-BD FEV1) at screening | 7.6±12.2 | 8.1±12.2 | 8.1±11.6 | 8.0±12.0 | 9.0±12.4 | 9.0±12.2 |
| Pre-study COPD exacerbations in 12 months before study | ||||||
| 0 | 717 (65%) | 2675 (62%) | 3390 (60%) | 2065 (60%) | 828 (61%) | 346 (59%) |
| 1 | 233 (21%) | 1009 (23%) | 1418 (25%) | 888 (26%) | 338 (25%) | 134 (23%) |
| ≥2 | 161 (14%) | 622 (14%) | 854 (15%) | 499 (14%) | 201 (15%) | 107 (18%) |
| Cardiovascular inclusion criteria# | ||||||
| Manifest disease | ||||||
| Coronary artery disease | 445 (40%) | 2056 (48%) | 2951 (52%) | 1868 (54%) | 745 (54%) | 314 (53%) |
| Peripheral arterial disease | 245 (22%) | 841 (20%) | 1096 (19%) | 629 (18%) | 234 (17%) | 100 (17%) |
| Previous stroke | 147 (13%) | 439 (10%) | 546 (10%) | 309 (9%) | 108 (8%) | 46 (8%) |
| Previous myocardial infarction | 144 (13%) | 653 (15%) | 967 (17%) | 666 (19%) | 246 (18%) | 98 (17%) |
| Diabetes with target organ disease | 58 (5%) | 237 (6%) | 458 (8%) | 414 (12%) | 230 (17%) | 106 (18%) |
| At risk | ||||||
| Hypercholesterolaemia | 547 (49%) | 2467 (57%) | 3579 (63%) | 2300 (67%) | 906 (66%) | 391 (67%) |
| Hypertension | 833 (75%) | 3506 (81%) | 4931 (87%) | 3183 (92%) | 1274 (93%) | 538 (92%) |
| Diabetes mellitus | 200 (18%) | 818 (19%) | 1395 (25%) | 1103 (32%) | 588 (43%) | 272 (46%) |
| Peripheral arterial disease | 130 (12%) | 420 (10%) | 564 (10%) | 309 (9%) | 100 (7%) | 54 (9%) |
| SUMMIT treatment assignment | ||||||
| Fluticasone furoate | 298 (27%) | 1086 (25%) | 1420 (25%) | 860 (25%) | 336 (25%) | 135 (23%) |
| Vilanterol | 280 (25%) | 1061 (25%) | 1400 (25%) | 881 (26%) | 325 (24%) | 171 (29%) |
| Fluticasone furoate/vilanterol | 280 (25%) | 1052 (24%) | 1437 (25%) | 857 (25%) | 344 (25%) | 151 (26%) |
| Placebo | 253 (23%) | 1107 (26%) | 1405 (25%) | 854 (25%) | 362 (26%) | 130 (22%) |
Data are presented as mean±sd or n (%), unless otherwise stated. FEV1: forced expiratory volume in 1 s; BD: bronchodilator. #: patients could have several cardiovascular diseases or risks at study entry.