Demographic characteristics of the patients included in the biomarker substudy conducted in the USA and that of the worldwide participants
| Biomarker substudy | SUMMIT population | |
| n=1673 | n=16 485 | |
| Age, years | 66 (8) | 65 (8) |
| Women | 635 (38%) | 4196 (25%) |
| BMI, kg/m2 | 31 (7) | 28 (6) |
| Smoking status | ||
| Current smoker | 828 (49%) | 7678 (47%) |
| Smoking history (pack-years) | 52 (29) | 41 (24) |
| Respiratory status | ||
| Postbronchodilator FEV1 (L) | 1.7 (0.4) | 1.7 (0.4) |
| Predicted postbronchodilator FEV1 (%) | 59 (7) | 60 (6) |
| Exacerbations in 12 months before study | ||
| 0 | 1215 (73%) | 10 021 (61%) |
| 1 | 290 (17%) | 4020 (24%) |
| 2+ | 168 (10%) | 2444 (15%) |
| Cardiovascular inclusion criteria | ||
| Manifest disease | ||
| Coronary artery disease | 818 (49%) | 8379 (51%) |
| Peripheral arterial disease | 384 (23%) | 3145 (19%) |
| Previous stroke | 172 (10%) | 1595 (10%) |
| Previous myocardial infarction | 413 (25%) | 2774 (17%) |
| Diabetes with target organ disease | 226 (14%) | 1503 (9%) |
| At risk | ||
| Hypercholesterolaemia | 1072 (64%) | 8479 (51%) |
| Hypertension | 1166 (70%) | 11 478 (70%) |
| Diabetes mellitus | 447 (27%) | 3480 (21%) |
| Peripheral arterial disease | 106 (6%) | 1154 (7%) |
| Concomitant medications | ||
| Antiplatelet | 1081 (65%) | 8517 (52%) |
| Beta-blocker | 787 (47%) | 5667 (34%) |
| ACE inhibitor | 779 (47%) | 7655 (46%) |
| Statin | 1263 (75%) | 10 721 (65%) |
| Long-acting muscarinic antagonist | 168 (10%) | 818 (5%) |
| Xanthine (including theophylline) | 78 (5%) | 3719 (23%) |
| Treatment allocation | ||
| Placebo | 439 (26%) | 4111 (25%) |
| Fluticasone furoate | 415 (25%) | 4135 (25%) |
| Vilanterol | 416 (25%) | 4118 (25%) |
| Combination therapy | 403 (24%) | 4121 (25%) |
Continuous variables are mean (SD); categorical variables are n and (%).
BMI, body mass index;FEV1, forced expiratory volume in 1 s;SUMMIT, Study to Understand Mortality and MorbidITy.