Figures
- FIGURE 1
All-cause mortality by body mass index (BMI) category. Adjusted for age, sex, region, race, ischaemic heart disease, vascular disease, smoking status, cardiovascular history/risk, previous COPD exacerbations, % predicted forced expiratory volume in 1 s, treatment arm and BMI.
Tables
- TABLE 1
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.
- TABLE 2
Total on- and post-treatment cause-specific mortality 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 Respiratory mortality Deaths (%) 24 (2.2%) 49 (1.1%) 27 (0.5%) 23 (0.7%) 8 (0.6%) 6 (1.0%) Hazard ratio (95% CI) 1.44 (0.86–2.41) Ref. 0.51 (0.32–0.81) 0.77 (0.46–1.30) 0.80 (0.37–1.72) 1.31 (0.54–3.16) Cardiovascular mortality Deaths (%) 41 (3.7%) 132 (3.1%) 119 (2.1%) 94 (2.7%) 35 (2.6%) 24 (4.1%) Hazard ratio (95% CI) 1.30 (0.90–1.87) Ref. 0.69 (0.53–0.88) 0.90 (0.68–1.19) 1.04 (0.71–1.53) 1.87 (1.19–2.94) Hazard ratio (95% CI) per Cox proportional hazards. Adjusted model accounts for age, sex, region, race, ischaemic heart disease indicator, vascular disease indicator, smoking status, cardiovascular entry criteria (history and risk by age), previous COPD exacerbations, % predicted forced expiratory volume in 1 s, treatment arm and BMI.
- TABLE 3
On-treatment system-specific morbidity by body mass index (BMI) categories
Underweight <20 kg·m−2 (n=1111) Normal 20– <25 kg·m−2 (n=4306) Overweight 25– <30 kg·m−2 (n=5662) Class I obesity 30– <35 kg·m−2 (n=3452) Class II obesity 35– <40 kg·m−2 (n=1367) Class III obesity ≥40 kg·m−2 (n=587) Moderate/severe COPD exacerbation# Events (%) 325 (29.3%) 1206 (28.0%) 1551 (27.4%) 1005 (29.1%) 429 (31.4%) 188 (32.0%) Hazard ratio (95% CI) 1.01 (0.89–1.14) Ref. 0.97 (0.90–1.05) 1.02 (0.93–1.11) 1.14 (1.01–1.28) 1.05 (0.89–1.23) Severe COPD exacerbation¶ Events (%) 128 (11.5%) 367 (8.5%) 384 (6.8%) 265 (7.7%) 105 (7.7%) 44 (7.5%) Hazard ratio (95% CI) 1.18 (0.96–1.46) Ref. 0.85 (0.73–0.98) 1.02 (0.87–1.21) 1.14 (0.90–1.43) 1.07 (0.77–1.49) Pneumonia Events (%) 106 (9.5%) 260 (6.0%) 235 (4.2%) 153 (4.4%) 58 (4.2%) 26 (4.4%) Hazard ratio (95% CI) 1.33(1.05–1.67) REF. 0.76 (0.63–0.91) 0.83(0.67–1.03) 0.84(0.62–1.14) 0.80(0.52–1.22) Composite cardiovascular events+ Events (%) 46 (4.1%) 191 (4.4%) 231 (4.1%) 154 (4.5%) 47 (3.4%) 19 (3.2%) Hazard ratio (95% CI) 1.01 (0.73–1.40) Ref. 0.90 (0.74–1.10) 0.98 (0.78–1.22) 0.88 (0.64–1.23) 0.93 (0.57–1.50) Hazard ratio (95% CI) per Cox proportional hazards. Adjusted model accounts for age, sex, region, race, ischaemic heart disease indicator, vascular disease indicator, smoking status, cardiovascular entry criteria (history and risk by age), previous COPD exacerbations, % predicted forced expiratory volume in 1 s, treatment arm and BMI. #: moderate COPD exacerbations were exacerbation treated with antibiotics and/or systemic corticosteroids; ¶: severe COPD exacerbations were those that required hospitalisation; +: composite cardiovascular events were predefined secondary end-points, contains myocardial infarction, stroke, transient ischaemic attack, unstable angina, and on-treatment cardiovascular death.
Supplementary Material
Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.
Supplementary material 00902-2020.SUPPLEMENT
