Table 1.
Patient demographics and baseline characteristics
| Characteristic | Total study population, N=8,061 | Index on-treatment exacerbation
|
|||
|---|---|---|---|---|---|
| Moderate
|
Severe (requiring hospitalization), N=1,490 | ||||
| Treated with antibiotics only, N=3,080 | Treated with systemic corticosteroids only, N=821 | Treated with antibiotics and systemic corticosteroids, N=2,670 | |||
| Males, n (%) | 5,463 (67.8) | 2,091 (67.9) | 564 (68.7) | 1,667 (62.4) | 1,141 (76.6) |
| Age, years, mean (SD) | 65.2 (9.0) | 64.7 (8.9) | 65.5 (9.2) | 65.2 (9.0) | 66.2 (9.0) |
| BMI, kg/m2, mean (SD) | 26.1 (5.8) | 26.4 (5.6) | 25.9 (5.7) | 26.2 (5.8) | 25.4 (6.1) |
| BMI category, n (%) | |||||
| <18.5 kg/m2 | 564 (7.0) | 178 (5.8) | 52 (6.3) | 182 (6.8) | 152 (10.2) |
| 18.5 to <25 kg/m2 | 3,175 (39.4) | 1,135 (36.9) | 352 (42.9) | 1,020 (38.2) | 668 (44.8) |
| 25 to <30 kg/m2 | 2,537 (31.5) | 1,066 (34.6) | 250 (30.5) | 853 (31.9) | 368 (24.7) |
| ≥30 kg/m2 | 1,785 (22.1) | 701 (22.8) | 167 (20.3) | 615 (23.0) | 302 (20.3) |
| Region, n (%) | |||||
| Euro/Africa/Aus/NZ | 4,342 (53.9) | 1,842 (59.8) | 427 (52.0) | 1,284 (48.1) | 789 (53.0) |
| Latin America | 539 (6.7) | 168 (5.5) | 82 (10.0) | 230 (8.6) | 59 (4.0) |
| North America | 2,227 (27.6) | 721 (23.4) | 217 (26.4) | 958 (35.9) | 331 (22.2) |
| Asia | 953 (11.8) | 349 (11.3) | 95 (11.6) | 198 (7.4) | 311 (20.9) |
| Duration of COPD, years, mean (SD) | 7.9 (6.2) | 7.7 (6.3) | 7.9 (6.1) | 8.1 (6.2) | 7.7 (6.0) |
| Smoking history, pack-years, mean (SD)a | 44.7 (25.3) | 43.0 (23.7) | 45.0 (26.0) | 46.1 (26.2) | 45.2 (26.3) |
| No of COPD episodes treated in the last year, mean (SD) | 1.0 (1.3) | 1.0 (1.3) | 0.9 (1.3) | 1.1 (1.4) | 1.1 (1.3) |
| No of COPD episodes treated in the last year, n (%)a | |||||
| 0 | 3,561 (44.2) | 1,409 (45.7) | 407 (49.6) | 1,172 (43.9) | 573 (38.5) |
| 1 | 2,437 (30.2) | 934 (30.3) | 229 (27.9) | 772 (28.9) | 502 (33.7) |
| 2 | 1,186 (14.7) | 435 (14.1) | 109 (13.3) | 404 (15.1) | 238 (16.0) |
| 3 | 512 (6.4) | 174 (5.6) | 43 (5.2) | 185 (6.9) | 110 (7.4) |
| 4 | 194 (2.4) | 74 (2.4) | 16 (1.9) | 73 (2.7) | 31 (2.1) |
| ≥5 | 164 (2.0) | 51 (1.7) | 16 (1.9) | 62 (2.3) | 35 (2.3) |
| Postbronchodilator spirometry, mean (SD)a | |||||
| FEV1, L | 1.265 (0.459) | 1.354 (0.469) | 1.248 (0.450) | 1.249 (0.446) | 1.119 (0.420) |
| FEV1, % predicted | 46.4 (13.9) | 48.9 (13.7) | 45.7 (13.8) | 46.3 (13.6) | 41.7 (13.7) |
| FVC, L | 2.649 (0.832) | 2.758 (0.842) | 2.634 (0.854) | 2.624 (0.812) | 2.477 (0.800) |
| Ratio of FEV1 to FVC | 0.484 (0.115) | 0.497 (0.113) | 0.482 (0.121) | 0.482 (0.115) | 0.459 (0.114) |
| GOLD stage, n (%)a | |||||
| I/II | 3,410 (42.3) | 1,543 (50.1) | 327 (39.8) | 1,097 (41.1) | 443 (29.7) |
| III | 3,478 (43.1) | 1,205 (39.1) | 359 (43.7) | 1,201 (45.0) | 713 (47.9) |
| IV | 1,074 (13.3) | 292 (9.5) | 123 (15.0) | 337 (12.6) | 322 (21.6) |
| Cardiac history | 2,171 (26.9) | 825 (26.8) | 184 (22.4) | 677 (25.4) | 485 (32.6) |
| Previous cardiac arrhythmia, n (%) | 909 (11.3) | 348 (11.3) | 83 (10.1) | 298 (11.2) | 180 (12.1) |
| Previous MI, n (%) | 515 (6.4) | 181 (5.9) | 44 (5.4) | 181 (6.8) | 109 (7.3) |
| Previous stroke, n (%) | 177 (2.2) | 64 (2.1) | 18 (2.2) | 53 (2.0) | 42 (2.8) |
| Previous IHD or CAD, n (%) | 1,225 (15.2) | 483 (15.7) | 106 (12.9) | 354 (13.3) | 282 (18.9) |
| History of heart failure, n (%)a | |||||
| None | 7,453 (92.5) | 2,856 (92.7) | 779 (94.9) | 2,530 (94.8) | 1,288 (86.4) |
| Class I | 222 (2.8) | 82 (2.7) | 13 (1.6) | 57 (2.1) | 70 (4.7) |
| Class II | 321 (4.0) | 120 (3.9) | 25 (3.0) | 65 (2.4) | 111 (7.4) |
| Class III | 55 (0.7) | 17 (0.6) | 3 (0.4) | 16 (0.6) | 19 (1.3) |
| Class IV | 3 (0.0) | 1 (0.0) | 1 (0.1) | 0 (0.0) | 1 (0.1) |
| Taking CV medication, n (%) | 4,204 (52.2) | 1,610 (52.3) | 421 (51.3) | 1,416 (53.0) | 757 (50.8) |
| Taking respiratory medication, n (%)a | 7,620 (94.5) | 2,853 (92.6) | 793 (96.6) | 2,561 (95.9) | 1,413 (94.8) |
| ICS only | 438 (5.4) | 134 (4.4) | 52 (6.3) | 159 (6.0) | 93 (6.2) |
| LABA only | 355 (4.4) | 159 (5.2) | 34 (4.1) | 104 (3.9) | 58 (3.9) |
| LAMA only | 741 (9.2) | 323 (10.5) | 79 (9.6) | 216 (8.1) | 123 (8.3) |
| LABA+ICS only | 1,852 (23.0) | 693 (22.5) | 185 (22.5) | 620 (23.2) | 354 (23.8) |
| ICS+LABA+LAMA | 2,924 (36.3) | 1,041 (33.8) | 292 (35.6) | 1,038 (38.9) | 553 (37.1) |
Notes: Percentages shown are “column” percentages.
a
Patients with missing data were excluded.
Abbreviations: Aus, Australia; BMI, body mass index; CAD, coronary artery disease; CV, cardiovascular; Euro, Europe; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; IHD, ischemic heart disease; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; MI, myocardial infarction; NZ, New Zealand.