Table 1.
Baseline characteristics* of patients according to treatment allocation (tiotropium or placebo)
|
Discontinued |
Not discontinued |
|||||
|---|---|---|---|---|---|---|
| Placebo | Tiotropium | Total | Placebo | Tiotropium | Total | |
| Number of patients (%) | 2783 (100.0) | 3063 (100.0) | 5846 (100.0) | 3085 (100.0) | 3232 (100.0) | 6317 (100.0) |
| Age, years | 66.1 (8.6) | 66.1 (8.4) | 66.1 (8.5) | 64.6 (9.0) | 64.4 (8.8) | 4.5 (8.9) |
| Gender, n (%) | ||||||
| Female | 577 (20.7) | 623 (20.3) | 1200 (20.5) | 712 (23.1) | 762 (23.6) | 1474 (23.3) |
| Male | 2206 (79.3) | 2440 (79.7) | 4646 (79.5) | 2373 (76.9) | 2470 (76.4) | 4843 (76.7) |
| Smoking history, n (%) | ||||||
| Exsmoker | 1972 (70.9) | 2176 (71.0) | 4148 (71.0) | 2084 (67.6) | 2193 (67.9) | 4277 (67.7) |
| Never smoked | 1 (0.0) | 0 (0.0) | 1 (0.0) | 1 (0.0) | 0 (0.0) | 1 (0.0) |
| Smoker | 809 (29.1) | 887 (29.0) | 1696 (29.0) | 1000 (32.4) | 1038 (32.1) | 2038 (32.3) |
| Missing | 1 (0.0) | 0 (0.0) | 1 (0.0) | 0 (0.0) | 1 (0.0) | 1 (0.0) |
| Smoking history, pack-years | 55.6 (32.3) | 55.5 (30.9) | 55.6 (31.6) | 47.6 (27.5) | 48.8 (26.7) | 48.2 (26.6) |
| BMI | 26.3 (5.5) | 26.4 (5.5) | 26.4 (5.5) | 26.2 (5.3) | 26.3 (5.3) | 26.2 (5.3) |
| FEV1, % predicted† | 36.0 (12.4) | 35.7 (12.3) | 35.8 (12.4) | 42.0 (12.6) | 42.7 (12.8) | 42.3 (12.7) |
| FEV1/FVC† | 0.43 (0.11) | 0.43 (0.11) | 0.43 (0.11) | 0.47 (0.12) | 0.48 (0.12) | 0.48 (0.12) |
| GOLD stage, n (%) | ||||||
| I | 1 (0.0) | 0 (0.0) | 1 (0.0) | 1 (0.0) | 7 (0.2) | 8 (0.1) |
| II | 436 (15.7) | 444 (14.5) | 880 (15.1) | 873 (28.3) | 964 (29.8) | 1837 (29.1) |
| III | 1351 (48.5) | 1509 (49.3) | 2860 (48.9) | 1614 (52.3) | 1662 (51.4) | 3276 (51.9) |
| IV | 966 (34.7) | 1077 (35.2) | 2043 (34.9) | 554 (18.0) | 548 (17.0) | 1102 (17.4) |
| Missing | 29 (1.0) | 33 (1.1) | 62 (1.1) | 43 (1.4) | 51 (1.6) | 94 (1.5) |
| Receiving systemic corticosteroids, n (%) | 295 (10.6) | 283 (9.2) | 578 (9.9) | 137 (4.4) | 145 (4.5) | 282 (4.5) |
Mean (SD) unless otherwise specified. No BMI data available for study 205.214 because weights were not collected;
prebronchodilator values. GOLD based on prebronchodilator values: Stage I = mild (FEV1 ≥ 80% predicted); Stage II = moderate (FEV1 < 80% to ≥50% predicted); Stage III = severe (FEV1 < 50% to ≥30% predicted); Stage IV = very severe (FEV1 < 30% predicted). “Not discontinued” means either “not discontinued from anticholinergics” or “never took anticholinergics”.
Abbreviations: BMI, body mass index; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SD, standard deviation.