Table 2.
Patient baseline characteristics
| Characteristics | HandiHaler®
|
Respimat®
|
Total
|
|||
|---|---|---|---|---|---|---|
| Placebo n=8,343 |
Tiotropium n=9,647 |
Placebo n=3,283 |
Tiotropium n=3,282 |
Placebo n=11,626 |
Tiotropium n=12,929 |
|
| Age, mean (SD), years | 64.63 (8.90) | 64.38 (8.76) | 64.73 (8.85) | 64.64 (8.94) | 64.66 (8.89) | 64.45 (8.80) |
| Male, n (%) | 6,327 (75.8) | 7,315 (75.8) | 2,429 (74.0) | 2,451 (74.7) | 8,756 (75.3) | 9,766 (75.5) |
| Current smoker, n (%) | 2,809 (33.7) | 3,329 (34.5) | 1,238 (37.7) | 1,233 (37.6) | 4,047 (34.8) | 4,562 (35.3) |
| Baseline spirometry, mean prebronchodilator (SD) | ||||||
| FEV1, L | 1.17 (0.46) | 1.18 (0.47) | 1.11 (0.41) | 1.11 (0.41) | 1.15 (0.45) | 1.16 (0.46) |
| FEV1, % predicted | 41.22 (14.20) | 41.66 (14.43) | 40.30 (12.45) | 40.11 (12.32) | 40.96 (13.73) | 41.27 (13.94) |
| FVC, L | 2.51 (0.82) | 2.49 (0.82) | 2.45 (0.79) | 2.45 (0.78) | 2.49 (0.81) | 2.48 (0.81) |
| FEV1/FVC | 0.47 (0.12) | 0.48 (0.13) | 0.46 (0.11) | 0.46 (0.11) | 0.47 (0.12) | 0.48 (0.12) |
| Baseline concomitant medicationa, n (%) | ||||||
| Any respiratory medication | 7,057 (84.6) | 8,021 (83.1) | 2,767 (84.3) | 2,784 (84.8) | 9,824 (84.5) | 10,805 (83.6) |
| SAMA | 3,295 (39.5) | 3,709 (38.4) | 982 (29.9) | 1,040 (31.7) | 4,277 (36.8) | 4,749 (36.7) |
| LAMA | 150 (1.8) | 150 (1.6) | 325 (9.9) | 313 (9.5) | 475 (4.1) | 463 (3.6) |
| β2 agonists | 6,199 (74.3) | 6,789 (70.4) | 2,440 (74.3) | 2,469 (75.2) | 8,639 (74.3) | 9,258 (71.6) |
| Short acting | 5,044 (60.5) | 5,630 (58.4) | 1,816 (55.3) | 1,815 (55.3) | 6,860 (59.0) | 7,445 (57.6) |
| Long acting | 3,340 (40.0) | 3,520 (36.5) | 1,538 (46.8) | 1,597 (48.7) | 4,878 (42.0) | 5,117 (39.6) |
| Steroids | 4,731 (56.7) | 5,379 (55.8) | 1,844 (56.2) | 1,821 (55.5) | 6,575 (56.6) | 7,200 (55.7) |
| ICS | 4,564 (54.7) | 5,184 (53.7) | 1,807 (55.0) | 1,785 (54.4) | 6,371 (54.8) | 6,969 (53.9) |
| OCS | 547 (6.6) | 635 (6.6) | 100 (3.0) | 100 (3.0) | 647 (5.6) | 735 (5.7) |
| ICS+LABA | 2,687 (32.2) | 2,904 (30.1) | 1,358 (41.4) | 1,395 (42.5) | 4,045 (34.8) | 4,299 (33.3) |
| Xanthines | 1,705 (20.4) | 2,103 (21.8) | 638 (19.4) | 667 (20.3) | 2,343 (20.2) | 2,770 (21.4) |
| Oxygen | 399 (4.8) | 414 (4.3) | 63 (1.9) | 54 (1.6) | 462 (4.0) | 468 (3.6) |
| Mucolytics | 411 (4.9) | 473 (4.9) | 228 (6.9) | 237 (7.2) | 639 (5.5) | 710 (5.5) |
| Other respiratory medication | 178 (2.1) | 196 (2.0) | 35 (1.1) | 46 (1.4) | 213 (1.8) | 242 (1.9) |
| Any CV medication | 4,599 (55.1) | 5,283 (54.8) | 1,690 (51.5) | 1,723 (52.5) | 6,289 (54.1) | 7,006 (54.2) |
| Cardiac disorder presentb, n (%) | 2,048 (25.8) | 2,257 (26.8) | 852 (26.0) | 891 (27.1) | 2,900 (25.8) | 3,148 (26.9) |
| Cardiac arrhythmia presentb, n (%) | 611 (7.7) | 719 (8.5) | 350 (10.7) | 428 (13.0) | 961 (8.6) | 1,147 (9.8) |
| Renal disorder presentb,c, n (%) | 127 (1.6) | 151 (1.8) | 54 (1.6) | 68 (2.1) | 181 (1.6) | 219 (1.9) |
Notes:
a
Includes patients with combination therapy.
b
Excluded study 205.257, for which diagnoses could not be mapped.
c
Listed as concomitant disease (any comorbidity at baseline coded to renal and/or urinary disorders).
Abbreviations: CV, cardiovascular; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity, ICS, inhaled corticosteroid; LABA, long-acting β2 agonist; LAMA, long-acting muscarinic antagonist; OCS, oral corticosteroid; SAMA, short-acting muscarinic antagonist; SD, standard deviation.