Table 2.
Patients’ baseline and demographic characteristics and coexisting cardiovascular risk factorsa
| IND 75 n = 449 |
IND 150 n = 2611 |
IND 300 n = 1157 |
IND 600 n = 547 |
FOR n = 556 |
SLM n = 895 |
TIO n = 1214 |
PBO n = 2012 |
|
|---|---|---|---|---|---|---|---|---|
| Age (%) | ||||||||
| <65 years | 53.2 | 52.5 | 49.6 | 53.4 | 50.7 | 53.7 | 54.0 | 52.3 |
| 65–<75 years | 34.1 | 36.0 | 37.5 | 36.4 | 36.9 | 35.4 | 35.8 | 36.8 |
| ≥75 years | 12.7 | 11.5 | 12.9 | 10.2 | 12.4 | 10.8 | 10.3 | 10.9 |
| Males (%) | 55.2 | 69.5 | 78.5 | 73.3 | 75.2 | 74.2 | 66.5 | 71.4 |
| Race (%) | ||||||||
| Caucasian | 92.2 | 77.6 | 66.7 | 92.0 | 91.9 | 82.2 | 91.4 | 74.7 |
| Black | 4.2 | 2.1 | 1.1 | 1.1 | 0.5 | 1.2 | 1.5 | 1.9 |
| Asian | 2.5 | 17.7 | 30.1 | 2.7 | 2.3 | 13.4 | 4.3 | 20.6 |
| Other | 1.1 | 2.6 | 2.1 | 4.2 | 5.2 | 3.1 | 2.8 | 2.8 |
| Severity of COPD (%) | ||||||||
| GOLD stage II or less | 63.0 | 58.7 | 55.7 | 55.8 | 55.6 | 55.0 | 59.9 | 55.2 |
| GOLD stage III or worse | 37.0 | 41.3 | 44.3 | 44.1 | 43.9 | 45.0 | 40.1 | 44.7 |
| ICS use (current) (%) | 41.7 | 43.6 | 42.4 | 48.8 | 50.4 | 45.9 | 48.5 | 41.0 |
| Ex/current smoker (%) | 52.1/47.9 | 56.5/43.5 | 60.9/39.5 | 58.7/41.3 | 59.2/40.8 | 55.2/44.8 | 55.7/44.3 | 57.1/42.9 |
| Pack-years (mean [SD]) | 53.9 (26.82) | 44.5 (22.69) | 48.4 (33.21) | 53.0 (60.43) | 49.8 (54.60) | 43.2 (21.88) | 44.6 (22.09) | 49.0 (42.03) |
| No. of CV risk factorsa (%) | ||||||||
| 0 | 3.3 | 7.1 | 9.0 | 6.8 | 7.9 | 6.7 | 6.7 | 7.2 |
| 1 | 17.4 | 23.2 | 27.4 | 25.6 | 23.2 | 26.9 | 21.6 | 26.6 |
| 2 | 31.0 | 28.2 | 28.4 | 28.0 | 28.4 | 25.3 | 29.4 | 26.4 |
| 3 or more | 48.3 | 41.5 | 35.2 | 39.7 | 40.5 | 41.1 | 42.3 | 39.8 |
| Concomitant CCV condition | 22.5 | 18.2 | 16.9 | 20.8 | 20.5 | 20.2 | 19.9 | 19.0 |
a
Note: CV risk factors were: age ≥65, current smoker, CCV condition, hypertension, hyperlipidemia, diabetes mellitus, and body mass index >30 kg/m2 at baseline.
Abbreviations: IND, indacaterol; FOR, formoterol; SLM, salmeterol; TIO, tiotropium; PBO, placebo; COPD, chronic obstructive pulmonary disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroids; CV, cardiovascular; CCV, cardio- or cerebrovascular; n, number.