Table 1.
Baseline characteristics and demographics by fibrinogen subgroup at Week 16
| Characteristic | Fibrinogen population | ITT population | ||||||
|---|---|---|---|---|---|---|---|---|
| Quartile 1 n = 2017 < 2.780a |
Quartile 2 n = 2025 ≥ 2.780 to < 3.280a |
Quartile 3 n = 2002 ≥ 3.280 to < 3.830a |
Quartile 4 n = 2050 ≥ 3.830a |
< 3.5 g/L n = 5045 |
≥ 3.5 g/L n = 3049 |
Total N = 8094 |
Total N = 10,355 |
|
| Age, years, mean (SD) | 65.2 (8.4) | 65.0 (8.3) | 65.2 (8.2) | 65.5 (8.1) | 65.2 (8.3) | 65.3 (8.1) | 65.2 (8.2) | 65.3 (8.27) |
| Male, n (%) | 1516 (75) | 1345 (66) | 1269 (63) | 1356 (66) | 3503 (69) | 1983 (65) | 5846 (68) | 6870 (66) |
| BMI, kg/m2, mean (SD) | 25.4 (5.3) | 26.3 (5.8) | 27.2 (6.2) | 27.6 (6.6) | 26.1 (5.6) | 27.6 (6.6) | 26.6 (6.1) | 26.6 (6.1) |
| Smoking status, n (%) | ||||||||
| Current | 554 (27) | 676 (33) | 787 (39) | 785 (38) | 1614 (32) | 1188 (39) | 2802 (35) | 3587 (35) |
| Former | 1463 (73) | 1349 (67) | 1215 (61) | 1265 (62) | 3431 (68) | 1861 (61) | 5292 (65) | 6768 (65) |
| Lung function (post-bronchodilator) | ||||||||
| FEV1 (L), mean (SD) | 1.348 (0.4929) | 1.315 (0.4923) | 1.275 (0.4833) | 1.241 (0.4652) | 1.320 (0.4914) | 1.251 (0.4716) | 1.294 (0.4851) | 1.272 (0.4860) |
| FEV1% predicted, mean (SD) | 48.0 (14.9) | 46.8 (14.6) | 45.7 (14.8) | 44.4 (14.3) | 47.1 (14.8) | 44.7 (14.5) | 46.2 (14.7) | 45.5 (14.8) |
| FEV1/FVC ratio, mean (SD) | 0.472 (0.1185) | 0.475 (0.1187) | 0.474 (0.1193) | 0.473 (0.1192) | 0.473 (0.1182) | 0.475 (0.1201) | 0.474 (0.1189) | 0.470 (0.1196) |
| COPD exacerbations in previous year, n (%) | ||||||||
| Moderate | ||||||||
| 0 | 367 (18) | 370 (18) | 354 (18) | 397 (19) | 916 (18) | 572 (19) | 1488 (18) | 1936 (19) |
| 1 | 636 (32) | 701 (35) | 705 (35) | 696 (34) | 1681 (33) | 1057 (35) | 2738 (34) | 3542 (34) |
| ≥ 2 | 1014 (50) | 954 (47) | 943 (47) | 957 (47) | 2448 (49) | 1420 (47) | 3868 (48) | 4877 (47) |
| Moderate/severe | ||||||||
| 0 | 3 (< 1) | 1 (< 1) | 1 (< 1) | 1 (< 1) | 5 (< 1) | 1 (< 1) | 6 (< 1) | 9 (< 1) |
| 1 | 883 (44) | 909 (45) | 912 (46) | 925 (45) | 2247 (45) | 1382 (45) | 3629 (45) | 4691 (45) |
| ≥ 2 | 1131 (56) | 1115 (55) | 1089 (54) | 1124 (55) | 2793 (55) | 1666 (55) | 4459 (55) | 5655 (55) |
| Severe | ||||||||
| 0 | 1532 (76) | 1507 (74) | 1500 (75) | 1501 (73) | 3796 (75) | 2244 (74) | 6040 (75) | 7684 (74) |
| 1 | 423 (21) | 451 (22) | 438 (22) | 467 (23) | 1088 (22) | 691 (23) | 1779 (22) | 2300 (22) |
| ≥ 2 | 62 (3) | 67 (3) | 64 (3) | 82 (4) | 161 (3) | 114 (4) | 275 (3) | 371 (4) |
| Current medical conditions, n (%) | ||||||||
| Angina pectoris | 50 (2) | 75 (4) | 73 (4) | 80 (4) | 161 (3) | 117 (4) | 278 (3) | 342 (3) |
| Myocardial infarction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (< 1) |
| Cardiovascular risk factorsb, n (%) | ||||||||
| Angina pectoris | 111 (6) | 160 (8) | 147 (7) | 162 (8) | 346 (7) | 234 (8) | 580 (7) | 737 (7) |
| Previous myocardial infarction | 112 (6) | 117 (6) | 138 (7) | 166 (8) | 308 (6) | 225 (7) | 533 (7) | 681 (7) |
Quartile 1, fibrinogen value < 25th percentile; Quartile 2, fibrinogen value > 25th percentile and < median; Quartile 3, fibrinogen value ≥ median and < 75th percentile; Quartile 4, fibrinogen value ≥ 75th percentile
BMI body mass index, SD standard deviation
aFibrinogen level descriptor (g/L)
bRisk factors includes past and current events