Table 1.
Patient characteristics (safety analysis set).
| Variable | Initial daily dose of dabigatran etexilate |
Totala (n=6148) | |
|---|---|---|---|
| 220 mg (n=4560) | 300 mg (n=1473) | ||
| Age, years | 73.2±8.7 | 63.0±9.0 | 70.8±9.9 |
| <65 | 666 (14.6) | 791 (53.7) | 1467 (23.9) |
| 65–74 | 1747 (38.3) | 577 (39.2) | 2358 (38.4) |
| ≥75 | 2147 (47.1) | 105 (7.1) | 2323 (37.8) |
| ≥70 | 3295 (72.3) | 295 (20.0) | 3680 (59.9) |
| Women | 1697 (37.2) | 293 (19.9) | 2044 (33.2) |
| Creatinine clearance, mL/min | |||
| <30 | 28 (0.6) | 6 (0.4) | 38 (0.6) |
| 30–50 | 925 (20.3) | 37 (2.5) | 1006 (16.4) |
| 50< to <80 | 2314 (50.7) | 505 (34.3) | 2859 (46.5) |
| ≥80 | 1082 (23.7) | 854 (58.0) | 1953 (31.8) |
| Unknown | 211 (4.6) | 71 (4.8) | 292 (4.7) |
| mean±SD | 67.6±23.0 | 89.8±27.6 | 72.8±26.1 |
| CHADS2 score | |||
| 0 | 517 (11.3) | 309 (21.0) | 839 (13.6) |
| 1 | 1333 (29.2) | 561 (38.1) | 1923 (31.3) |
| 2 | 1237 (27.1) | 319 (21.7) | 1594 (25.9) |
| 3 | 731 (16.0) | 171 (11.6) | 919 (14.9) |
| 4 | 422 (9.3) | 63 (4.3) | 497 (8.1) |
| 5 | 139 (3.0) | 14 (1.0) | 156 (2.5) |
| 6 | 30 (0.7) | 0 (0.0) | 30 (0.5) |
| Unknown | 151 (3.3) | 36 (2.4) | 190 (3.1) |
| mean±SD | 1.9±1.3 | 1.4±1.1 | 1.8±1.3 |
| Previous history | |||
| Stroke/TIA | 924 (20.3) | 273 (18.5) | 1218 (19.8) |
| Myocardial infarction | 233 (5.1) | 46 (3.1) | 283 (4.6) |
| Hemorrhagic events | 243 (5.3) | 35 (2.4) | 289 (4.7) |
| Gastrointestinal hemorrhage | 66 (1.4) | 9 (0.6) | 77 (1.3) |
| Gastrointestinal disorder | 101 (2.2) | 37 (2.5) | 142 (2.3) |
| Comorbidity | |||
| Heart failure | 863 (18.9) | 215 (14.6) | 1105 (18.0) |
| Hypertension | 3070 (67.3) | 908 (61.6) | 4054 (65.9) |
| Diabetes mellitus | 925 (20.3) | 297 (20.2) | 1236 (20.1) |
| Liver function disorder | 445 (9.8) | 160 (10.9) | 612 (10.0) |
| Renal impairment | 1934 (42.4) | 279 (18.9) | 2279 (37.1) |
| Gastrointestinal disorder | 720 (15.8) | 154 (10.5) | 887 (14.4) |
| Concomitant use of antiplatelets | 508 (11.1) | 108 ( 7.3) | 635 (10.3) |
TIA: transient ischemic attack.
Values are number (%) or mean±standard deviation.
a
Including 115 patients who received other dose levels.