Table 1.
Eligible patients in Phase 2 from Latin America. Baseline characteristics by dabigatran dose group.
| Total Population | Dabigatran 150 mg BID | Dabigatran 110 mg BID | |
|---|---|---|---|
| Patients, n* | 378 | 202 | 176 |
| Age, mean (SD), years | 70.3 (10.8) | 66.0 (11.0) | 75.2 (8.3) |
| BMI, mean (SD), kg/m2 | 28.36 (5.01) | 29.44 (4.85) | 27.11 (4.92) |
| Sex, male, n (%) | 213 (56.3) | 122 (60.4) | 91 (51.7) |
| Type of AF, n (%) | |||
| Paroxysmal | 164 (43.4) | 83 (41.1) | 81 (46.0) |
| Persistent | 136 (36.0) | 82 (40.6) | 54 (30.7) |
| Permanent | 78 (20.6) | 37 (18.3) | 41 (23.3) |
| Categorization of AF, n (%) | |||
| Symptomatic | 113 (29.9) | 67 (33.2) | 46 (26.1) |
| Minimally symptomatic | 143 (37.8) | 82 (40.6) | 61 (34.7) |
| Asymptomatic | 122 (32.3) | 53 (26.2) | 69 (39.2) |
| Medical history, n (%) | |||
| Previous stroke | 31 (8.2) | 17 (8.4) | 14 (8.0) |
| MI | 32 (8.5) | 17 (8.4) | 15 (8.5) |
| Coronary artery disease | 44 (11.6) | 21 (10.4) | 23 (13.1) |
| Congestive heart failure | 118 (31.2) | 59 (29.2) | 59 (33.5) |
| History of hypertension | 293 (77.5) | 164 (81.2) | 129 (73.3) |
| Diabetes mellitus | 76 (20.1) | 47 (23.3) | 29 (16.5) |
| Prior bleeding | 20 (5.3) | 6 (3.0) | 14 (8.0) |
| Creatinine clearance, mean (SD), mL/min | 76.7 (31.6) | 88.1 (32.4) | 62.5 (23.8) |
| CHA2DS2-VASc, mean (SD) | 3.2 (1.4) | 2.9 (1.5) | 3.6 (1.3) |
| HAS-BLED score, mean (SD) | 1.2 (0.8) | 1.0 (0.9) | 1.4 (0.7) |
| Medications, n (%) | |||
| Antiplatelet* | 77 (20.4) | 44 (21.8) | 33 (18.8) |
| Other cardiovascular** | 351 (92.9) | 190 (94.1) | 161 (91.5) |
| PPI | 81 (21.4) | 50 (24.8) | 31 (17.6) |
Acronyms: AF, atrial fibrillation; BID, twice a day; BMI, body mass index; MI, myocardial infarction; PPI, proton pump inhibitor; SD, standard deviation.
*
Antiplatelet use on the baseline visit date.
**
Antihypertensive/heart failure and antiarrhythmic therapy.