Table 2.
Baseline Demographics and Characteristics
Eptinezumab 100 mg | Eptinezumab 300 mg | Eptinezumab 1000 mg | Placebo | |
---|---|---|---|---|
N = 701 | N = 695 | N = 81 | N = 791 | |
Mean age, years (SD) | 39.9 (11.11) | 40.1 (10.84) | 38.6 (10.81) | 39.3 (10.96) |
Sex: Female, n (%) | 590 (84.2) | 611 (87.9) | 67 (82.7) | 686 (86.7) |
Race, n (%) | ||||
White | 636 (90.7) | 623 (89.6) | 66 (81.5) | 677 (85.6) |
Black / African American | 50 (7.1) | 54 (7.8) | 10 (12.3) | 84 (10.6) |
Asian | 2 (0.3) | 3 (0.4) | 4 (4.9) | 7 (0.9) |
American Indian / Alaska Native | 1 (0.1) | 3 (0.4) | 0 | 3 (0.4) |
Native Hawaiian / other Pacific Islander | 1 (0.1) | 2 (0.3) | 0 | 2 (0.3) |
Multiple races | 9 (1.3) | 8 (1.2) | 1 (1.2) | 13 (1.6) |
Other | 2 (0.3) | 1 (0.1) | 0 | 5 (0.6) |
Not reported | 0 | 1 (0.1) | 0 | 0 |
Mean BMI, kg/m2 | 27.6 (6.15) | 27.3 (5.91) | 27.5 (5.17) | 27.9 (6.14) |
Preventive migraine medication use, n (%)* | 52/478 (10.9) | 62/471 (13.2) | – | 49/487 (10.1) |
Cardiovascular risk factors, n (%) | ||||
Hypertension-related | 36 (5.1) | 26 (3.7) | 1 (1.2) | 28 (3.5) |
Hyperlipidemia-related | 48 (6.8) | 45 (6.5) | 5 (6.2) | 45 (5.7) |
Diabetes-related | 3 (0.4) | 0 | 1 (1.2) | 5 (0.6) |
History of ischemic CV events/procedures | 4 (0.6) | 3 (0.4) | 0 | 3 (0.4) |
Obesity (Class 1 or 2), BMI ≥30 kg/m2 | 226 (32.2) | 197 (28.3) | 26 (32.1) | 265 (33.5) |
Male ≥45 years | 43 (6.1) | 24 (3.5) | 4 (4.9) | 38 (4.8) |
Female ≥55 years | 63 (9.0) | 57 (8.2) | 2 (2.5) | 49 (6.2) |
Black or African American race | 50 (7.1) | 54 (7.8) | 10 (12.3) | 84 (10.6) |
≥ 1 CV risk factor | 350 (49.9) | 316 (45.5) | 41 (50.6) | 382 (48.3) |
≥ 2 CV risk factors | 97 (13.8) | 83 (11.9) | 7 (8.6) | 112 (14.2) |
Medical/Surgical CV history, n (%) | ||||
Angina pectoris | 0 | 1 (0.1) | 0 | 0 |
Aortic valve incompetence | 1 (0.1) | 0 | 0 | 0 |
Arrhythmia | 0 | 0 | 1 (1.2) | 1 (0.1) |
Supraventricular arrhythmia | 0 | 1 (0.1) | 0 | 0 |
Atrioventricular block, first degree | 0 | 0 | 0 | 1 (0.1) |
Bradycardia | 2 (0.3) | 4 (0.6) | 0 | 4 (0.5) |
Bundle branch block, left | 1 (0.1) | 0 | 0 | 0 |
Bundle branch block, right | 0 | 2 (0.3) | 0 | 2 (0.3) |
Cardiomegaly | 1 (0.1) | 0 | 0 | 0 |
Cardiomyopathy | 0 | 1 (0.1) | 0 | 0 |
Mitral valve incompetence | 1 (0.1) | 0 | 0 | 1 (0.1) |
Mitral valve prolapse | 1 (0.1) | 4 (0.6) | 0 | 6 (0.8) |
Palpitations | 3 (0.4) | 2 (0.3) | 0 | 5 (0.6) |
POTS | 1 (0.1) | 0 | 0 | 0 |
Sinus arrhythmia | 1 (0.1) | 1 (0.1) | 0 | 0 |
Sinus bradycardia | 0 | 0 | 0 | 2 (0.3) |
Sinus tachycardia | 1 (0.1) | 1 (0.1) | 0 | 1 (0.1) |
Supraventricular tachycardia | 1 (0.1) | 2 (0.3) | 0 | 1 (0.1) |
Tachycardia | 0 | 2 (0.3) | 1 (1.2) | 5 (0.6) |
Tricuspid valve incompetence | 1 (0.1) | 0 | 0 | 0 |
Ventricular extrasystoles | 1 (0.1) | 0 | 0 | 1 (0.1) |
Ventricular tachycardia | 0 | 0 | 0 | 1 (0.1) |
*Use of a stable preventive migraine medication regimen was permitted in CM studies, and as such, the number of patients reflects only those studies. BMI body mass index, CM Chronic migraine, CV Cardiovascular, POTS Postural orthostatic tachycardia syndrome, SD Standard deviation