Table 1.
Baseline characteristics (safety analysis set)
| Characteristics | Placebo (n = 442) | Mirabegron | ||
|---|---|---|---|---|
| 25 mg (n = 226) | 50 mg (n = 219) | Total (n = 445) | ||
| Female sex | 324 (73.3) | 168 (74.3) | 149 (68.0) | 317 (71.2) |
| Age (years) | 71.9 ± 6.0 | 71.6 ± 5.8 | 71.7 ± 5.2 | 71.7 ± 5.5 |
| Age ≥ 75 years | 124 (28.1) | 66 (29.2) | 59 (26.9) | 125 (28.1) |
| BMI (kg/m2) | 30.2 ± 6.4 | 29.2 ± 6.0 | 30.1 ± 6.6 | 29.7 ± 6.3 |
| Category | ||||
| < 25 | 91 (20.6) | 60 (26.5) | 48 (21.9) | 108 (24.3) |
| ≥ 25 to < 30 | 150 (33.9) | 84 (37.2) | 73 (33.3) | 157 (35.3) |
| ≥ 30 | 201 (45.5) | 82 (36.3) | 98 (44.7) | 180 (40.4) |
| Race | ||||
| White | 357 (80.8) | 151 (66.8) | 197 (90.0) | 348 (78.2) |
| Black or African American | 25 (5.7) | 16 (7.1) | 17 (7.8) | 33 (7.4) |
| Asian | 54 (12.2) | 58 (25.7) | 1 (0.5) | 59 (13.3) |
| Other | 6 (1.4) | 1 (0.4) | 4 (1.8) | 5 (1.1) |
| Country | ||||
| USA | 389 (88.0) | 215 (95.1) | 170 (77.6) | 385 (86.5) |
| Canada | 53 (12.0) | 11 (4.9) | 49 (22.4) | 60 (13.5) |
| Medical history, most frequent conditionsa | ||||
| Hypertension | 243 (55.0) | 134 (59.3) | 125 (57.1) | 259 (58.2) |
| Osteoarthritis | 173 (39.1) | 60 (26.5) | 87 (39.7) | 147 (33.0) |
| Hypertonic bladderb | 145 (32.8) | 86 (38.1) | 72 (32.9) | 158 (35.5) |
| Gastroesophageal reflux disease | 135 (30.5) | 54 (23.9) | 77 (35.2) | 131 (29.4) |
| Concomitant non-OAB medications, most frequent | ||||
| Vitamins | 208 (47.1) | 95 (42.0) | 114 (52.1) | 209 (47.0) |
| Analgesics | 201 (45.5) | 100 (44.2) | 110 (50.2) | 210 (47.2) |
| Lipid-modifying agents | 190 (43.0) | 93 (41.2) | 99 (45.2) | 192 (43.1) |
Data are presented as mean ± standard deviation or N (%) unless otherwise indicated. Safety analysis set: all randomized subjects who received one or more dose of study medication. Reprinted from Wagg et al. [19] with permission from Elsevier
BMI body mass index, OAB overactive bladder
aBy preferred term
bWorsening OAB