Table 1.
Baseline characteristics (safety analysis set)
| Placebo (n = 442) | Mirabegron Total (n = 445) | |
|---|---|---|
| Female sex, n (%) | 324 (73.3) | 317 (71.2) |
| Age, mean ± SD | 71.9 ± 6.0 | 71.7 ± 5.5 |
| Age ≥75 years, n (%) | 124 (28.1) | 125 (28.1) |
| BMI, kg/m2, mean ± SD | 30.2 ± 6.4 | 29.7 ± 6.3 |
| Category, n (%) | ||
| <25 | 91 (20.6) | 108 (24.3) |
| ≥25–<30 | 150 (33.9) | 157 (35.3) |
| ≥30 | 201 (45.5) | 180 (40.4) |
| Ethnicity, n (%) | ||
| Not Hispanic or Latino | 395 (89.4) | 401 (90.1) |
| Hispanic or Latino | 43 (9.7) | 41 (9.2) |
| Unknown | 4 (0.9) | 3 (0.7) |
| Race, n (%) | ||
| White | 357 (80.8) | 348 (78.2) |
| Asian | 54 (12.2) | 59 (13.3) |
| Black or African American | 25 (5.7) | 33 (7.4) |
| Other | 6 (1.4) | 5 (1.1) |
| Country, n (%) | ||
| United States | 389 (88.0) | 385 (86.5) |
| Canada | 53 (12.0) | 60 (13.5) |
| Charlson Comorbidity Index score, mean ± SD | 2.3 (1.2) | 2.3 (1.2) |
| History of psychiatric disorders | ||
| Depression | 72 (16.3) | 81 (18.2) |
| Insomnia | 82 (18.6) | 57 (12.8) |
| Anxiety | 42 (9.5) | 59 (13.3) |
| Sleep disorder | 5 (1.1) | 6 (1.3) |
| Attention deficit/hyperactivity disorder | 4 (0.9) | 4 (0.9) |
| Libido decreased | 4 (0.9) | 4 (0.9) |
| Bipolar disorder | 3 (0.7) | 4 (0.9) |
| Nicotine dependence | 5 (1.1) | 1 (0.2) |
| Adjustment disorder with depressed mood | 2 (0.5) | 1 (0.2) |
| Initial insomnia | 0 | 2 (0.4) |
| Persistent depressive disorder | 0 | 2 (0.4) |
| Stress | 0 | 2 (0.4) |
| Major depression | 1 (0.2) | 1 (0.2) |
| Adjustment disorder | 0 | 1 (0.2) |
| Alcoholism | 0 | 1 (0.2) |
| Burnout syndrome | 0 | 1 (0.2) |
| Depressed mood | 0 | 1 (0.2) |
| Drug abuse | 0 | 1 (0.2) |
| Drug dependence | 0 | 1 (0.2) |
| Emotional disorder | 0 | 1 (0.2) |
| Mood swings | 0 | 1 (0.2) |
| Nervousness | 0 | 1 (0.2) |
| Post-traumatic stress disorder | 0 | 1 (0.2) |
| Premature ejaculation | 0 | 1 (0.2) |
| Anxiety disorder | 1 (0.2) | 0 |
| Claustrophobia | 1 (0.2) | 0 |
| Obsessive-compulsive disorder | 1 (0.2) | 0 |
| MoCA total scorea, n (%) | ||
| Category, n (%) | ||
| Normal (≥26) | 305 (69.3) | 310 (70.0) |
| Mild (18–25) | 103 (23.4) | 112 (25.3) |
| Moderate (10–17) | 3 (0.7) | 3 (0.7) |
| Severe (<10) | 0 | 0 |
| Missing | 29 (6.6) | 18 (4.1) |
Safety analysis set (SAF): all randomized subjects who received ≥1 dose of study medication
MoCA Montreal Cognitive Assessment, SD standard deviation
aN = 440 for placebo and 443 for mirabegron total