Table 1.
Patient demographics and baseline clinical characteristics by treatment group (FAS)
| Placebo (n = 1328) | Mirabegron 50 mg (n = 1324) | Mirabegron 100 mg (n = 890) | |
|---|---|---|---|
| Gender, n (%) | |||
| Male | 362 (27.3) | 382 (28.9) | 241 (27.1) |
| Female | 966 (72.7) | 942 (71.1) | 649 (72.9) |
| Age (years) | |||
| Mean (SD) | 59.2 (13.2) | 59.7 (12.6) | 59.8 (12.9) |
| Range | 20–95 | 21–91 | 19–90 |
| Race, n (%) | |||
| White | 1227 (92.4) | 1235 (93.3) | 838 (94.2) |
| Black or African American | 80 (6.0) | 61 (4.6) | 36 (4.0) |
| Asian | 13 (1.0) | 17 (1.3) | 8 (0.9) |
| Other | 8 (0.6) | 11 (0.8) | 8 (0.9) |
| BMI (kg/m2)* | |||
| Mean | 29.1 (6.3) | 29.0 (6.1) | 29.1 (6.1) |
| Range | 15.9–58.1 | 16.3–60.5 | 16.2–62.6 |
| Type of OAB, n (%) | |||
| Urgency incontinence | 442 (33.3) | 491 (37.1) | 297 (33.4) |
| Mixed | 415 (31.3) | 412 (31.1) | 271 (30.4) |
| Frequency | 471 (35.5) | 421 (31.8) | 322 (36.2) |
| Duration of OAB (months) | |||
| Mean (SD) | 86.3 (99.1) | 85.2 (93.1) | 88.3 (101.6) |
| Previous OAB drug, n (%) | |||
| Yes | 704 (53.0) | 688 (52.0) | 460 (51.7) |
| Reasons for previous OAB drug discontinuation, n (%)† | |||
| Insufficient effect | |||
| Yes | 466 (66.2) | 464 (67.4) | 296 (64.3) |
| No | 238 (33.8) | 224 (32.6) | 164 (35.7) |
| Poor tolerability | |||
| Yes | 185 (26.3) | 173 (25.1) | 113 (24.6) |
| No | 519 (73.7) | 515 (74.9) | 347 (75.4) |
| Mean number of incontinence episodes/24 h | |||
| Mean (SD) | 1.8 (2.5) | 1.8 (2.5) | 1.8 (2.4) |
| Range | 0–26 | 0–18 | 0–15 |
| Mean number of micturitions/24 h | |||
| Mean (SD) | 11.6 (3.1) | 11.7 (3.2) | 11.6 (3.0) |
| Range | 4–40 | 6–37 | 7–35 |
FAS, full analysis set; SD, standard deviation; BMI, body mass index; OAB, overactive bladder.
*
For BMI, placebo (n = 1327) and mirabegron 100 mg (n = 889).
†
Percentages are based on patients who had taken previous OAB medication. Patients could choose more than one reason for discontinuation.