Table 2.
Male patient demographics and baseline characteristics (FAS).
| Pooled studies (SCORPIO/ARIES/CAPRICORN) |
TAURUS |
BEYOND |
||||
|---|---|---|---|---|---|---|
| Placebo (n = 362) | Mirabegron 50 mg (n = 382) | Mirabegron 50 mg (n = 204) | Tolterodine ER 4 mg (n = 206) | Mirabegron 50 mg (n = 222) | Solifenacin 5 mg (n = 221) | |
| Sex, n (% of total study population) | ||||||
| Male/total | 362/1328 (27.3) | 382/1324 (28.9) | 204/789 (25.9) | 206/791 (26.0) | 222/921 (24.1) | 221/912 (24.2) |
| Age, years | ||||||
| Mean (SD) | 62.1 (12.8) | 62.8 (11.3) | 61.6 (11.5) | 61.7 (12.0) | 58.1 (15.1) | 59.5 (14.6) |
| Range | 23–86 | 21–85 | 24–87 | 24–83 | 22–87 | 19–87 |
| Race | ||||||
| White | 329 (90.9) | 356 (93.2) | 194 (95.1) | 197 (95.6) | 220 (99.1) | 217 (98.2) |
| Black/African American | 25 (6.9) | 16 (4.2) | 7 (3.4) | 5 (2.4) | 0 | 1 (0.5) |
| Asian | 4 (1.1) | 8 (2.1) | 3 (1.5) | 2 (1.0) | 1 (0.5%) | 3 (1.4) |
| Other | 4 (1.1) | 2 (0.5) | 0 | 2 (1.0) | 1 (0.5) | 0 |
| BMI, kg/m2 | ||||||
| Mean (SD) | 28.6 (5.5) | 28.2 (4.8) | 28.1 (4.4) | 28.4 (4.8) | 27.1 (4.0) | 27.6 (4.0) |
| Range | 15.9–56.6 | 19.4–45.5 | 19.4–51.9 | 19.4–45.1 | 20–41 | 20–44 |
| Type of OAB, n (%) | ||||||
| Urgency incontinence | 130 (35.9) | 141 (36.9) | 76 (37.3) | 67 (32.5) | 74 (33.3) | 78 (35.3) |
| Mixed | 16 (4.4) | 30 (7.9) | 6 (2.9) | 12 (5.8) | 19 (8.6) | 14 (6.3) |
| Frequency | 216 (59.7) | 211 (55.2) | 122 (59.8) | 127 (61.7) | 129 (58.1) | 129 (58.4) |
| Use of α1-blocker at baseline | 78 (21.5) | 82 (21.5) | 40 (19.6) | 43 (20.9) | 45 (20.3) | 50 (22.6) |
| History of BPH†, n (%) | 147 (40.6) | 142 (37.2) | 84 (41.2) | 78 (37.9) | 73 (32.9) | 80 (36.2) |
| Duration of OAB, months | ||||||
| Mean (SD) | 66.9 (78.6) | 73.4 (86.7) | 77.9 (94.6) | 62.7 (56.6) | 55.7 (75.4) | 51.7 (68.0) |
| Range | 3−688 | 3−688 | 3−534 | 5−427 | 3.2−568.0 | 3.0−568.0 |
| Previous OAB drug, n (%) | ||||||
| Yes | 133 (36.7) | 153 (40.1) | 91 (44.6) | 96 (46.6) | 222 (100.0) | 221 (100.0) |
| Reasons for previous OAB drug discontinuation,‡ n (%) | ||||||
| Insufficient effect | ||||||
| Yes | 95 (71.4) | 108 (70.6) | 62 (68.1) | 60 (62.5) | 222 (100.0) | 221 (100.0) |
| No | 38 (28.6) | 45 (29.4) | 29 (31.9) | 36 (37.5) | 0 | 0 |
| Poor tolerability | ||||||
| Yes | 30 (22.6) | 29 (19.0) | 14 (15.4) | 22 (22.9) | 34 (15.3) | 43 (19.5) |
| No | 103 (77.4) | 124 (81.0) | 77 (84.6) | 74 (77.1) | 188 (84.7) | 178 (80.5) |
| Mean number of incontinence episodes/24 h (FAS)* | ||||||
| Mean (SD) | 0.9 (2.09) | 1.0 (1.97) | 0.7 (1.74) | 0.7 (1.80) | ||
| Range | 0–26 | 0–15 | 0–11 | 0–17 | ||
| Mean number of incontinence episodes/24 h (FAS-I) | (n = 154) | (n = 168) | (n = 77) | (n = 76) | (n = 58) | (n = 59) |
| Mean (SD) | 2.1 (2.77) | 2.2 (2.45) | 1.9 (2.41) | 1.9 (2.55) | 2.13 (1.85) | 2.31 (2.16) |
| Range | 0−26 | 0−15 | 0–11 | 0–17 | 0.3–6.7 | 0.3–7.7 |
| Mean number of micturitions/24 h | ||||||
| Mean (SD) | 11.7 (3.4) | 12.0 (3.4) | 11.4 (2.8) | 11.4 (3.0) | 11.8 (3.1) | 11.6 (2.4) |
| Range | 4–40 | 7–33 | 6–25 | 7–25 | 8–27 | 8–22 |
| Mean number of urgency episodes/24 h | ||||||
| Mean (SD) | 5.0 (3.2) | 5.4 (3.9) | 5.2 (3.5) | 4.8 (3.6) | 7.6 (4.9) | 7.3 (4.4) |
| Range | 0–15 | 0–33 | 1–18 | 1–19 | 1–27 | 1–22 |
In BEYOND, summaries for incontinence episodes are only for patients with baseline value >0 (i.e. FAS-I).
History of BPH was defined using the following selected preferred terms based on MedDRA version 9.1 for the pooled studies and TAURUS and MedDRA version 12.1 for the BEYOND study for medical history: BPH, prostatic obstruction, prostatism, benign neoplasm of prostate, prostatic adenoma, transurethral prostatectomy, prostatomegaly, nocturia, terminal dribbling, urine flow decreased, strangury, and urinary hesitation.
Patients could choose more than one reason for discontinuation.
BMI, body mass index; BPH, benign prostatic hyperplasia; ER, extended release; FAS, full analysis set; FAS-I, full analysis set-incontinence; OAB, overactive bladder; SD, standard deviation.