Table 1 Demographic and baseline characteristics (SAF) and OAB history (FAS), by treatment group
Placebo | Mirabegron | Mirabegron | Tolterodine | |
|---|---|---|---|---|
50 mg | 100 mg | ER 4 mg | ||
SAF | ||||
Patients, n | 494 | 493 | 496 | 495 |
Sex, n (%) | ||||
Female | 356 (72.1) | 357 (72.4) | 355 (71.6) | 361 (72.9) |
Age group, n (%) | ||||
≥65 years | 181 (36.6) | 178 (36.1) | 183 (36.9) | 192 (38.8) |
≥75 years | 44 (8.9) | 46 (9.3) | 46 (9.3) | 37 (7.5) |
Age, mean (SD) | 59.2 (12.3) | 59.1 (12.4) | 59.0 (12.7) | 59.1 (12.9) |
Race, n (%) | ||||
Caucasian | 490 (99.2) | 488 (99.0) | 492 (99.2) | 490 (99.0) |
Body mass index, kg/m2, mean (SD) | 27.8 (5.0) | 27.5 (4.9) | 28.0 (5.0) | 27.8 (5.0) |
FAS | ||||
Patients, n | 480 | 473 | 478 | 475 |
Type of OAB, n (%)* | ||||
Urgency incontinence | 201 (41.9) | 192 (40.6) | 179 (37.4) | 184 (38.7) |
Frequency | 177 (36.9) | 173 (36.6) | 183 (38.3) | 186 (39.2) |
Mixed | 102 (21.3) | 108 (22.8) | 116 (24.3) | 105 (22.1) |
Previous OAB medication | ||||
Yes (any, n [% of FAS]) | 238 (49.6) | 240 (50.7) | 237 (49.6) | 231 (48.6) |
Solifenacin, n (%)† | 127 (53.4) | 107 (44.6) | 112 (47.3) | 109 (47.2) |
Oxybutynin | 77 (32.4) | 82 (34.2) | 82 (34.6) | 79 (34.2) |
Tolterodine | 69 (29.0) | 59 (24.6) | 71 (30.0) | 58 (25.1) |
Trospium | 44 (18.5) | 45 (18.8) | 41 (17.3) | 49 (21.2) |
Propiverine | 22 (9.2) | 23 (9.6) | 16 (6.8) | 17 (7.4) |
Darifenacin | 14 (5.9) | 8 (3.3) | 21 (8.9) | 12 (5.2) |
Fesoterodine | 4 (1.7) | 1 (0.4) | 2 (0.8) | 2 (0.9) |
Reason for previous OAB medication discontinuation, n (%)†,‡ | ||||
Insufficient effect | 159 (66.8) | 160 (66.7) | 159 (67.1) | 155 (67.1) |
Poor tolerability | 68 (28.6) | 65 (27.1) | 64 (27.0) | 56 (24.2) |
Insufficient effect and poor tolerability | 26 (10.9) | 28 (11.7) | 31 (13.1) | 25 (10.8) |