Table 3.
Number (%) of respondersa for selected efficacy variables at the study endpoint (full analysis set)
Placebo | Mirabegron OCASb | Tolterodine ERb | ||||
---|---|---|---|---|---|---|
25 mg | 50 mg | 100 mg | 200 mg | 4 mg | ||
Patients, n (%)c | ||||||
Micturitions/24 h* | n = 166 | n = 167 | n = 167 | n = 168 | n = 166 | n = 85 |
32 (19.3) | 48 (28.7) | 46 (27.5) | 55 (32.7) | 50 (30.1) | 16 (18.8) | |
Incontinence episodes/24 h* | n = 106 | n = 99 | n = 108 | n = 111 | n = 110 | n = 53 |
39 (36.8) | 42 (42.4) | 45 (41.7) | 62 (55.9) | 53 (48.2) | 19 (35.8) | |
Urgency episodes (grade ≥ 3)/24 h | n = 165 | n = 167 | n = 166 | n = 168 | n = 165 | n = 85 |
25 (15.2) | 27 (16.2) | 24 (14.5) | 33 (19.6) | 36 (21.8) | 13 (15.3) | |
Nocturia episodes/24 h | n = 144 | n = 145 | n = 142 | n = 141 | n = 147 | n = 72 |
21 (14.6) | 34 (23.4) | 34 (23.9) | 20 (14.2) | 34 (23.1) | 13 (18.1) |
OCAS oral controlled absorption system, ER extended release
*p ≤ 0.05 based on a Mantel–Haenszel test to compare all treatment groups, except tolterodine
aResponder definitions: micturitions, <8 micturitions/24 h; incontinence episodes, no episodes (patient became dry); urgency and nocturia episodes, no episodes of either
bMirabegron and tolterodine were administered once daily (QD)
cPercentages are based on the number of patients with available data at the endpoint