Table 3.
Variable | Population | Mirabegron | Tolterodine | Period-by-treatment interaction p value | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
No. of patients | Baseline, mean (SE) | EoT, mean (SE) | Adjusted change from baseline to EoT, mean (SE), [95% CI] | No. of patients | Baseline, mean (SE) | EoT, mean (SE) | Adjusted change from baseline to EoT, mean (SE), [95% CI] | Adjusted difference vs. mirabegron, mean (SE) [95% CI] | |||
Incontinence episodes/24h | FAS-I | 248 | 3.70 (0.29) [n = 245] | 2.07 (0.25) [n=246] | –1.51 (0.19) [−1.89, −1.13] | 240 | 3.69 (0.30) [n=238] | 2.02 (0.23) [n=235] | −1.46 (0.19) (−1.84, −1.07) | 0.05 (0.224) [−0.39, 0.49] | 0.971 |
Number of micturitions/24h | FAS | 341 | 10.34 (0.18) [n=336] | 8.25 (0.18) [n=336] | –2.06 (0.19) [−2.44, −1.68] | 336 | 10.08 (0.21) [n=334] | 8.13 (0.19) [n=329] | −1.95 (0.20) [−2.33, −1.57] | 0.11 (0.20) [−0.28, 0.50] | 0.211 |
Urgency incontinence episodes/24h | FAS-I | 248 | 3.20 (0.28) [n=245] | 1.61 (0.22) [n=246] | –1.42 (0.20) [−1.81, −1.02] | 240 | 3.16 (0.28) [n=238] | 1.55 (0.21) [n=235] | −1.37 (0.20) [−1.76, −0.97] | 0.05 (0.20) [−0.35, 0.45] | |
Number of urgency episodes (PPIUS grade 3 or 4)/24h | FAS | 341 | 4.39 (0.24) [n=336] | 2.14 (0.19) [n=336] | –2.26 (0.19) [−2.64, −1.88] | 336 | 4.23 (0.24) [n=334] | 2.13 (0.19) [n=329] | −2.13 (0.19) [−2.51, −1.75] | 0.13 (0.17) [−0.20, 0.46] | |
Number of nocturia episodes/24h | FAS | 341 | 1.62 (0.06) [n=277] | 1.27 (0.06) [n=272] | –0.26 (0.06) (−0.38, −0.14) | 336 | 1.47 (0.06) [n=280] | 1.22 (0.05) [n=273] | −0.25 (0.06) (−0.37, −0.13) | 0.01 (0.07) [−0.13, 0.15] |
FAS Full analysis set, FAS-I Full analysis set–incontinence