Table 2.
Parameter | Nitti et al43 | Khullar et al44 | Van Kerrebroeck et al45 | ||||
---|---|---|---|---|---|---|---|
|
|
|
|||||
Placebo | Mirabegron 50 mg | Placebo | Mirabegron 50 mg | Placebo | Mirabegron 25 mg | Mirabegron 50 mg | |
Micturitions per 24 hours (n) | |||||||
n | 480 | 473 | 433 | 425 | 415 | 410 | 426 |
Baseline (mean) | 11.71 | 11.65 | 11.51 | 11.80 | 11.48 | 11.68 | 11.66 |
Change from baseline (adjusted mean)† | −1.34 | −1.93 | −1.05 | −1.66 | −1.18 | −1.65 | −1.60 |
Difference from placebo (adjusted mean)† | – | −0.60 | – | −0.61 | – | −0.47 | −0.42 |
95% confidence interval | – | (−0.90, −0.29) | – | (−0.98, −0.24) | – | (−0.82, −0.13) | (−0.76, −0.08) |
P value | <0.001# | 0.001# | 0.007# | 0.015# |
Notes:
Week 12 is last observation on treatment;
least squares mean adjusted for baseline, gender, and geographical region; ^for incontinence episodes per 24 hours, the analysis population is restricted to patients with at least one episode of incontinence at baseline;
statistically significantly superior compared with placebo at the 0.05 level with multiplicity adjustment. Data from Mirabegron prescribing information.48