Table 1.
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 | |
Incontinence episodes per 24 hours (n)^ | |||||||
n | 291 | 293 | 325 | 312 | 262 | 254 | 257 |
Baseline (mean) | 2.67 | 2.83 | 3.03 | 2.77 | 2.43 | 2.65 | 2.51 |
Change from baseline (adjusted mean)† | −1.17 | −1.57 | −1.13 | −1.47 | −0.96 | −1.36 | −1.38 |
Difference from placebo (adjusted mean)† | – | −0.41 | – | −0.34 | – | −0.40 | −0.42 |
95% confidence interval | – | (−0.72, −0.09) | – | (−0.66, −0.03) | – | (−0.74, −0.06) | (−0.76, −0.08) |
P value | 0.003# | 0.026# | 0.005# | 0.001# |
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 to placebo at the 0.05 level with multiplicity adjustment. Data from Mirabegron prescribing information.48