Mirabegron, a novel, non-antimuscarinic drug for the overactive bladder: An up-to-dated review

Table 1 Coprimary efficacy variables in 12-wk phase III pivotal randomized controlled trials

Trials	Patients (n)	Arms (n)	Change from baseline in incontinence episodes/d1 (FAS-I)	Change from baseline in micturitions/d1 (FAS)	Ref.
SCORPIO	1978	Placebo (494)	-1.17	-1.34	[50]
		Mirabegron 50 mg (493)	-1.57a	-1.93a
		Mirabegron 100 mg (496)	-1.46a	-1.77a
		Tolterodine 4 mg ER (495)	-1.27 (NS)	-1.59 (NS)
ARIES	1328	Placebo (454)	-1.13	-1.05	[51]
		Mirabegron 50 mg (442)	-1.47a	-1.66a
		Mirabegron 100 mg (433)	-1.63a	-1.75a
CAPRICORN	1302	Placebo (433)	-	-	[52]
		Mirabegron 25 mg (433)	-0.40a	-0.47a
		Mirabegron 50 mg (440)	-0.42a	-0.42a
Pooled analysis	3542	Placebo (1328)	-1.10	-1.20	[53]
		Mirabegron 50 mg (1324)	-1.49a	-1.75a
		Mirabegron 100 mg (890)	-1.50a	-1.74a

^aP < 0.05 vs placebo.

¹Mean adjusted changes from baseline to final visit. FAS: Full analysis set; FAS-I: Full analysis set-incontinence (all FAS patients with ≥ incontinence grade at baseline); NS: Not significant; ER: Extended release.