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.

Table 2 Most frequent (> 2% in any treatment group) treatment emergent adverse events and adverse events of interest¹n (%)

MedDRA (v.9.1), preferred term	Mirabegron 50 mg (n = 812)	Mirabegron 100 mg (n = 820)	Tolterodine ER 4 mg (n = 812)
Any AE	485 (59.7)	503 (61.3)	508 (62.6)
Hypertension	75 (9.2)	80 (9.8)	78 (9.6)
Urinary tract infection	48 (5.9)	45 (5.5)	52 (6.4)
Dry mouth	23 (2.8)	19 (2.3)	70 (8.6)
Nasopharyngitis	32 (3.9)	35 (4.3)	25 (3.1)
Headache	33 (4.1)	26 (3.2)	20 (2.5)
Influenza	21 (2.6)	25 (3.0)	28 (3.4)
Constipation	23 (2.8)	25 (3.0)	22 (2.7)
Back pain	23 (2.8)	29 (3.5)	13 (1.6)
Dizziness	22 (2.7)	13 (1.6)	21 (2.6)
Diarrhea	15 (1.8)	24 (2.9)	16 (2.0)
Sinusitis	22 (2.7)	18 (2.2)	12 (1.5)
Arthralgia	17 (2.1)	19 (2.3)	16 (2.0)
Tachycardia	8 (1.0)	19 (2.3)	25 (3.1)
Cystitis	17 (2.1)	11 (1.3)	19 (2.3)
Adverse events of interest
Corrected QT interval prolongation2	3 (0.4)	2 (0.2)	3 (0.4)
Hypertension2	89 (11.0)	83 (10.1)	86 (10.6)
Cardiac arrhythmia2	32 (3.9)	34 (4.1)	49 (6.0)
Urinary retention	1 (0.1)	1 (0.1)	3 (0.4)
Acute urinary retenction	0	1 (0.1)	1 (0.1)
Hypersensitivity	45 (5.5)	44 (5.4)	42 (5.2)
Sincope/seizure	1 (0.1)	0	1 (0.1)
Hepatotoxicity2	17 (2.1)	19 (2.3)	15 (1.8)

¹In the safety analysis set;

²Definition based on standardized medical dictionary for regulatory activities (MedDRA) query. Adverse event not based on standardized MedDRA queries were predefined. Reprinted from reference[54], with permission. AE: Adverse Event; ER: Extended release.