Tab. VIII.

Adverse events (AEs) associated with antimuscarinic agents: incidence with mirabegron, placebo and tolterodine ER (4 mg). A) Data from SCORPIO, ARIES and CAPROCORN pooled analysis [69]. B) Summary of mirabegron clinical safety in two phase III studies [71, 79]. C) Selected AEs from 12 months mirabegron trial [58]

A)
Adverse event	Placebo	Mirabegron				Tolterodine ER (4 mg)	Systematic therapy and meta-analysis
		25 mg	50 mg	100 mg	Total
	n = 1380	n = 432	n = 1375	n = 929	n = 2736	n = 495	Antimuscarinic therapy	Placebo
	%
Any adverse event	47.7	48.6	47.1	43.3	46.0	46.7	53.4	39.9
Dry mouth	2.1	1.9	1.7	2.5	2.0	10.1	29.6	7.9
Pruritus	0.4	0/2	0.2	0.3	0.3	1.4	15.4	5.2
Constipation	1.4	1.6	1.6	1.6	1.6	2.0	7.7	3.9
Erythema	0.1	0	0.1	0.1	0.1	0.2	6.9	2.0
Vision blurred	0.2	0	0.1	0.4	0.2	0	3.8	2.6
Fatigue	1.0	1.4	1.2	0.8	1.1	1.8	1.6	0.6
Urinary retention	0.4	0	0.1	0	<0.1	0.6	1.1	0.2
B)
Phase III studies	Adverse events				Placebo	Mirabegron		Tolterodine ER (4 mg)
						50 mg	100 mg
					%
European-Australian study	Dry mouth				2.6	2.8	2.8	10.1
	Constipation				1.4	1.6	1.6	2.0
	Hypertension				7.7	5.9	5.4	8.1
	Headache				2.8	3.7	1.8	3.6
	Urinary tract infections				1.4	1.4	1.8	2.0
	Any adverse events				43.3	42.8	40.1	46.7
American study	Dry mouth				1.5	0.5	2.1
	Constipation				1.8	1.4	1.6
	Hypertension				6.6	6.1	4.9
	Headache				2	3.2	3.0
	Urinary tract infections				1.8	2.7	3.7
	Any adverse events				50.1	51.6	46.9
C)
Adverse event					Mirabegron		Tolterodine ER (4 mg)
					50 mg	100 mg
					%
Any adverse event					59.7	61.3	62.6
Hypertension					11.0	10.1	10.6
Cardiac arrhythmia					3.9	4.1	6.0
Corrected QT interval prolongation					0.4	0.2	0.4
Constipation					2.8	3.0	2.7
Dry mouth					2.8	2.3	8.6
Urinary tract infections					5.9	5.5	6.4
Dizziness					2.7	1.6	2.6