Understanding the effects on HR-QoL of treatment for overactive bladder: a detailed analysis of EQ-5D clinical trial data for mirabegron

Figures & data

Figure 1. Randomization of patients to treatment arms from pooled clinical trial data and description of the resulting EQ-5D Full Analysis Set (FAS) and Mod-ITT Set (Mod-ITT).

Table 1. Patients’ baseline characteristics by treatment group (mod-ITT).

	Placebo (n = 1108)	Mirabegron 25 mg (n = 369)	Mirabegron 50 mg (n = 1105)	Mirabegron 100 mg (n = 759)	Tolterodine SR 4 mg (n = 400)
Age (years). Mean; SD	58.9 (13.2)	59.2 (12.4)	59.6 (12.4)	59.8 (12.5)	59.1 (12.6)
Women (%)	72.7	66.1	71.0	72.7	72.5
BMI (kg/m^2). Mean; SD**	29.1 (6.5)	29.5 (6.3)	29.0 (6.1)	29.2 (6.1)	27.8 (5.0) (ALL)
Time from OAB DX (median months)*	51.9	60.1 (M50 TOL)	52.7	53.3	46.6 (M25 M100)
Type of OAB*			(PLC M100)		(PLC M100)
Urge incontinence only (%)	32.4	38.8	38.1	32.3	41.0
Mixed/Urge predominant (%)	30.5	28.7	30.6	31.4	20.7
Urge w.o. incontinence (%)	37.1	32.5	31.3	36.3	38.3
Previous medication for OAB (%)	52.6	52.9	51.7	50.7	49.3
Previous surgery of OAB (%)*	8.0	6.5	9.7	8.2	4.3 (PLC M25 M100)
History of benign prostatic hyperplasia (%)	11.5	13.0	10.8	11.1	10.3
History of diabetes (%)	7.8	9.5	8.1	8.8	6.0
Ongoing treatment with diuretics (%)	15.9	16.5	15.0	15.7	14.8
History of hyperlipidemia (%)**	24.1	26.3	24.9	22.1	15.0 (ALL)
Activity impairment (%). Mean; SD**	36.7 (25.9)	35.2 (25.7)	37.1 (26.6)	37.8 (26.2)	43.1 (27.3) (ALL)
OAB-q Total Score. Mean; SD	62.2 (21.3)	65.1 (20.8)	63.0 (21.4)	61.9 (21.7)	61.3 (21.2)
Level of urgency; Mean; SD*	2.4 (0.5)	2.4 (0.5)	2.4 (0.5)	2.5 (0.5) (PLC M25)	2.4 (0.5)
No. urgency episodes/24 h; Mean; SD*	5.5 (3.5)	5.6 (3.6)	5.8 (3.7)	6.0 (3.6) (PLC M25)	5.8 (3.4)
Patient perception of bladder condition at baseline:**					(ALL)
No problems at all (%)	1.4	1.1	1.7	1.3	1.0
Some very minor problems (%)	5.7	9.2	7.2	6.7	3.8
Some minor problems (%)	19.3	19.8	16.4	19.2	12.3
Some moderate problems (%)	42.2	38.0	46.3	41.3	35.3
Severe problems (%)	26.9	25.0	23.3	26.3	40.3
Many severe problems (%)	4.5	6.8	5.1	5.2	7.3

Overall p-value: *p < 0.05; **p < 0.001.

ALL, p < 0.05 vs ALL other arms; PLC, p < 0.05 vs Placebo; TOL, p < 0.05 vs Tolterodine ER 4 mg; M25, p < 0.05 vs Mirabegron 25 mg; M50, p < 0.05 vs Mirabegron 50 mg; M100, p < 0.05 vs Mirabegron 100 mg.

Table 2. Patients’ baseline EQ-5D profiles by treatment group (mod-ITT).

	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
	(n = 1108)	(n = 369)	(n = 1105)	(n = 759)	(n = 400)
Mobility:
Level 1 (%)	80.2	81.8	79.0	75.6	77.8
Level 2 (%)	19.6	18.2	20.8	24.4	22.2
Level 3 (%)	0.2	0	0.2	0	0
Self-care:
Level 1 (%)	95.6	97.3	96.7	96.3	95.0
Level 2 (%)	4.3	2.7	3.1	3.6	5.0
Level 3 (%)	0.1	0	0.2	0.1	0
Usual Activities:
Level 1 (%)	75.8	82.1	75.5	74.6	70.0
Level 2 (%)	23.9	17.6	23.9	24.4	29.0
Level 3 (%)	0.3	4.3	0.6	1.0	1.0
Pain/Discomfort:
Level 1 (%)	56.4	60.2	53.3	56.7	52.0
Level 2 (%)	39.8	37.7	42.5	40.0	43.3
Level 3 (%)	3.8	2.1	4.2	3.3	4.7
Anxiety/Depression:
Level 1 (%)	61.2	65.9	61.7	60.6	52.0
Level 2 (%)	35.6	32.5	35.0	36.4	43.0
Level 3 (%)	3.2	1.6	3.3	3.0	5.0
EQ-VAS. Mean, SD*	71.9 (18.8)	74.5 (18.0) (ALL)	71.4 (18.8)	71.1 (19.1)	64.1 (20.1) (ALL)
Utility Score (UK value sets). Mean; SD*	0.81 (0.22)	0.84 (0.19) (ALL)	0.80 (0.22)	0.80 (0.21)	0.77 (0.23) (ALL)

Overall p-value: * p < 0.001; ALL, p < 0.05 vs ALL other arms.

Figure 2. EQ-5D questionnaire: Utility index (UK value sets), adjusted changes from baseline (LS means)–modified ITT.

Figure 3. Changes from baseline in UK Index scores: adjusted AUC’s (LS means) on 12 weeks–modified ITT (based on the sub-set of patients with EQ-5D profiles worse than 11111 at baseline).

Figure 4. EQ-VAS adjusted changes from baseline (LS means), modified ITT set.

Figure 5. Pareto classification of health change from baseline to health status at 12 weeks, modified ITT set.