Table 4.

Adverse CV and mortality outcomes during current use of mirabegron or antimuscarinics (matched episodes), according to prior OAB medication use

Outcomes	Episodesa	Cases	Person-years	Incidence rate (95% CI)b	Fixed effects	Random effects	I2 (%)
					HR (95% CI)c	HR (95% CI)c
Naïved
MACEe
Mirabegron	110,983	1336	57,581	23.20 (21.98–24.47)	0.90 (0.83–0.97)	0.89 (0.78–1.02)	44.54
Antimuscarinics	106,310	1143	45,302	25.23 (23.80–26.73)	Ref	Ref
AMI
Mirabegron	111,103	315	58,135	5.42 (4.85–6.04)	0.89 (0.76–1.05)	0.89 (0.70–1.13)	37.92
Antimuscarinics	106,444	273	45,678	5.98 (5.30–6.72)	Ref	Ref
Stroke
Mirabegron	111,031	782	57,780	13.53 (12.61–14.51)	0.96 (0.86–1.07)	0.98 (0.86–1.11)	15.60
Antimuscarinics	106,367	602	45,468	13.24 (12.21–14.33)	Ref	Ref
CV mortality
Mirabegron	111,158	338	58,293	5.80 (5.21–6.44)	0.79 (0.68–0.92)	0.75 (0.56–1.02)	62.40
Antimuscarinics	106,507	355	45,814	7.75 (6.97–8.59)	Ref	Ref
All-cause mortality
Mirabegron	111,158	2156	58,023	37.16 (35.61–38.75)	0.73 (0.69–0.78)	0.73 (0.68–0.80)	25.80
Antimuscarinics	106,507	2148	45,623	47.08 (45.12–49.10)	Ref	Ref
Non-naïved
MACEe
Mirabegron	40,498	371	20,037	18.52 (16.70–20.47)	1.07 (0.93–1.23)	1.07 (0.92–1.24)	2.92
Antimuscarinics	41,549	393	22,342	17.59 (15.92–19.39)	Ref	Ref
AMI
Mirabegron	40,605	86	20,249	4.25 (3.42–5.22)	1.09 (0.81–1.48)	1.09 (0.77–1.54)	16.93
Antimuscarinics	41,683	90	22,524	4.00 (3.23–4.89)	Ref	Ref
Stroke
Mirabegron	40,529	213	20,106	10.59 (9.24–12.09)	1.08 (0.89–1.31)	1.08 (0.86–1.36)	17.53
Antimuscarinics	41,598	216	22,409	9.64 (8.42–10.99)	Ref	Ref
CV mortality
Mirabegron	40,640	108	20,309	5.32 (4.38–6.39)	0.97 (0.75–1.26)	0.97 (0.75–1.26)	0.00
Antimuscarinics	41,737	130	22,588	5.76 (4.83–6.81)	Ref	Ref
All-cause mortality
Mirabegron	40,640	580	20,256	28.63 (26.37–31.04)	0.97 (0.87–1.09)	0.97 (0.87–1.09)	0.00
Antimuscarinics	41,737	654	22,549	29.00 (26.85–31.29)	Ref	Ref

AMI acute myocardial infarction, CI confidence interval, CMA Comprehensive Meta-Analysis, CV cardiovascular, HR hazard ratio, MACE major adverse cardiovascular events, OAB overactive bladder, Ref reference group

^aWhere multiple individual antimuscarinic treatment episodes were joined to form a single period of current exposure, only the first matched episode during the period of current exposure was counted

^bIncidence rates were calculated in terms of per 1000 person-years. CIs were calculated using Byar’s formula [23]

^cHRs and corresponding CIs were calculated using CMA Version 3 software

^dNon-naïve users had received a prescription for another OAB medication during the prior 12 months and naïve users had not received a prescription for another OAB medication during the prior 12 months

^eThe number of AMI, stroke and CV mortality cases do not sum to the number of MACE cases. For patients with more than one of the individual outcomes, the earliest individual outcome was counted towards the MACE total