Table 3

Incidence rates and adjusted rate ratio estimates in new users of long-acting bronchodilators

Adverse events	Tiotropium, n=4767			LABA,^* n=6073			Crude	Adjusted
Adverse events	n	Pyrs	Rate^†	n	Pyrs	Rate	RR	HR	95% CI
Death (any)	152	2775	5.48	170	2303	7.38	0.74	0.70	0.56 to 0.89
Cardiovascular
Aneurysm	17	2765	0.61	13	2298	0.57	1.09	0.96	0.44 to 2.05
Atrial fibrillation/flutter	87	2725	3.19	76	2272	3.34	0.95	0.99	0.71 to 1.38
Cardiac arrest	3	2774	0.11	4	2303	0.17	0.65	─	─
Coronary artery disease	125	2712	4.61	102	2255	4.52	1.02	1.11	0.84 to 1.47
Angina	53	2746	1.93	38	2275	1.67	1.16	1.38	0.88 to 2.16
Myocardial infarction	35	2765	1.27	23	2297	1.00	1.26	1.26	0.72 to 2.21
Heart failure	93	2738	3.40	105	2265	4.64	0.73	0.85	0.63 to 1.14
Hypertension	169	2654	6.37	163	2232	7.30	0.87	1.03	0.81 to 1.29
Stroke	45	2750	1.64	28	2296	1.22	1.34	1.49	0.91 to 2.45
Syncope	35	2762	1.27	35	2289	1.53	0.83	0.94	0.57 to 1.55
Tachycardia	15	2769	0.54	11	2296	0.48	1.13	1.08	0.48 to 2.41
Ventricular tachycardia	2	2774	0.07	1	2302	0.04	1.66	─	─
Respiratory
Asthma exacerbation	98	2716	3.61	395	2140	18.46	0.20	0.46	0.36 to 0.57
COPD exacerbation	287	2637	10.88	313	2168	14.44	0.75	0.95	0.80 to 1.12
Pneumonia	35	2757	1.27	34	2297	1.48	0.86	0.96	0.58 to 1.58
Other
Constipation	137	2708	5.06	124	2251	5.51	0.92	0.95	0.74 to 1.23
Dry mouth	26	2762	0.94	7	2299	0.30	3.09	3.66	1.52 to 8.78
Dysphagia	39	2757	1.41	32	2292	1.40	1.01	1.02	0.62 to 1.69
Paralytic ileus/bowel obstruction	4	2775	0.14	7	2301	0.30	0.47	─	─
Renal failure	34	2760	1.23	19	2295	0.83	1.49	1.40	0.77 to 2.55
Urinary retention	29	2765	1.05	25	2290	1.09	0.96	0.97	0.55 to 1.70
Tremor	16	2769	0.58	23	2292	1.00	0.58	0.62	0.31 to 1.22

↵* Single-ingredient formulations.
↵† Rate per 100 person-years.
‘─’ signifies the adjusted results are not presented as there are <5 events in either tiotropium or LABA users.
COPD, chronic obstructive pulmonary disease; LABA, long-acting β-agonists; N, number of patients; Pyrs, person-years at risk; RR, rate ratio; HR, relative hazard estimated using Cox' proportional hazards model adjusted for propensity score.