Adverse events | Tiotropium, n=4767 | LABA,* n=6073 | Crude | Adjusted | |||||
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.