Table 3.
Cardiovascular serious adverse events available by study results posted in the ClinicalTrials.gov repository database.
| Tiotropium HandiHaler 18 μg (n = 8,911) |
Tiotropium Respimat SMI 5 μg (n = 8,871) |
Tiotropium Respimat SMI 2.5 μg (n = 5,861) |
|
|---|---|---|---|
| n (%) | n (%) | n (%) | |
| Cardiac failure (including acute, chronic, congestive, tamponade) | 171 (1.88) | 83 (0.94) | 72 (1.23) |
| Myocardial infarction (including acute) | 118 (1.30) | 77 (0.87) | 74 (1.26) |
| Fibrillation (including atrial, flutter, ventricular) | 110 (1.21) | 49 (0.55) | 54 (0.92) |
| Angina (including pectoris, unstable) | 82 (0.90) | 55 (0.62) | 30 (0.51) |
| Tachycardia (including, atrial, sinus, supraventricular, ventricular) | 54 (0.59) | 37 (0.42) | 29 (0.49) |
| Aneurysm (including aortic, peripheral, rupture) | 40 (0.44) | 28 (0.32) | 22 (0.38) |
| Hypertension (including accelerated, crisis) | 38 (0.42) | 12 (0.14) | 13 (0.22) |
| Cardiac arrest | 38 (0.42) | 18 (0.20) | 12 (0.20) |
| Conduction disorders (including atrioventricular block, block complete, first degree block, bundle branch block left and right) | 35 (0.38) | 13 (0.5) | 8 (0.14) |
| Acute coronary syndrome | 34 (0.37) | 23 (0.26) | 12 (0.20) |
| Aortic disorders (including dissection, occlusion, rupture, stenosis, thrombosis) | 29 (0.32) | 8 (0.09) | 8 (0.14) |
| Arteriosclerosis (including coronary, obliterans) | 27 (0.30) | 12 (0.14) | 13 (0.22) |
| Cardiac disorders (including cardiomegaly, cardiomiopathy) | 25 (0.27) | 9 (0.10) | 1 (0.02) |
| Bradycardia (including sinus) | 23 (0.25) | 15 (0.17) | 9 (0.15) |
| Cardiovascular insufficiency | 17 (0.19) | 9 (0.10) | 12 (0.20) |
| Adams-Stokes syndrome | 16 (0.18) | 3 (0.03) | 5 (0.09) |
| Arteritis | 16 (0.18) | 7 (0.08) | 5 (009) |
| Varicose vein (including bleeding) | 15 (0.16) | 4 (0.05) | 4 (0.07) |
| Cardiac asthma | 12 (0.13) | 2 (0.02) | 5 (0.09) |
| Circulatory collapse | 12 (0.13) | 6 (0.07) | 3 (0.05) |
| Cor pulmonale (including acute, chronic) | 10 (0.11) | 5 (0.06) | 6 (0.10) |
| Coronary artery diseases (including embolism, insufficiency, occlusion, stenosis) | 10 (0.11) | 8 (0.09) | 7 (0.12) |
| Vein thrombosis | 9 (0.10) | 4 (0.05) | 4 (0.07) |
| Diastolic dysfunction | 8 (0.09) | 7 (0.08) | 5 (0.09) |
| Embolism | 6 (0.07) | 1 (0.01) | 0 (0.00) |
| Extrasystoles (including supraventricular, ventricular) | 4 (0.04) | 4 (0.05) | 5 (0.09) |
| Extremity necrosis | 4 (0.04) | 2 (0.02) | 1 (0.02) |
| Arterial disorders (including haemorrhage, insufficiency, occlusive disease, stenosis, thrombosis) | 4 (0.04) | 0 (0.00) | 0 (0.00) |
| Haematoma | 4 (0.04) | 5 (0.06) | 3 (0.05) |
| Haemorrhage | 4 (0.04) | 2 (0.02) | 5 (0.09) |
| Hypertensive cardiomyopathy | 4 (0.04) | 3 (0.03) | 4 (0.07) |
| Hypotension (including orthostatic) | 3 (0.03) | 0 (0.00) | 2 (0.03) |
| Shock (including cardiogenic, hypovolaemic, haemorragic) | 2 (0.02) | 0 (0.00) | 0 (0.00) |
| Artery stenosis (including iliac, peripheral, subclavian) | 2 (0.02) | 2 (0.02) | 4 (0.07) |
| Intermittent claudication | 2 (0.02) | 0 (0.00) | 0 (0.00) |
| Ischaemia (including ischaemic cardiomyopathy, myocardial and peripheral ischaemia) | 2 (0.02) | 2 (0.02) | 1 (0.02) |
| Ventricular disorders (including dysfunction, failure) | 2 (0.02) | 0 (0.00) | 0 (0.00) |
| Leriche syndrome | 1 (0.01) | 0 (0.00) | 0 (0.00) |
| Lymphoedema | 1 (0.01) | 1 (0.01) | 0 (0.00) |
| Valve diseases (including mixed, incompetence, stenosis) | 1 (0.01) | 0 (0.00) | 3 (0.05) |
| Palpitations | 1 (0.01) | 0 (0.00) | 1 (0.02) |
| Pericardial disorders (including effusion, pericarditis) | 1 (0.01) | 1 (0.01) | 1 (0.02) |
| Peripheral vascular disorder | 1 (0.01) | 0 (0.00) | 1 (0.02) |
| Post thrombotic syndrome | 1 (0.01) | 1 (0.01) | 0 (0.00) |
| Arrhythmia (including supraventricular, sinus arrhythmia, sick sinus syndrome, supraventricular, tachyarrhythmia, ventricular) | 1 (0.01) | 0 (0.00) | 0 (0.00) |
| Steal syndrome | 1 (0.01) | 0 (0.00) | 0 (0.00) |
| Vascular shunt | 1 (0.01) | 1 (0.01) | 0 (0.00) |
| Vasculitis | 0 (0.00) | 0 (0.00) | 1 (0.02) |
| Vasodilatation | 0 (0.00) | 1 (0.01) | 1 (0.02) |
| Venous insufficiency | 0 (0.00) | 0 (0.00) | 1 (0.02) |