Table 2

Adjudicated primary causes of death (vital status analysis)

VariableTiotropium Respimat
2.5 μg (n=914)
Tiotropium Respimat
5 μg (n=918)
Tiotropium HandiHaler
18 μg (n=952)
Rate ratio (95% CI)
Tiotropium Respimat
2.5 μg vs HandiHaler 18 μg
Tiotropium Respimat
5 μg vs HandiHaler 18 μg
Adjudicated causes of death, n (rate/100 patient-years)77 (3.6)71 (3.3)92 (4.1)0.87 (0.64 to 1.17)0.79 (0.58 to 1.07)
 Cardiac disorders2 (0.1)2 (0.1)5 (0.2)0.41 (0.08 to 2.14)0.41 (0.08 to 2.10)
 General disorders12 (0.6)14 (0.6)18 (0.8)0.69 (0.33 to 1.43)0.79 (0.39 to 1.59)
 Neoplasms benign, malignant and unspecified25 (1.2)16 (0.7)18 (0.8)1.44 (0.79 to 2.64)0.91 (0.46 to 1.78)
 Respiratory, thoracic and mediastinal disorders29 (1.4)26 (1.2)33 (1.5)0.91 (0.55 to 1.50)0.80 (0.48 to 1.34)
  COPD28 (1.3)25 (1.1)28 (1.3)1.04 (0.61 to 1.75)0.91 (0.53 to 1.56)
 Infections and infestations6 (0.3)6 (0.3)4 (0.2)1.55 (0.44 to 5.51)1.53 (0.43 to 5.42)
 Nervous system disorders2 (0.1)1 (0.0)4 (0.2)0.52 (0.09 to 2.83)0.25 (0.03 to 2.28)
Patients with fatal MACE, n (rate/100 patient-years)11 (0.5)13 (0.6)20 (0.9)0.57 (0.27 to 1.19)0.66 (0.33 to 1.33)
 Sudden death5 (0.2)8 (0.4)5 (0.2)1.04 (0.30 to 3.58)1.63 (0.53 to 4.98)
 Sudden cardiac death2 (0.1)0 (0.0)5 (0.2)0.41 (0.08 to 2.14)
 Cerebrovascular accident1 (0.0)1 (0.0)4 (0.2)0.26 (0.03 to 2.32)0.25 (0.03 to 2.28)
 Cardiac failure congestion1 (0.0)1 (0.0)1 (0.0)1.04 (0.06 to 16.56)1.02 (0.06 to 16.29)
 Acute myocardial infarction1 (0.0)0 (0.0)0 (0.0)
 Aortic dissection0 (0.0)0 (0.0)1 (0.0)
 Aortic valve stenosis0 (0.0)0 (0.0)1 (0.0)
 Arteriosclerosis0 (0.0)1 (0.0)0 (0.0)
 Cardiac failure chronic0 (0.0)0 (0.0)1 (0.0)
 Cardiac valve disease0 (0.0)1 (0.0)0 (0.0)
 Cor pulmonale0 (0.0)0 (0.0)1 (0.0)
 Myocardial infarction0 (0.0)0 (0.0)1 (0.0)
 Peripheral vascular disorder0 (0.0)1 (0.0)0 (0.0)
 Subarachnoid haemorrhage1 (0.0)0 (0.0)0 (0.0)
  • Time at risk adjusted rate ratios of adjudicated causes of death by treatment, MedDRA (V.16.0) system organ class and preferred term.

  • COPD, chronic obstructive pulmonary disease; MACE, major adverse cardiovascular event (stroke, transient ischaemic attack, myocardial infarction, sudden death, cardiac death, sudden cardiac death or fatal event in the system organ classes for cardiac and vascular disorders); MedDRA, Medical Dictionary for Regulatory Activities.