Skip to main content

Table 2 Summary of cardiac safety (Holter ECG) data for patients receiving tiotropium Respimat® or tiotropium HandiHaler® in four randomized trials. Placebo data are shown for comparison [32]

From: A systematic review of comparative studies of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease: does inhaler choice matter?

  Respimat® 5 μg HandiHaler® 18 μg Placebo
Average heart rate (BPM), mean ± SD (min–max)
Study 205.284
  Baseline 79.89 ± 10.88 (59–108) 81.35 ± 9.14 (52–97)
  Day 84 80.19 ± 9.78 (61–103) 81.12 ± 12.36 (54–140)
Studies 205.254/255
  Baseline 77.64 ± 10.05 (50–100) 79.26 ± 11.56 (55–136)
  Day 281 77.23 ± 9.68 (56–99) 77.62 ± 11.21 (53–111)
Study 205.458
  Day 26 75.36 ± 10.77 (51–108) 75.83 ± 10.35 (58–100) 75.91 ± 10.91 (56–106)
  Day 29 76.87 ± 10.82 (54–104) 77.39 ± 10.44 (55–104) 77.02 ± 10.36 (59–103)
Pauses, n/N (%)
Study 205.284
  Baseline 2/74 (2.7) 1/65 (1.5)
  Day 84 3/86 (3.5) 0
Studies 205.254/255
  Baseline 2/121 (1.7) 3/109 (2.8)
  Day 281 1/103 (1.0) 2/73 (2.7)
Study 205.458
  Day 26 0 1/113 (0.9) 0
  Day 29 0 0 0
VPB singles, n/N (%)
Study 205.284
  Baseline 61/74 (82.4) 54/65 (83.1)
  Day 84 71/86 (82.6) 58/78 (74.4)
Studies 205.254/255
  Baseline 112/121 (92.6) 95/109 (87.2)
  Day 281 86/103 (83.5) 66/73 (90.4)
Study 205.458
  Day 26 90/112 (80.4) 88/113 (77.9) 93/117 (79.5)
  Day 29 94/116 (81.0) 96/114 (84.2) 91/116 (78.4)
SVPB singles, n/N (%)
Study 205.284
  Baseline 66/74 (89.2) 60/65 (92.3)
  Day 84 82/86 (95.3) 74/78 (94.9)
Studies 205.254/255
 Baseline 113/121 (93.4) 101/109 (92.7)
 Day 281 96/103 (93.2) 68/73 (93.2)
Study 205.458
  Day 26 100/112 (89.3) 105/113 (92.9) 111/117 (94.9)
  Day 29 108/116 (93.1) 107/114 (93.9) 109/116 (94.0)
  1. BPM beats per minute, ECG electrocardiogram, FAS full analysis set, N number of patients with non-missing data; n, number of patients with event, SD standard deviation, SVPB supraventricular premature beat, VPB ventricular premature beat. A pause was defined as absence of a heart beat for >3 s