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]
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) |