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)

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