Table 3.

Risk and rate of exacerbations (on treatment analysis*)

Variable	Tiotropium Respimat 2.5 μg (n=914)	Tiotropium Respimat 5 μg (n=917)	Tiotropium HandiHaler 18 μg (n=951)	HR (95% CI); p value
				Tiotropium Respimat 2.5 μg vs HandiHaler 18 μg	Tiotropium Respimat 5 μg vs HandiHaler 18 μg
Any exacerbation
Patients with event, n (%)	573 (62.7)	560 (61.1)	578 (60.8)	1.03 (0.92 to 1.16); p=0.614	0.96 (0.86 to 1.08); p=0.517
Number of events	1484	1508	1548
Adjusted rate of events/patient-year (95% CI)	0.83 (0.77 to 0.91)	0.83 (0.76 to 0.90)	0.81 (0.74 to 0.87)
Moderate-to-severe exacerbation
Patients with event, n (%)	561 (61.4)	550 (60.0)	571 (60.0)	1.01 (0.90 to 1.14); p=0.817	0.96 (0.85 to 1.07); p=0.441
Number of events	1462	1474	1525
Adjusted rate of events/patient-year (95% CI)	0.82 (0.75 to 0.89)	0.81 (0.74 to 0.88)	0.79 (0.73 to 0.86)
Severe (hospitalised) exacerbation
Patients with event, n (%)	172 (18.8)	173 (18.9)	172 (18.1)	1.04 (0.85 to 1.29); p=0.690	1.03 (0.84 to 1.28); p=0.760
Number of events	264	283	267
Adjusted rate of events/patient-year (95% CI)	0.15 (0.13 to 0.18)	0.16 (0.13 to 0.19)	0.14 (0.12 to 0.17)

Two patients from centres with data irregularities were excluded.

*Includes first day after treatment stop.