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.