Table 1.
Summary of all clinical trial data for tiotropium and salmeterol
| Casaburi18 | Vincken15 | Donohue22 | Rennard19 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Tiotropium | Placebo | Tiotropium | Ipratropium | Tiotropium | Salmeterol | Placebo | Salmeterol | Ipratropium | Placebo | |
| Number of patients (n) | 550 | 371 | 356 | 179 | 209 | 213 | 201 | 97 | 97 | 109 |
| Age (years) | 65 ± 9 | 65 ± 9 | 63.6 ± 8.2 | 64.5 ± 8.1 | 64.5 ± 7.9 | 64.6 ± 8.1 | 65.6 ± 7.8 | 63.9±0.9 | 61.7 ± 0.8 | 63.7 ± 0.7 |
| Disease duration (years) | 8.6 ± 7.4 | 8.9 ± 6.8 | 11.4 ± 9.9 | 11.2 ± 9.6 | 9.2 ± 7.8 | 10.4 ± 8.2 | 9.7 ± 7.9 | |||
| Smoking history (pack years) | 63 | 59 | 34.3 ± 18.6 | 33.2 ± 16.7 | 47 ± 25 | 48 ± 26 | 46 ± 24 | |||
| Male | 66.5% | 62.8% | 84% | 86% | 74% | 75% | 75% | 61% | 64% | 64% |
| Completed study | 81.30% | 72.20% | 84.80% | 78.80% | 88% | 83% | 72% | 88% | 83% | 72% |
| No efficacy | 2.40% | 7% | 0.80% | 1.70% | 2% | 3% | 3% | |||
| Adverse events | 9.60% | 13.70% | 10.10% | 12.80% | 5.70% | 13.60% | 19.40% | 1% | 7% | 8% |
| At least 1 exacerbation/year | 36% | 42% | 35% | 46% | 36.80% | 38.50% | 45.80% | 20.70% | 30.80% | 32.90% |
| Exacerbation/patient/year | 0.086 | 0.161 | 0.073 | 0.96 | – | – | – | – | – | – |
| Hospitalized days/patient/year | 0.6 days | 1.2 days | 0.1 | 0.08 | – | – | – | – | – | – |
| Death | 7 (1.3%) | 7 (1.9%) | 2.50% | 1.70% | 0 | 3 | 4 | 0 | 3 | 4 |