Aim: To assess the effect of tiotropium 18 mcg once daily on chronic obstructive pulmonary disease (COPD) exacerbations and exacerbation-related hospitalisations using a patient-level pooled analysis.
Methods: All completed randomised, placebo-controlled, parallel-group tiotropium trials with a duration of >or=24 weeks were included (n=9). An exacerbation was defined in each study as >or=2 respiratory symptoms lasting >or=3 days, and requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.
Results: Compared with placebo (2,862 patients), tiotropium (3,309 patients) significantly reduced by 21% both the risk of COPD exacerbation (95% confidence interval [CI] 0.73-0.86; p<0.0001) and the risk of exacerbation-associated hospitalisation (95% CI 0.65-0.96; p=0.015). Time to first exacerbation and first associated hospitalisation were increased. The protective effect of tiotropium was consistent regardless of age, gender, inhaled corticosteroid use and disease severity.
Conclusion: This analysis provides further confirmatory evidence that tiotropium reduces the risk of exacerbation and associated hospitalisation.