Patient-level pooled analysis of the effect of tiotropium on COPD exacerbations and related hospitalisations.

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.

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