Efficacy of tiotropium in the prevention of exacerbations of COPD.

Exacerbations are the most frequent cause of medical visits, hospital admissions and death among patients with chronic obstructive pulmonary disease (COPD). Tiotropium bromide is a long-acting bronchodilator that has demonstrated clinical efficacy in significantly improving the FEV(1) and health-related quality of life (HRQL) in patients with COPD. The prolonged and persistent bronchodilation achieved with tiotropium may reduce the exacerbation and COPD-related hospitalisation rates. The effect of tiotropium treatment on the incidence of exacerbations has been determined (as a secondary outcome) in registration trials. There are studies designed specifically to demonstrate the effect of tiotropium on the reduction in the frequency of exacerbations. Two of these studies of 6-month and 1-year duration demonstrated an additional significant benefit in the reduction of exacerbations and hospitalisations. The recent UPLIFT trial included 5993 patients followed for 4 years and, compared with control, tiotropium significantly delayed time-to-first exacerbation (16.7 versus 12.5 months) and time-to-first hospitalisation for exacerbations (lower risk of hospitalisation; HR, 0.86 [95% CI = 0.78-0.95]; p = 0.002). Tiotropium also reduced the mean number of exacerbations by 14% (rate per patient-year, 0.73 versus 0.85; HR, 0.86 [95% CI = 0.81-0.91]; p < 0.001). It is important to highlight that the control group in the UPLIFT trial consisted of patients with usual treatment for COPD, which included inhaled corticosteroids and/or long-acting beta-2 agonists in up to 62% of cases at baseline and up to 73% of cases at any time during follow-up. The new clinical trials have demonstrated a significant reduction in exacerbations and hospitalisations, even in patients treated with other drugs that can potentially prevent exacerbations.