[Early treatment of COPD with tiotropium]

Background: In a prespecified subgroup analysis of the 4-year trial "Understanding Potential Long-term Impacts on Function with Tiotropium", the efficacy of tiotropium versus control in patients with moderate COPD (GOLD II) was examined and compared with the pooled results of patients with more severe disease (GOLD III/IV).

Methods: Randomised, multicentre, double-blind, placebo-controlled, parallel-group study in 5993 patients over a period of 4 years. Patients received either tiotropium 18 µg or placebo once-daily. The study endpoints were the annual FEV1 decline as well as lung function parameters, health status, exacerbations and all-cause mortality.

Results: 46 % of the patients had moderate disease (GOLD II; tiotropium: n = 1384, control group: n = 1355) with a mean postbronchodilator FEV1 of 1.63 (0.37) L (59 % predicted). In these patients with moderate COPD, tiotropium significantly improved the absolute FEV1 values (pre-bronchodilator FEV1: 101 - 119 ml, post-bronchodilator FEV1: 52 - 82 ml, p < 0.001) and the postbronchodilator FEV1 decline compared with the control patients (43 (2) vs. 49 (2) ml/year; p = 0.024). In addition, there was a statistically significant improvement in the annual exacerbation rate (tiotropium: 0.56, control: 0.7; p < 0.0001), the time to first exacerbation (tiotropium: 23.09, control: 17.47 months; p < 0.0001) and health status (tiotropium vs. control: minus 2.7 - 4 units; p < 0.0001) in the tiotropium group.

Conclusions: The results of this subgroup analysis support current guideline recommendations and indicate that already patients with moderate COPD (GOLD stage II) benefit clinically from treatment with tiotropium.