@article {HalpinP2190, author = {David Halpin and Marc Decramer and Bart Celli and Antonio Mart{\'\i}n and Inge Leimer and Norbert Metzdorf and Donald Tashkin}, title = {Effectiveness of tiotropium in low-risk patients according to new GOLD severity grading}, volume = {40}, number = {Suppl 56}, elocation-id = {P2190}, year = {2012}, publisher = {European Respiratory Society}, abstract = {Background: GOLD recently updated their COPD severity classification to include risk of exacerbations. Increased risk is typically defined by a FEV1 of \<50\% pred and/or >=2 exacerbations in the previous year (C+D) and low risk by a FEV1 >=50\% pred and 0-1 exacerbation in the previous year (A+B).Aims and objectives: To examine the effect of tiotropium 18 {\textmu}g qd via Handihaler{\textregistered} in GOLD low risk patients (pts) using data from a 4-y, randomized, double-blind, placebo-controlled trial in COPD (UPLIFT{\textregistered}).Methods: Retrospective analysis of exacerbations, lung function and QoL (SGRQ) in low-risk pts (pts with a baseline postbronchodilator [BD] FEV1 \%pred >=50\% and <=1 oral steroid/antibiotic course in the previous year). Pts with high risk (FEV1 \%pred \<50\% or more than 1 course of oral steroids/antibiotics) were also analyzed.Results: 2012 pts were analyzed (mean age 64.5{\textpm}8.6 y, male 74\%, mean ({\textpm}SD) baseline postBD FEV1 1.65 (0.37) L and FEV1 \%pred ({\textpm}SD) 58.9 (5.8). The HR (tiotropium vs control) for time to first exacerbation was 0.76 (95\% CI, 0.68; 0.86; P\<0.0001); mean annual exacerbation rates were 0.43 (95\% CI, 0.40; 0.48) vs 0.61 (0.56; 0.66), rate ratio 0.72 (0.63; 0.81; P\<0.0001). The SGRQ total score after 4 y was significantly improved by tiotropium vs placebo: -3.63 (95\% CI, -5.14; -2.12; P\<0.0001) and the respective increase for trough FEV1 was 110 mL (95\% CI, 84; 136; P\<0.0001). SGRQ and trough FEV1 were significantly improved at all time points. The above-mentioned endpoints were also significantly improved in the high-risk population.Conclusion: Tiotropium qd was effective throughout 4 y in reducing exacerbations and improving lung function and QoL in low-risk pts with COPD (GOLD A+B).}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/40/Suppl_56/P2190}, eprint = {https://erj.ersjournals.com/content/40/Suppl_56/P2190.full.pdf}, journal = {European Respiratory Journal} }