Efficacy of Tiotropium in COPD Patients with FEV1 ≥ 60% Participating in the UPLIFT® Trial
2012; Informa; Volume: 9; Issue: 3 Linguagem: Inglês
10.3109/15412555.2012.656211
ISSN1541-2555
AutoresDonald P. Tashkin, Bartolomé R. Celli, Marc Decramer, Theodore C. Lystig, Dacheng Liu, Steven Kesten,
Tópico(s)Pneumonia and Respiratory Infections
ResumoGOLD stage II COPD encompasses patients with FEV1 50–80% predicted. A published trials review suggested that benefits of maintenance therapy are limited to patients with FEV1 <60% predicted. We previously reported data demonstrating the efficacy of tiotropium in GOLD stage II disease in the 4-year UPLIFT® trial, and present here a further analysis of a sub-category of GOLD stage II patients with post-bronchodilator FEV1 ≥60% predicted from UPLIFT®. Outcomes included pre- and post-bronchodilator spirometry, exacerbations, SGRQ and mortality. Of the 5,992 UPLIFT® cohort, 1,210 (632 tiotropium, 578 control) had baseline post-bronchodilator FEV1 ≥60% predicted (range 60–78%), mean age was 64 years, 70% were men, and mean SGRQ total score was 39.9 units. Mean annual rate of post-bronchodilator FEV1 decline was 41 (tiotropium) and 49 (control) mL/year (P = 0.07); corresponding pre-bronchodilator values were 32 and 37 mL/year (P = 0.24). Morning pre-drug FEV1 and FVC improvements for tiotropium versus control were 87–127 mL and 139–186 ml, respectively (P < 0.001, all time-points). SGRQ total score improvements (tiotropium–control) were 2.0–3.4 units (P < 0.05 for all); a higher percentage of patients had an improvement of ≥4 units with tiotropium (P <0.05). Tiotropium reduced risk for an exacerbation (HR [95% CI] = 0.83 [0.71, 0.96]) and mortality for the 4-year protocol-defined treatment period (HR [95% CI] = 0.66 [0.45, 0.96]). Tiotropium treatment provides clinical efficacy in patients with GOLD stage II disease with an FEV1 ≥60% predicted, supporting current GOLD guidelines for COPD treatment. (ClinicalTrials.gov number NCT00144339).
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