Efficacy of Tiotropium in COPD Patients with FEV1 ≥ 60% Participating in the UPLIFT® Trial

Abstract

GOLD 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).

Keywords :

• Chronic obstructive pulmonary disease
• Bbronchodilator agents
• Qquality of life
• Ppulmonary function tests
• Eexacerbations.

Acknowledgments

The study was sponsored by Boehringer Ingelheim and Pfizer. The authors would like to thank Natalie Dennis from PAREXEL for editorial assistance, which was funded jointly by Boehringer Ingelheim and Pfizer.