Effect of Tiotropium on Outcomes in Patients With COPD, Categorized Using the New GOLD Grading System: Results of the UPLIFT® Randomized Controlled Trial.

A retrospective analysis of the Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT®) trial data was performed, grading patients by the 2013 Global initiative for chronic Obstructive Lung Disease (GOLD) severity groups. The number of antibiotics/systemic corticosteroids courses and hospitalizations/emergency department (ED) visits for COPD in the preceding year, baseline forced expiratory volume in 1 second (FEV1) and St. George's Respiratory Questionnaire (SGRQ) score were used to grade patients: 357 (6.3%), 1421 (24.9%), 299 (5.2%), and 3636 (63.7%) in Groups A-D, respectively. Mean FEV1 was higher and SGRQ scores lower with tiotropium than usual care (control) in all GOLD groups at all post-baseline time points during treatment. In the control group, mean (95% confidence interval [CI]) exacerbation rates per patient per year were highest in Group D (1.01 [0.96, 1.07]), similar in Groups B (0.63 [0.57, 0.69]) and C (0.72 [0.59, 0.87]), and lowest in Group A (0.48 [0.39, 0.59]). Tiotropium significantly prolonged time to first exacerbation versus control in Groups B and D (hazard ratios [95% CI]: 0.79 [0.69, 0.91] and 0.89 [0.82, 0.96]); in Groups A and C, similar effects were observed, reflecting the small size of these groups. The number of exacerbations per patient-year was lower with tiotropium than control in all GOLD groups (rate ratios 0.64, 0.72, 0.91, and 0.89 for Groups A-D; p < 0.005 for all but Group C (p = 0.4978). The incidence rate of major adverse cardiac events was higher in Group D than in Groups A-C but lower within the group in patients treated with tiotropium. In conclusion, tiotropium improved lung function and health status, and reduced exacerbation rates in patients in all GOLD groups.

RCT Entities:   Population Interventions Outcomes