Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Halpin DMG

PROVIDER: S-EPMC5556886 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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

Halpin David M G DMG Tashkin Donald P DP Celli Bartolome R BR Leimer Inge I Metzdorf Norbert N Decramer Marc M

Chronic obstructive pulmonary diseases (Miami, Fla.) 20150623 3

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 (FEV<sub>1</sub>) and St. George's Respiratory Questionnaire (S ...[more]

PMID: 28848846

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Project description:IntroductionTiotropium is prescribed for the treatment of chronic obstructive pulmonary disease (COPD) and delivered via HandiHaler(®) (18 μg once daily) or Respimat(®) Soft Mist™ inhaler (5 μg once daily). The recent TIOtropium Safety and Performance In Respimat(®) (TIOSPIR™) study demonstrated that both exhibit similar safety profiles. This analysis provides an updated comprehensive safety evaluation of tiotropium(®) using data from placebo-controlled HandiHaler(®) and Respimat(®) trials.MethodsPooled analysis of adverse event (AE) data from tiotropium HandiHaler(®) 18 μg and Respimat(®) 5 μg randomized, double-blind, parallel-group, placebo-controlled, clinical trials in patients with COPD (treatment duration ≥4 weeks). Incidence rates, rate ratios (RRs), and 95% confidence intervals (CIs) were determined for HandiHaler(®) and Respimat(®) trials, both together and separately.ResultsIn the 28 HandiHaler(®) and 7 Respimat(®) trials included in this analysis, 11,626 patients were treated with placebo and 12,929 with tiotropium, totaling 14,909 (12,469 with HandiHaler(®); 2,440 with Respimat(®)) patient-years of tiotropium exposure. Mean age was 65 years, and mean prebronchodilator forced expiratory volume in 1 second (FEV1) was 1.16 L (41% predicted). The risk (RR [95% CI]) of AEs (0.90 [0.87, 0.93]) and of serious AEs (SAEs) (0.94 [0.89, 0.99]) was significantly lower in the tiotropium than in the placebo group (HandiHaler(®) and Respimat(®) pooled results), and there was a numerically lower risk of fatal AEs (FAEs) (0.90 [0.79, 1.01]). The risk of cardiac AEs (0.93 [0.85, 1.02]) was numerically lower in the tiotropium group. Incidences of typical anticholinergic AEs, but not SAEs, were higher with tiotropium. Analyzed separately by inhaler, the risks of AE and SAE in the tiotropium groups remained lower than in placebo and similarly for FAEs.ConclusionThis analysis indicates that tiotropium is associated with lower rates of AEs, SAEs, and similar rates of FAEs than placebo when delivered via HandiHaler(®) or Respimat(®) (overall and separately) in patients with COPD.

Project description:BackgroundTiotropium Safety and Performance in Respimat® (TIOSPIR®) compared the safety and efficacy of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease (COPD). A prespecified spirometry substudy compared the lung function efficacy between treatment groups.MethodsTIOSPIR® was a large-scale, long-term (2.3-year), event-driven, randomized, double-blind, parallel-group trial of 17,135 patients with COPD. In the spirometry substudy, trough forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) were measured at baseline and every 24 weeks for the duration of the trial.ResultsThe substudy included 1370 patients who received once-daily tiotropium Respimat® 5 μg (n = 461), 2.5 μg (n = 464), or tiotropium HandiHaler® 18 μg (n = 445). Adjusted mean trough FEV1 (average 24-120 weeks) was 1.285, 1.258, and 1.295 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg groups (difference versus HandiHaler® [95 % CI]: -10 [-38, 18] mL for Respimat® 5 μg and, -37 [-65, -9] mL for Respimat® 2.5 μg); achieving noninferiority to tiotropium HandiHaler® 18 μg for tiotropium Respimat® 5 but not for 2.5 μg (prespecified analysis). Adjusted mean trough FVC was 2.590, 2.544, and 2.593 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg groups. The rates of FEV1 decline over 24 to 120 weeks were similar for the three treatment arms (26, 40, and 34 mL/year for the tiotropium Respimat® 5-μg, 2.5-μg, and HandiHaler® 18-μg groups). The rate of FEV1 decline in GOLD I + II patients was greater than in GOLD III + IV patients (46 vs. 23 mL/year); as well as in current versus ex-smokers, in patients receiving combination therapies at baseline versus not, and in those experiencing an exacerbation during the study versus not.ConclusionsThe TIOSPIR® spirometry substudy showed that tiotropium Respimat® 5 μg was noninferior to tiotropium HandiHaler® 18 μg for trough FEV1, but Respimat® 2.5 μg was not. Tiotropium Respimat® 5 μg provides similar bronchodilator efficacy to tiotropium HandiHaler® 18 μg with comparable rates of FEV1 decline. The rate of FEV1 decline varied based on disease severity, with a steeper rate of decline observed in patients with moderate airway obstruction.Trial registrationNCT01126437.

Dataset Information

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

Publications

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

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