• Ann. Intern. Med. · Sep 2005

    Randomized Controlled Trial Clinical Trial

    Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial.

    • Dennis E Niewoehner, Kathryn Rice, Claudia Cote, Daniel Paulson, J Allen D Cooper, Larry Korducki, Cara Cassino, and Steven Kesten.
    • Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota 55417, USA. niewo001@umn.edu
    • Ann. Intern. Med. 2005 Sep 6; 143 (5): 317326317-26.

    BackgroundPatients with chronic obstructive pulmonary disease (COPD) frequently develop exacerbations, leading to major clinical and health resource use ramifications.ObjectiveTo prospectively evaluate the effectiveness of a long-acting inhaled anticholinergic bronchodilator, tiotropium, in reducing COPD exacerbations and exacerbation-related health care utilization.DesignRandomized, double-blind study.Setting26 Veterans Affairs medical centers.Patients1829 patients with moderate to severe COPD (mean baseline FEV(1), 36% predicted).InterventionOnce-daily tiotropium (18 microg) or placebo for 6 months. Patients otherwise received usual care, except for other anticholinergic bronchodilators.MeasurementsThe coprimary end points were the percentage of patients with a COPD exacerbation and the percentage of patients with a COPD-related hospitalization.ResultsTiotropium significantly reduced the percentage of patients experiencing 1 or more exacerbations compared with placebo (27.9% vs. 32.3%, respectively; difference, -5.7 percentage points [95% CI, -10.4 to -1.0 percentage points]; P = 0.037). Fewer tiotropium patients were hospitalized because of COPD exacerbation (7.0% vs. 9.5%, respectively; difference, -3.0 percentage points [CI, -5.9 to -0.1 percentage points]; P = 0.056), although this difference was of borderline statistical significance. Analysis of secondary outcomes indicates that tiotropium may lengthen the time to first COPD exacerbation (P = 0.028) and reduce health care utilization for exacerbations, including the frequency of hospitalizations (P = 0.047), unscheduled clinic visits (P = 0.019), and days of antibiotic treatment (P = 0.015). Tiotropium did not statistically significantly reduce all-cause hospitalization rates.LimitationsTrial participants were enrolled from 1 health care system, and 99% were men. The follow-up period extended for only 6 months.ConclusionsTiotropium reduces COPD exacerbations and may reduce related health care utilization in patients with moderate to severe COPD.

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