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A 4-year trial of tiotropium in chronic obstructive pulmonary disease.

The New England journal of medicine

Aged, Bronchodilator Agents, adverse effects, pharmacology, therapeutic use, Cholinergic Antagonists, Disease Progression, Double-Blind Method, Drug Therapy, Combination, Female, Forced Expiratory Volume, drug effects, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Proportional Hazards Models, Pulmonary Disease, Chronic Obstructive, drug therapy, mortality, physiopathology, Quality of Life, Scopolamine Derivatives, Vital Capacity, Adult

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      Abstract

      Previous studies showing that tiotropium improves multiple end points in patients with chronic obstructive pulmonary disease (COPD) led us to examine the long-term effects of tiotropium therapy. In this randomized, double-blind trial, we compared 4 years of therapy with either tiotropium or placebo in patients with COPD who were permitted to use all respiratory medications except inhaled anticholinergic drugs. The patients were at least 40 years of age, with a forced expiratory volume in 1 second (FEV(1)) of 70% or less after bronchodilation and a ratio of FEV(1) to forced vital capacity (FVC) of 70% or less. Coprimary end points were the rate of decline in the mean FEV(1) before and after bronchodilation beginning on day 30. Secondary end points included measures of FVC, changes in response on St. George's Respiratory Questionnaire (SGRQ), exacerbations of COPD, and mortality. Of a total of 5993 patients (mean age, 65+/-8 years) with a mean FEV(1) of 1.32+/-0.44 liters after bronchodilation (48% of predicted value), we randomly assigned 2987 to the tiotropium group and 3006 to the placebo group. Mean absolute improvements in FEV(1) in the tiotropium group were maintained throughout the trial (ranging from 87 to 103 ml before bronchodilation and from 47 to 65 ml after bronchodilation), as compared with the placebo group (P<0.001). After day 30, the differences between the two groups in the rate of decline in the mean FEV(1) before and after bronchodilation were not significant. The mean absolute total score on the SGRQ was improved (lower) in the tiotropium group, as compared with the placebo group, at each time point throughout the 4-year period (ranging from 2.3 to 3.3 units, P<0.001). At 4 years and 30 days, tiotropium was associated with a reduction in the risks of exacerbations, related hospitalizations, and respiratory failure. In patients with COPD, therapy with tiotropium was associated with improvements in lung function, quality of life, and exacerbations during a 4-year period but did not significantly reduce the rate of decline in FEV(1). (ClinicalTrials.gov number, NCT00144339.) 2008 Massachusetts Medical Society

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      Most cited references 22

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          A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire.

          A need was identified for a fixed-format self-complete questionnaire for measuring health in chronic airflow limitation. A 76-item questionnaire was developed, the St. George's Respiratory Questionnaire (SGRQ). Three component scores were calculated: symptoms, activity, and impacts (on daily life), and a total score. Three studies were performed. (1) Repeatability was tested over 2 wk in 40 stable asthmatic patients and 20 patients with stable COPD. The coefficient of variation for the SGRQ total score was 19%. (2) SGRQ scores were compared with spirometry, 6-min walking distance (6-MWD), MRC respiratory symptoms questionnaire, anxiety, depression, and general health measured using the Sickness Impact Profile score. A total of 141 patients were studied, mean age 63 yr (range 31 to 75) and prebronchodilator FEV1, 47% (range 11 to 114%). SGRQ scores correlated with appropriate comparison measures. For example, symptom score versus frequency of wheeze, r2 = 0.32, p less than 0.0001; activity versus 6-MWD, r2 = 0.50, p less than 0.0001; impact versus anxiety, r2 = 0.38, p less than 0.0001. Multivariate analysis demonstrated that SGRQ scores summed a number of areas of disease activity. (3) Changes in SGRQ scores and other measures were studied over 1 yr in 133 patients. Significant correlations were found between changes in SGRQ scores and the comparison measures (minimum r2 greater than 0.05, p less than 0.01). Multivariate analysis showed that change in total SGRQ score summed changes in a number of aspects of disease activity. We conclude that the SGRQ is a valid measure of impaired health in diseases of chronic airflow limitation that is repeatable and sensitive.
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            Author and article information

            Journal
            18836213
            10.1056/NEJMoa0805800

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