Chronic Obstructive Pulmonary Disease
Tiotropium bromide is used for the long-term symptomatic treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. In patients with moderate to severe COPD (e.g., forced expiratory volume in 1 second [FEV1] 30 to less than 80% of predicted or, alternatively, less than 60% of predicted) who have persistent symptoms not relieved by as-needed therapy with ipratropium and/or a selective, short-acting inhaled β2-agonist, maintenance monotherapy with a long-acting bronchodilator (e.g., orally inhaled salmeterol, formoterol, or tiotropium) or an inhaled corticosteroid may be used, and a short-acting, selective inhaled β2-agonist is used as needed for immediate symptom relief. Maintenance therapy with long-acting bronchodilators in patients with moderate to severe COPD is more effective and more convenient than regular therapy with short-acting bronchodilators. Data are insufficient to favor one maintenance monotherapy over another for use in such patients. Some clinicians recommend therapy with a combination of several long-acting bronchodilators such as tiotropium and a long-acting β-adrenergic agonist in selected patients with inadequate response. In patients with severe to very severe COPD (e.g., FEV1 less than 30 to less than 50% of predicted), some clinicians recommend addition of an inhaled corticosteroid to maintenance therapy with one or more long-acting bronchodilators given separately or in fixed combination; however, the benefits of combination therapy over monotherapy have not been consistently demonstrated. If symptoms are not adequately controlled with inhaled corticosteroids and a long-acting bronchodilator or if limiting adverse effects occur, addition or substitution of extended-release oral theophylline may be considered. Orally inhaled tiotropium is not indicated for the initial treatment of acute episodes of bronchospasm or acute exacerbations of COPD; a drug with a more rapid onset of action (e.g., a short-acting β-adrenergic agonist) may be preferred in such cases.
Currently available data indicate that tiotropium improves lung function (e.g., as determined by FEV1) in patients with COPD compared with ipratropium or placebo. Such improvement in lung function has been maintained throughout the 24-hour dosing interval and for treatment periods of up to 1 year with no evidence of tolerance. In some studies, treatment with tiotropium also has been associated with a reduction in the need for supplemental short-acting β2 agonists compared with placebo.
In several long-term (e.g., 1-year) comparative studies in patients with COPD, orally inhaled tiotropium (18 mcg once daily) improved lung function (e.g., as determined by mean change in trough FEV1, morning and evening peak expiratory flow rate [PEFR]) to a greater degree than ipratropium bromide (36 mcg 4 times daily) oral inhalation aerosol. In addition, treatment with tiotropium reduced dyspnea and the number of COPD exacerbations and increased the time to a first exacerbation compared with ipratropium bromide aerosol.
In two 6-month comparative trials in patients with COPD receiving either orally inhaled tiotropium (18 mcg once daily) or salmeterol (50 mcg twice daily), tiotropium was more effective in improving bronchodilation (e.g., FEV1, evening PEFR) than salmeterol therapy or placebo. In addition, while tiotropium or salmeterol each reduced dyspnea and improved FEV1 compared with placebo, tiotropium also was more effective than placebo in reducing COPD exacerbations and all-cause hospital admissions and improving quality-of-life scores in these trials.
For additional information on the treatment of COPD, see Uses: Chronic Obstructive Pulmonary Disease, in Ipratropium Bromide 12:08.08.