Salmeterol plus theophylline combination therapy in the treatment of COPD

Background: Patients with COPD often require multiple therapies to improve lung function and decrease symptoms and exacerbations. Salmeterol and theop hylline are indicated for the treatment of COPD, but the use of these agent s in combination has not been extensively studied. Objectives: To compare the efficacy and safety of salmeterol plus theophyll ine vs either agent alone in COPD, Methods: Randomized, double-blind, double-dummy, parallel-group trial in 94 3 patients with COPD. lifter an open-label theophylline titration period (s erum levels, 10 to 20 mug/mL), patients were randomly assigned to receive s almeterol (42 mug bid) plus theophylline, salmeterol (42 IJ g bid), or theo phylline for 12 weeks. Serial pulmonary function tests were completed on da y 1 and treatment week 12, Patients kept diary cards and noted their peak f low rates, symptom scores, and albuterol use, and periodically completed qu ality-of-life and dyspnea questionnaires. Results: All three groups significantly improved compared with baseline. Co mbination treatment with salmeterol plus theophylline provided significantl y (p less than or equal to 0.045) greater improvements in pulmonary functio n; significantly (p less than or equal to 0.048) greater decreases in sympt oms, dyspnea, and albuterol use; and significantly fewer COPD exacerbations (p = 0.023 vs theophylline), In general, treatment with salmeterol provide d greater improvement in lung function and satisfaction with treatment comp ared with theophylline, Salmeterol treatment was also associated with signi ficantly fewer drug-related adverse events (p less than or equal to 0.042) than either treatment that included theophylline, The safety profile (adver se events, vital signs, and ECG findings) of the two treatments that includ ed theophylline were similar. Conclusion: Patients with COPD may benefit from combination treatment with salmeterol plus theophylline without a resulting increase in adverse events or other adverse sequelae.