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Efficacy of Inhaled Fluticasone Plus Salmeterol in COPD



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Am Fam Physician. 2004 May 1;69(9):2239.

Chronic obstructive pulmonary disease (COPD), which is characterized by airflow limitation that is not fully reversible, affects a significant portion of Americans and is the fourth leading cause of death in the United States. Current treatment guidelines recommend bronchodilators as first-line therapy. Depending on the disease severity, inhaled corticosteroids may be added. Multiple studies examining the use of inhaled corticosteroids in patients with COPD have shown that corticosteroids have a positive impact on short-and long-term clinical outcomes. In addition, one study found that inhaled corticosteroids reduced COPD-related morbidity and mortality in elderly patients. Inhaled salmeterol has proved effective in improving lung function, symptoms, and quality of life in patients with COPD. Hanania and associates evaluated the efficacy and safety of a combination of fluticasone propionate and salmeterol in patients with COPD.

The randomized, double-blind, placebo-controlled, parallel-group, multicenter trial enrolled patients who had a diagnosis of COPD as defined by the American Thoracic Society and who met spirometry parameters. After a two-week run-in, patients were randomized to receive 250 mcg of fluticasone, 50 mcg of salmeterol, a combination of both agents, or placebo delivered twice daily through a single device for 24 weeks. Treatment efficacy was assessed by measuring forced expiratory volume in one second (FEV1) before and two hours after medication use. Other measures assessed included morning peak expiratory flow (PEF), dyspnea symptoms, supplemental albuterol use, health status, symptoms of chronic bronchitis, and exacerbation of symptoms. Safety was evaluated by recording adverse events, electrocardiogram readings, vital signs, clinical laboratory tests, oropharyngeal examinations and, in some centers, results of a cosyntropin-stimulation test.

Compared with placebo or salmeterol alone, the combination of fluticasone and salmeterol significantly increased pre-dose FEV1. The combination treatment also significantly improved the two-hour post-dose FEV1 compared with placebo and fluticasone alone. Lung function as measured by morning PEF improved with the fluticasone/salmeterol combination. Compared with placebo, the combination significantly improved dyspnea, quality of life, and symptoms of bronchitis. Adverse events were similar between the four treatment groups, except for oral candidiasis, which was higher in the combination and fluticasone-only groups.

The authors conclude that a combination of fluticasone and salmeterol twice daily substantially improves lung function in patients with COPD compared with either medication alone over a 24-week period. They note that the combination therapy does not increase adverse events compared with use of individual agents.

Hanania NA, et al. The efficacy and safety of fluticasone propionate (250 g)/salmeterol (50 g) combined in the Diskus inhaler for the treatment of COPD. Chest. September 2003;124:834–43.



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