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New indication: Budesonide/formoterol (Symbicort), a corticosteroid/LABA combination, was approved on February 27, 2009, for the maintenance treatment of COPD
This therapy consists of budesonide, an anti-inflammatory corticosteroid, and formoterol, a long-acting selective beta2-adrenergic agonist (LABA). This combination was approved on February 27, 2009, for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.
Efficacy. The efficacy of this therapy was evaluated in 2 randomized, double-blind, placebo-controlled studies. In Study 1, patients were randomized to 2 inhalations twice daily of budesonide/formoterol 160/4.5 mcg, budesonide/formoterol 80/4.5 mcg, budesonide 160 mcg plus formoterol 4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, or placebo. Over 6 months, budesonide/formoterol 160/4.5 mcg was associated with significantly greater mean improvements in predose forced expiratory volume in 1 second (FEV1) (10.7%) compared with formoterol 4.5 mcg (6.9%) or placebo (2.2%). Budesonide/formoterol 160/4.5 mcg was also associated with significantly greater mean improvements in 1-hour postdose FEV1 (22.6%) compared with budesonide 160 mcg (4.9%) or placebo (4.1%). In Study 2, patients were randomized to treatment with 2 inhalations twice daily of budesonide/formoterol 160/4.5 mcg, budesonide/formoterol 80/4.5 mcg, formoterol 4.5 mcg, or placebo. Budesonide/formoterol 160/4.5 mcg was associated with significantly greater improvements in mean predose FEV1 over 12 months (10.8%) compared with formoterol 4.5 mcg (7.2%) or placebo (2.8%). Budesonide/formoterol 160/4.5 mcg was also associated with significantly greater mean improvements in 1-hour postdose FEV1 (24.0%) compared with placebo (5.2%).
Safety. LABAs may increase the risk of asthma-related death. This therapy should not be initiated during rapidly deteriorating or life-threatening episodes of asthma or COPD. Patients treated with this agent have occasionally developed Candida albicans infections of the mouth and pharynx. Patients treated with corticosteroids are more susceptible to infection than healthy individuals. In patients transferred from systemically active corticosteroids to inhaled corticosteroids, deaths have occurred because of adrenal insufficiency. Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular adverse effects. The most frequently reported adverse events associated with this therapy include nasopharyngitis, oral candidiasis, bronchitis, and sinusitis.