SALMETEROL IMPROVES QUALITY-OF-LIFE IN PATIENTS WITH ASTHMA REQUIRINGINHALED CORTICOSTEROIDS

Background: Traditional clinical outcomes have demonstrated that salme terol improves pulmonary function and reduces asthma symptoms. However , they do not evaluate how patients perceive the effect of therapeutic intervention on day-to-day functioning and well-being. Objective: We sought to evaluate the impact of salmeterol on disease-specific qualit y of life with the Asthma Quality-of-Life Questionnaire, as well as th e efficacy and safety of salmeterol in patients with stable asthma who were symptomatic despite daily use of inhaled corticosteroids. Method s: This was a randomized, double-blind, placebo-controlled, parallel-g roup study of 506 patients. Patients were treated with 42 mu g salmete rol or placebo twice daily for 12 weeks delivered through a metered do se inhaler. Results: Mean change from baseline in asthma quality-of-li fe scores was significantly greater (p less than or equal to 0.006) af ter 12 weeks of treatment with salmeterol compared with placebo (''as- needed'' albuterol) in global scores (1.08 vs 0.61) and individual dom ains (activity limitations, 0.91 vs 0.54; asthma symptoms, 1.28 vs 0.7 1; emotional function, 1.17 vs 0.65; and environmental exposure, 0.84 vs 0.47). Patients treated with salmeterol experienced significantly g reater improvements from baseline to week 12 compared with placebo in FEV1 (0.42 L vs 0.15 L, p < 0.001), morning peak expiratory flow (47 L /min vs 14 L/min, p < 0.001), evening peak expiratory flow (29 L/min v s 11 L/min, p < 0.001), and asthma symptom scores (daytime scores redu ced by 0.55 vs 0.30, p < 0.001). Patients treated with salmeterol used significantly less supplemental albuterol (reduced by 3 puffs/day vs 1 puff/day, p < 0.001). Conclusion: Salmeterol provided significantly greater improvement in quality-of-life outcomes in patients whose asth ma symptoms are not well controlled with inhaled corticosteroids. Thes e results demonstrate that the benefits of salmeterol are not limited to conventional clinical measures of efficacy.