Fluticasone propionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast

[摘要] Background: Asthma is a disease of chronic inflammation and bronchoconstriction. Inhaled corticosteroids (ICSs) provide important anti-inflammatory treatment but may not provide optimal control of asthma when taken alone. Two therapeutic alternatives for enhanced asthma control are to substitute the combination of fluticasone propionate (FP) and salmeterol (FP/Salm Combo) through the Diskus inhaler or to add montelukast to existing ICS therapy Objective: We compared the efficacy and safety of FP/Salm Combo through the Diskus inhaler versus montelukast added to FP (FP + montelukust) in patients whose symptoms were suboptimally controlled with ICS therapy. Methods: We performed a multicenter, double-blind, double-dummy, parallel-group, 12-week study in 447 patients dth asthma who were symptomatic at baseline while receiving low-dose FP, Patients were treated for 12 weeks,vith one of the following: (1) combination of FP 100 mug plus salmeterol 50 mug twice daily through the Diskus inhaler, or (2) EP 100 mug twice daily through the Diskus inhaler plus oral montelukast 10 mg once daily, Results: FP/Salm Combo treatment provided better overall asthma control than FP + montelukast with significantly greater improvements in morning peak expiratory flow (+24.9 L/min vs +13.0 L/min, P < .001), evening peak expiratory flew (+18.9 L/min vs +9.6 L/min, P < .001), and forced expiratory volume in 1 second (+0.34 L vs +0.20 L, P < .001), as well as a change in the percentage of days with no albuterol use (+26.3 % vs +19.1%, P = .032) and the shortness of breath symptom score (-0.56 vs -0.40, P = .017). The groups had comparable improvements in chest tightness, wheeze, and overall symptom scores. Asthma exacerbation rates were significantly lower (P = .031) in the FP/Salm Combo group (4 patients, 2%) than in the FP + montelukast group (13 patients, 6%). Adverse event profiles were comparable. Conclusion: Symptomatic patients on low-dose ICS therapy had significantly greater improvement in asthma control when switched to the FP/Salm Combo than when montelukast was added to ICS therapy.

[发布日期] 2000-12-01

[关键词] asthma;Advair;salmeterol;fluticasone propionate;leukotriene modifiers;montelukast;combination therapy;Seretide