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Montelukast, a Leukotriene Receptor Antagonist, in Combination With Loratadine, a Histamine Receptor Antagonist, in the Treatment of Chronic Asthma

2000; American Medical Association; Volume: 160; Issue: 16 Linguagem: Inglês

10.1001/archinte.160.16.2481

1538-3679

Alise Reicin,

Mast cells and histamine

Background: Montelukast sodium, a potent, oral, specific leukotriene-receptor antagonist, has demonstrated clinical efficacy in the treatment of chronic asthma.Loratadine, a selective histamine type 1 (H 1 )-receptor antagonist, has demonstrated antiallergic properties.Leukotriene-receptor antagonists given concomitantly with H 1 -receptor antagonists have been shown to have additive effects in the prevention of bronchospasm in antigenchallenge models.Objective: To determine whether montelukast plus loratadine provides improved efficacy to montelukast alone in the treatment of chronic asthma. Methods:The efficacy of montelukast alone vs montelukast-loratadine was studied in a 10-week, multicenter, randomized, double-blind, 2ϫ2 crossover study.After a 2-week placebo run-in period, patients received montelukast sodium (10 mg) plus loratadine (20 mg), or montelukast sodium (10 mg ) plus placebo once daily for 2 weeks.After a 2-week placebo washout period, patients were crossed over to receive 2 weeks of the other active treatment regimen, followed by another 2-week placebo washout period.Results: Montelukast given concomitantly with loratadine caused significant improvement in percentage of change from baseline in forced expiratory volume in 1 second (FEV 1 ) compared with montelukast alone (13.86% vs 9.72%; P=.001).The average additional effect of loratadine (least square mean difference in percentage of change from baseline in FEV 1 ) was 4.15% (95% confidence interval, 1.65%-6.65%).Key secondary end points (mean daily ␤-agonist use, daytime and nighttime symptom scores, morning and evening peak expiratory flow rate, and the Patient Global Evaluation) all showed significant improvement with montelukast-loratadine (PϽ.05). Conclusion:Montelukast-loratadine significantly improved end points of asthma control during a 2-week treatment period.