Montelukast Effectively Treats the Nighttime Impact of Seasonal Allergic Rhinitis

氯雷他定 孟鲁卡斯特 医学 安慰剂 鼻塞 置信区间 生活质量(医疗保健) 内科学 随机对照试验 哮喘 麻醉 外科 替代医学 护理部 病理 鼻子
作者
Eli O. Meltzer,George Philip,Steven F. Weinstein,Craig LaForce,Marie‐Pierre Malice,Sairia Dass,Nancy C. Santanello,Theodore F. Reiss
出处
期刊:American Journal of Rhinology [SAGE]
卷期号:19 (6): 591-598 被引量:17
标识
DOI:10.1177/194589240501900611
摘要

Nighttime problems constitute a significant burden on the quality of life of patients with seasonal allergic rhinitis (SAR). The aim of this study was to evaluate the effectiveness of montelukast on nighttime AR symptoms.In seven multicenter, double-blind, parallel-group trials, nighttime problems were assessed as the nighttime symptoms score (NSS), an average of three individual symptom scores: difficulty going to sleep, nighttime awakening, and nasal congestion on awakening (each rated 0 = none to 3 = severe). Patients (aged 15-82 years) were randomized to receive montelukast, 10 mg (n = 1751), placebo (n = 1557), or the positive control loratadine, 10 mg (n = 1616).In a combined analysis, changes from baseline (mean +/- SE) in NSS were -0.28 +/- 0.01, -0.16 +/- 0.01, and -0.24 +/- 0.01 for the montelukast, placebo, and loratadine groups, respectively. Difference versus placebo in least-squares mean change from baseline were -0.11 (95% confidence interval, -0.14, -0.08; p < or = 0.001) for montelukast and -0.09 (-0.12, -0.06; p < or = 0.001) for loratadine. Strong baseline correlations (R > 0.70; p < 0.001) of NSS and two of its individual symptoms with the sleep domain of the validated Rhinoconjunctivitis Quality of Life Questionnaire support the validity and importance of measuring nighttime morbidity in SAR. Furthermore, a clinically important benefit of montelukast on the nighttime impact of SAR was shown using an analysis anchored on the Patient's Global Evaluation.These data underscore the importance of nighttime problems in patients with SAR and the need to treat nighttime symptoms. In these studies, montelukast significantly improved the NSS, a clinically relevant and valid measure in patients with SAR.
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