Zileuton Provided Clinically Relevant Reductions in the Need for Rescue Medication and Oral Corticosteroids Compared to Placebo in Moderate and Severe Asthmatics.
This was a previously published, randomized, placebo-controlled, double-blind, parallel, multi-center six-month study of the safety and efficacy of zileuton (400 or 600 mg QID) in 373 patients with asthma on no chronic asthma treatment other than beta-agonists (J Allergy Clin Immunol 1996; 98(5):859-71). Assessments included beta-agonist use, acute asthma exacerbations requiring alternative treatment or oral corticosteroids, and daily and nocturnal symptoms, as well as mean FEV1 and other pulmonary function tests.In an exploratory secondary analysis of patients in the high dose zileuton 600 mg QID group, patients were stratified by baseline (BL) percent predicted FEV1 into two subgroups of asthma severity: moderate (>60%-<80%) and severe (≤60%).
Moderate and severe zileuton patients reported reduced daily number of occasions of beta-agonist use. Fewer zileuton patients experienced asthma exacerbations requiring alternative treatment and oral corticosteroid treatment. Improvements in daily and nocturnal symptoms were also reported. These differences were sustained throughout the six-month study.
In severe asthmatic patients, Zileuton, 600 mg QID, provided significant improvement versus placebo in markers of asthma control including reductions in daily number of occasions of beta-agonist use, asthma exacerbations.
Zileuton, a 5-lipoyxgenase inhibitor approved for the treatment of chronic asthma, may reduce the need for beta-agonists and oral corticosteroids and improve other markers of asthma control, especially in severe asthmatics.
Mark Liu, None.Severity GroupMean Change From BL to Days 163-190 in Beta-Agonist Use (Number of Occasions/Day)Patients With Exacerbations Requiring Alternative Treatment (%)Patients Requiring Oral Corticosteroids (%)ZileutonPlaceboZileutonPlaceboZileutonPlaceboModerate (n=133)-0.70-0.4013.6%+26.5%9.1%17.7%Severe (n=98)-0.85**+0.167.8%*23.4%5.9%**25.5%