The Safety and Efficacy of Zileuton Controlled-Release Tablets as Adjunctive Therapy to Usual Care in the Treatment of Moderate Persistent Asthma: A 6-Month Randomized Controlled Study

• Published in: The Journal of asthma 2007-05, Vol.44 (4), p.305-310
• Main Authors: Wenzel, Sally, Busse, William, Calhoun, William, Panettieri, Reynold, Peters-Golden, Mark, Dube, Louise, Walton-Bowen, Karen, Russell, Heidy, Harris, Judith
• Format: Article
• Language: English
• Subjects: adjunctive therapy; Adolescent; Adrenergic beta-Agonists - therapeutic use; Adult; Aged; Aged, 80 and over; asthma; Asthma - drug therapy; Child; controlled-release; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Glucocorticoids - therapeutic use; Humans; Hydroxyurea - administration & dosage; Hydroxyurea - adverse effects; Hydroxyurea - analogs & derivatives; Hydroxyurea - therapeutic use; Lipoxygenase Inhibitors - administration & dosage; Lipoxygenase Inhibitors - adverse effects; Lipoxygenase Inhibitors - therapeutic use; Male; Middle Aged; Peak Expiratory Flow Rate; Quality of Life; Tablets; zileuton
• ISSN: 0277-0903; 1532-4303
• DOI: 10.1080/02770900701344199

This study was conducted to assess the safety and efficacy of zileuton controlled release [CR] 1,200 mg BID added to usual care (UC) in 926 patients with moderate asthma (619 patients randomized to zileuton CR and 307 to placebo). Sustained improvements in AM and PM peak expiratory flow (PEF) were observed in the zileuton CR group compared to placebo. The adverse event profile was similar in the two treatment groups. Eleven patients (1.8%) receiving zileuton CR and 2 (0.7%) receiving placebo experienced elevations of alanine aminotransferase (ALT) ≥ 3X the upper limit of normal (ULN). These elevations typically occurred (81.8%) during the first 3 months of exposure and most resolved within 21 days after discontinuation.