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

被引：20
|
作者：
Wenzel, Sally
Busse, William
Calhoun, William
Panettieri, Reynold, Jr.
Peters-Golden, Mark
Dube, Louise
Walton-Bowen, Karen
Russell, Heidy
Harris, Judith
机构：
[1] Univ Pittsburgh, Pittsburgh, PA USA
[2] Univ Wisconsin, Madison, WI USA
[3] Univ Texas, Med Branch, Galveston, TX USA
[4] Univ Penn, Philadelphia, PA 19104 USA
[5] Univ Michigan, Ann Arbor, MI 48109 USA
[6] Pleiades Consultat Inc, Scottsdale, AZ USA
[7] Crit Therapeut Inc, Lexington, MA USA
[8] PROMETRIKA Inc, Cambridge, MA USA
来源：
JOURNAL OF ASTHMA | 2007年 / 44卷 / 04期
关键词：
zileuton; asthma; adjunctive therapy; controlled-release;
D O I：
10.1080/02770900701344199
中图分类号：
R392 [医学免疫学];
学科分类号：
100102 ;
摘要：
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.
引用
收藏
页码：305 / 310
页数：6
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