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Controlled-Release Zileuton Tablets Shows Safety Profile Similar to Placebo: Presented at CHEST

By Ed Susman

SALT LAKE CITY, UT -- October 27, 2006 -- The investigative controlled-release (CR) oral agent zileuton appear to have a similar safety profile as placebo and as the immediate-release (IR) formulation of the drug that is being evaluated for treatment of chronic asthma, researchers said here at CHEST 2006, the 72^nd annual meeting of the American College of Chest Physicians.

"The overall incidence of adverse events reported in this study was similar in all treatment groups," said Leonard Bielory, MD, professor of medicine, New Jersey Medical School, Newark, New Jersey. "There were no clinically relevant differences between treatment groups in laboratory assessments, physical examinations or vital signs."

In the study, 206 patients were randomized to CR zileuton, 203 patients were assigned to CR placebo, 101 patients were assigned to IR zileuton, and 103 patients were given an IR placebo. The IR zileuton arm was included as a benchmark comparison with previous IR efficacy studies.

Efficacy of treatments was evaluated using patient's forced expiratory volume in 1 second (FEV₁).

After 12 weeks of treatment, the controlled-release formulation of zileuton had a statistically significant benefit in FEV₁ (P < .05), Dr. Bielory reported in his poster presentation October 25^th. There were no deaths in the study.

In the controlled-release comparison, the researchers found that 78.4% of patients on zileuton and 76.8% of patients on placebo had adverse events. Of all these reported events, 10 were judged to be of serious severity -- acute exacerbations of asthma. Three of these serious events occurred in the zileuton patients and 7 in the placebo group. None of the cases of asthma were judged to be caused by the study drug.

Dr. Bielory said liver enzyme elevations 3 times the upper limit of normal were seen in 5 patients on CR zileuton, 2 patients on IR zileuton and 1 placebo patient. "All the elevated liver enzyme elevations resolved to normal while patients continued to receive study drug or upon discontinuation of treatment," he stated. He said the incidence was similar to that seen in clinical studies with IR zileuton.

The study was sponsored by Critical Therapeutics, Lexington, Massachusetts.


[Presentation title: Safety of Zileuton Controlled-Release Tablets Given Twice Daily for the Treatment of Asthma: A Placebo-Controlled Study. Abstract 4033]

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