Clinical Studies A total of 5542 patients have been exposed to zileuton in clinical trials , 2252 of them for greater than 6 months and 742 for greater than 1 year. Adverse events most frequently occurring (frequency = 3%) in ZYFLO-treated patients and at a frequency greater than placebo-treated patients are summarized in Table 2. TABLE 2 Proportion of Patients Experiencing Adverse Events in Placebo-Controlled Studies in Asthma BODY SYSTEM/Event ZYFLO 600 mg 4 times daily % Occurrence (N = 475) Placebo % Occurrence (N = 491) BODY AS A WHOLE Headache 24.6 24.0 Pain (unspecified) 7.8 5.3 Abdominal Pain 4.6 2.4 Asthenia 3.8 2.4 Accidental Injury 3.4 2.0 DIGESTIVE SYSTEM Dyspepsia 8.2* 2.9 Nausea 5.5 3.7 MUSCULOSKELETAL Myalgia 3.2 2.9 *p = 0.05 vs placebo constipation , dizziness , fever , flatulence , hypertonia , insomnia , lymphadenopathy , malaise , neck pain/rigidity, nervousness, pruritus , somnolence , urinary tract infection , vaginitis , and vomiting. The frequency of discontinuation from the asthma clinical studies due to any adverse event was comparable between ZYFLO (9.7%) and placebo-treated (8.4%) groups. In placebo-controlled clinical trials, the frequency of ALT elevations = 3xULN was 1.9% for ZYFLO-treated patients, compared with 0.2% for placebo-treated patients. In controlled and uncontrolled trials, one patient developed symptomatic hepatitis with jaundice , which resolved upon discontinuation of therapy. An additional 3 patients with
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