Jp. Kemp et al., Zafirlukast in clinical practice - Results of the Accolate Clinical Experience and Pharmacoepidemiology Trial (ACCEPT) in patients with asthma, J FAM PRACT, 48(6), 1999, pp. 425-432
BACKGROUND. Zafirlukast is an oral leukotriene receptor antagonist used in
the treatment of patients with mild to moderate asthma. To investigate its
effects in a clinical practice setting, we evaluated zafirlukast in a heter
ogeneous group of patients who had asthma of different degrees of severity
and who were receiving concomitant asthma medications.
METHODS. A total of 3759 patients were enrolled at 924 sites. Patients rece
ived zafirlukast 20 mg twice a day for 4 weeks. Pulmonary function was meas
ured twice a day, and overall asthma symptom scores, number of nighttime aw
akenings, severity of morning asthma symptoms, and beta(2)-agonist use were
recorded daily.
RESULTS. In the efficacy analysis (3207 evaluable patients), all parameters
showed statistically significant improvement that continued throughout the
4 weeks of the trial. A total of 71% of patients had improved pulmonary fu
nction and 72% had improved asthma symptoms. Improvement was consistent reg
ardless of asthma severity category and regardless of concomitant asthma me
dication category. More than 70% of both physicians and patients indicated
there was clinical improvement in pulmonary measures as well as in asthma s
ymptoms. Common adverse events reported were headache (3.7%), nausea (1.4%)
, pharyngitis (1.4%), and sinusitis (1.1%).
CONCLUSIONS. Zafirlukast 20 mg twice a day is well tolerated and improves p
ulmonary function and asthma symptoms, regardless of asthma severity catego
ry and regardless of concomitant asthma medication category.