But, daily regimen leads to greater budesonide exposure than intermittent regimen in children
WEDNESDAY, Nov. 23 (HealthDay News) -- Daily low-dose budesonide therapy is not superior to intermittent high-dose therapy for reducing asthma exacerbations in children, according to a study published in the Nov. 24 issue of the New England Journal of Medicine.
Robert S. Zeiger, M.D., Ph.D., from Kaiser Permanente Southern California in San Diego, and colleagues investigated whether daily low-dose budesonide treatment was superior to an intermittent high-dose regimen in 278 children (aged 12 to 53 months), at risk for asthma exacerbations. Children with a positive modified asthma predictive index, recurrent wheezing episodes, at least one exacerbation in the preceding year, and a low degree of impairment, were randomly allocated to receive budesonide inhalation suspension for one year either as an intermittent high-dose (1 mg twice daily for one week, initiated during predefined respiratory tract illness) or as a daily low-dose regimen (0.5 mg/night), with corresponding placebos. The frequency of exacerbations requiring oral glucocorticoids was the main outcome measured.
The investigators found that the frequency of exacerbations did not differ significantly between the daily versus intermittent regimens, with the rate per patient-year of 0.97 (95 percent confidence interval [CI], 0.76 to 1.22) and 0.95 (95 percent CI, 0.75 to 1.20), respectively (relative rate in the intermittent-regimen group, 0.99; 95 percent CI, 0.71 to 1.35; P = 0.60). Measures of asthma severity, including the time to the first exacerbation, or adverse events did not differ significantly between the two groups. Compared with the daily regimen, the mean exposure to budesonide was 104 mg less with the intermittent regimen.
"The daily low-dose regimen was associated with more frequent administration of and greater exposure to budesonide," the authors write.
Budesonide and matching placebos for the study were donated by AstraZeneca; several authors disclosed financial relationships with pharmaceutical companies, including AstraZeneca.
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