Purpose of the Study. Both inhaled glucocorticosteroids and sodium cromoglycate are recommended as first-line maintenance drugs for the control of persistent asthma. The objective of this study was to compare the cost-effectiveness of these 2 treatment strategies in everyday clinical practice.
Study Population. Children, 5 to 11 years old, with mild to moderate persistent asthma not previously treated with inhaled steroids or cromones.
Methods. The children were recruited from 10 secondary care centers in Sweden. The study was performed as a randomized, parallel-group, open-label pharmacoeconomic clinical trial. After the asthma was first stabilized using 4 to 6 weeks of inhaled budesonide, the children received either budesonide 200 to 400 μg twice daily (N = 69) or sodium cromoglycate 20 mg 3 times a day (N = 69) as maintenance therapy for 12 months. To better simulate normal clinical practice, investigators were instructed to maintain asthma control with normal procedures, including the ability to switch patients from one study treatment to the other, use additional therapy when required, or alter dosages as needed. Direct health care consumption costs and indirect costs attributable to loss of productivity by the family were recorded along with lung function and asthma symptoms.
Results. Twenty-nine children (42%) in the cromoglycate arm were switched to budesonide, with 24 (35%) attributable to lack of effect. Despite this, budesonide treatment resulted in a 24% lower annual cost than in those treated with cromoglycate. This trend was not statistically significant. Most of the reduction reflected the direct cost of medication with cromoglycate more than double the daily cost of budesonide. No statistically significant differences were noted in peak flow rate, symptoms, albuterol use or exacerbation rates, although budesonide was superior in almost all categories. However, there was a significant 14% increase in the number of symptom-free days after the change to budesonide from cromoglycate.
Conclusion. The study demonstrates that budesonide resulted in lower costs and less drug switches than a maintenance treatment strategy using sodium cromoglycate.
Reviewers’ Comments. This important long-term study suggests that an inhaled corticosteroid in asthmatic children not only results in lower costs than cromoglycate, but is more effective over a 12-month period. This is supported by the striking findings of the large number (35%) of children who had to switch from cromoglycate to budesonide because of inadequate control. The lack of statistical significance of several of the clinical and economic parameters may be a reflection of the rather small numbers compared and the fact that those remaining in the cromoglycate group were less severe.
- Copyright © 2002 by the American Academy of Pediatrics