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Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone.
- Source :
- Respiratory Medicine; Dec2007, Vol. 101 Issue 12, p2437-2446, 10p
- Publication Year :
- 2007
-
Abstract
- Summary: Background: Budesonide/formoterol maintenance and reliever therapy (Symbicort SMART<superscript>®</superscript>) improves asthma control compared with fixed-dose inhaled corticosteroid/long-acting β <subscript>2</subscript>-agonist (ICS/LABA) regimens, but its efficacy has not been assessed in comparison with sustained high-dose salmeterol/fluticasone (Seretide™) plus a short-acting β <subscript>2</subscript>-agonist (SABA). Methods: Patients (N=2309) with symptomatic asthma (aged ⩾12 years; forced expiratory volume in 1s ⩾50% predicted), who had experienced an asthma exacerbation in the previous year, were randomised to receive budesonide/formoterol 160/4.5μg two inhalations twice daily and as needed, or one inhalation of salmeterol/fluticasone 50/500μg twice daily plus terbutaline as needed, for 6 months. Results: Time to first severe exacerbation, the pre-specified primary outcome, was not significantly prolonged (risk ratio 0.82; 95% confidence interval 0.63, 1.05). Budesonide/formoterol maintenance and reliever therapy reduced total exacerbations from 31 to 25 events/100 patients/year (P=0.039), and exacerbations requiring hospitalisation/emergency room (ER) treatment from 13 to 9 events/100 patients/year (P=0.046). The treatments showed no difference in measures of lung function or asthma symptoms. The mean dose of ICS received was lower using budesonide/formoterol maintenance and reliever therapy (792μg/day budesonide [1238μg/day beclomethasone dipropionate (BDP) equivalent] versus 1000μg/day fluticasone [2000μg/day BDP equivalent] with salmeterol/fluticasone therapy; P<0.0001). Both treatments were well tolerated. Conclusion: In the treatment of uncontrolled asthma, budesonide/formoterol maintenance and reliever therapy reduces the incidence of severe asthma exacerbations and hospitalisation/ER treatment with similar daily symptom control compared with sustained high-dose salmeterol/fluticasone plus SABA. This benefit is achieved with substantially less ICS exposure. [Copyright &y& Elsevier]
Details
- Language :
- English
- ISSN :
- 09546111
- Volume :
- 101
- Issue :
- 12
- Database :
- Supplemental Index
- Journal :
- Respiratory Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 27228436
- Full Text :
- https://doi.org/10.1016/j.rmed.2007.07.014