Patient-Oriented Evidence That Matters
As-Needed Budesonide/Formoterol Similar to Maintenance Budesonide Plus SABA in Patients with Mild Asthma
Am Fam Physician. 2019 Nov 15;100(10):646-647.
For patients with mild asthma, is as-needed use of an inhaled steroid/long-acting beta-agonist as effective as either as-needed albuterol alone or as-needed albuterol plus daily use of an inhaled steroid?
In these patients with mild asthma (more than one-half used a short-acting beta-agonist [SABA] such as albuterol two or fewer times per week), as-needed use of a combined budesonide/formoterol (Symbicort) inhaler was as effective at preventing exacerbations as daily maintenance budesonide (Pulmicort) plus an as-needed SABA, and both were better than an as-needed SABA alone. The trial loses points for failing to mask outcome assessors and for having an imbalance in the number of previous severe exacerbations at baseline. (Level of Evidence = 1b–)
This study included patients with mild asthma who used a SABA alone at least twice in the previous three months, but no more than twice daily on average, and those who used a SABA alone and experienced a severe exacerbation in the past 12 months (7.3% of those enrolled). This raised the question of why a patient who had had a severe exacerbation (defined as requiring systemic corticosteroids or hospitalization) was being managed by a SABA alone. Patients hospitalized in the past 12 months were excluded. A total of 668 patients were randomized into one of three groups: (1) continued use of an as-needed SABA alone, (2) budesonide, 200 mcg twice daily, plus the SABA as needed, and (3) use of a combination inhaler containing 200 mcg of budesonide and 6 mcg of formoterol, one inhalation as needed to control symptoms. At baseline, there were some imbalances, with fewer women in the as-needed SABA group (50.7% vs. 55.5% to 57.3%), and more serious exacerbations in the past 12 months in the as-needed SABA group (20 vs. 17 for budesonide maintenance and only 12 for the budesonide/formoterol group). Analysis was by intention to treat, and only 13 patients were lost to follow-up during the one-year
Editor's Note: Dr. Ebell is Deputy Editor for Evidence-Based Medicine for AFP and cofounder and Editor-in-Chief of Essential Evidence Plus, published by Wiley-Blackwell.
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