Literature

Clinical Pearls & Morning Reports


By Carla Rothaus

Published May 16, 2018

res360

How does as-needed budesonide–formoterol compare to budesonide maintenance for decreasing the rate of severe exacerbations in patients with mild asthma?

Mild asthma often remains poorly controlled despite the availability of effective treatments. Bateman et al. conducted the SYGMA 2 trial to examine whether budesonide–formoterol used as needed would be noninferior to regular budesonide maintenance treatment (with terbutaline used as needed) in preventing severe exacerbations in patients with mild asthma. Read the latest NEJM Original Article here.

Clinical Pearls

Q: How satisfactory is adherence to regular controller therapy among patients with mild asthma?

A: Current guidelines recommend that most patients with mild asthma be treated with regular, low-dose inhaled glucocorticoids as controller medication to reduce the risk of exacerbations, with short-acting β2-agonists (SABAs) used as needed for symptom relief. The underuse of inhaled glucocorticoids, even in patients with mild asthma, is associated with severe asthma exacerbations and death. However, adherence to regular controller therapy, particularly inhaled glucocorticoids, is poor. Instead, patients rely on SABAs to relieve symptoms, and overuse is common. This behavior is also associated with a risk of severe exacerbations and death.

Q: How much lower might the daily dose of inhaled glucocorticoids be among patients using as-needed budesonide–formoterol rather than budesonide maintenance therapy?

A: In the SYGMA 2 trial, the median daily dose of inhaled glucocorticoid was 75% lower in the budesonide–formoterol group than in the budesonide maintenance group (metered dose, 66 μg and 267 μg, respectively).

Morning Report Questions

Q: How does as-needed budesonide–formoterol compare to budesonide maintenance therapy for decreasing the rate of severe exacerbations in patients with mild asthma?

A: In the trial by Bateman et al., the primary objective was to evaluate whether budesonide–formoterol used as needed was noninferior to budesonide maintenance therapy in terms of the annualized rate of severe exacerbations. The trial showed that budesonide–formoterol used as needed was noninferior to budesonide maintenance therapy; the annualized rate of severe asthma exacerbations was 0.11 (95% confidence interval [CI] 0.10 to 0.13) in the budesonide–formoterol group and 0.12 (95% CI, 0.10 to 0.14) in the budesonide maintenance group. There was no significant difference between the two treatment groups in the time to the first severe asthma exacerbation, nor was there a significant difference in the rate of severe exacerbations according to pretrial treatment.

Q: Did the results for any of the outcomes in the trial by Bateman et al. favor budesonide maintenance therapy over as-needed budesonide-formoterol?

A: Improvements in secondary end points reflecting control of asthma symptoms (according to the Asthma Control Questionnaire–5) and quality of life (according to the Asthma Quality of Life questionnaire) and the forced expiratory volume in 1 second (FEV1) before bronchodilator use were larger with budesonide maintenance therapy than with budesonide–formoterol used as needed.

Browse more Clinical Pearls & Morning Reports »

NEJM Knowledge+