David J. Amrol, MD reviewing Peters SP et al. N Engl J Med 2016 Sep 1.

The LABA formoterol, added to budesonide, didn't cause excess serious asthma-related adverse events.

Asthma guidelines recommend adding a long-acting β-agonist (LABA) when asthma is not controlled with low-dose inhaled corticosteroids (ICS).* However, whether concomitant use of ICS mitigates the known risk for excess asthma-related deaths associated with LABA use is unclear (NEJM JW Gen Med Mar 1 2006 and Chest 2006; 129:15). The FDA asked manufacturers to conduct large studies to assess the safety of LABAs when used as an add-on therapy to ICS.

In this 26-week, industry-supported, randomized trial, researchers enrolled 11,693 adolescents and adults (age, ≥12) who had persistent asthma and one to four exacerbations in the previous year (but no previous life-threatening asthma events). Patients received twice-daily treatment with single inhalers that contained the ICS budesonide plus either formoterol (Symbicort) or placebo. The primary safety endpoint of serious asthma-related events (death, intubation, or hospitalization) was similar in both groups, but the primary efficacy endpoint of asthma exacerbations requiring systemic steroids was significantly less common in the formoterol group than in the placebo group (637 vs. 762 events). Serious asthma-related events occurred in 43 formoterol patients (including 2 deaths) and in 40 placebo patients (no deaths).

CITATION(S):

Peters SP et al. Serious asthma events with budesonide plus formoterol vs. budesonide alone. N Engl J Med 2016 Sep 1; 375:850.

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