Despite being available for several decades, uncertainty remains about the safety of adding long-acting beta-agonists (LABAs) to inhaled glucocorticoid treatment for asthma; some studies have found an increased risk of adverse outcomes, including asthma-related death.
Following a request from the US Food and Drug Administration, AstraZeneca conducted a randomised post-marketing study comparing fixed-dose budesonide/formoterol (Symbicort) with budesonide alone in 11,693 patients with persistent asthma aged 12 years and over.
A similar proportion of patients in each group experienced a serious asthma-related event during the 26-week study (0.74% vs 0.68%; budesonide/formoterol vs budesonide), according to the results published in the New England Journal of Medicine (online, 1 September 2016)
. Combined treatment was associated with a 16.5% reduced risk of exacerbations.
The findings provide important information on the risk-benefit profile of LABAs in combination with inhaled glucocorticoids, the authors conclude.