Long-acting beta-agonist combination therapy not linked with serious asthma events

A study of asthma patients found that the combination treatment budesonide/formoterol and budesonide alone produced a similar number of serious asthma-related events.

Stephen Peters, one of the authors of the study

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)[1]
. 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.

References

[1] Peters SP, Bleecker ER, Canonica GW et al. Serious asthma events with budesonide plus formoterol vs. budesonide alone. New England Journal of Medicine 2016;375:850–860. doi: 10.1056/NEJMoa1511190

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Citation
Clinical Pharmacist, CP, October 2016, Vol 8, No 10;8(10):DOI:10.1211/PJ.2016.20201694