The combination drug budesonide-formoterol is just as safe and even more effective for asthma treatment than budesonide alone, according to a postmarketing safety study required by the U.S. Food and Drug Administration (FDA) and published September 1, 2016 in the New England Journal of Medicine.
Previous studies have linked long-acting beta2-agonists with higher rates of asthma-related deaths and other serious outcomes. Consequently, the FDA now requires drug manufacturers whose products contain long-acting beta2-agonists to conduct postmarketing safety studies. In this trial, the combination therapy (marketed as Symbicort® by AstraZeneca) comprised budesonide, an inhaled glucocorticoid, with formoterol, a long-acting beta2-agonist.
“Our study showed no significant increase in serious adverse events in the combination therapy,” said lead author Stephen Peters, MD, PhD, Professor of Pulmonary, Critical Care, Allergy and Immunologic Diseases at Wake Forest Baptist Medical Center, in Winston-Salem, NC.
For this multicenter, double-blind study, the researchers randomly assigned a total of 11,693 patients with moderate to severe asthma to receive either budesonide-formoterol or budesonide alone. During the 6-month course of the study, 43 patients given the combination therapy had an asthma-related adverse event compared with 40 patients who received budesonide only. (Two asthma-related deaths occurred in the combination arm of the study and none in the single-therapy group, but these were considered not statistically significant.) Thus, the budesonide-formoterol combination showed no greater risk for asthma patients than budesonide alone.
The study also evaluated efficacy to assess the risks vs. benefits in the two treatment groups. Results showed that the risk of asthma exacerbation was 16.5% lower with budesonide-formoterol than with budesonide alone. “This significantly lower risk was observed despite the high percentage of patients reporting asthma control at baseline,” the authors wrote.
“A large number of studies have shown that this type of combination therapy really helps asthma control and decreases symptoms,” Dr. Peters said. “Our findings, in combination with results from another FDA-mandated safety study, are very reassuring to those of us who treat asthmatic patients.”
This study was funded by AstraZeneca.