Symbicort and budesonide monotherapy showed a comparable risk profile for serious asthma-related events in adolescents and adults with moderate-to-severe asthma, while the combination therapy yielded a lower risk for exacerbations, according to recently published data.
“Current guidelines for the management of asthma suggest that inhaled glucocorticoids should be used as initial controller therapy, with a [long-acting beta-agonist (LABA)] then added if symptoms remain uncontrolled or increase in severity,” Stephen P. Peters, MD, PhD, acting section chief of pulmonary, critical care, allergy and immunologic medicine at Wake Forest Baptist Health, and colleagues wrote. “Although LABAs have been an available treatment option for asthma since 1990, questions remain regarding the safety of this drug class.”
To assess the risk for asthma-related adverse events associated with Symbicort (budesonide/formoterol, AstraZeneca), Peters and colleagues conducted a multicenter, double blind, 26-week study of asthma-affected patients aged 12 years and older. Patients were randomly assigned budesonide/formoterol (n = 5,846) or budesonide monotherapy (n = 5,847).
Forty patients who received budesonide experienced serious asthma-related events vs. 43 patients in the budesonide/formoterol group (HR = 1.07; 95% CI, 0.7-1.65). Two asthma-related deaths occurred in the budesonide/formoterol group, including one patient who had undergone an asthma-related intubation. Overall, 9.2% of budesonide/formoterol patients reported 637 exacerbations, while 10.8% of patients in the budesonide monotherapy group reported 762 exacerbations (HR = 0.84; 95% CI, 0.74-0.94).
“Although the current study was designed primarily to assess safety, the evaluation of prespecified efficacy measures was included to further assess the benefit:risk profile of the treatment groups,” the researchers wrote. “The risk of asthma exacerbation, the primary efficacy variable, 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.” – by Kate Sherrer
Disclosure: The study was funded by AstraZeneca. Peters reports nonfinancial support from AstraZeneca during the conduct of this study, along with personal fees from Array Biopharma, Integrity CE, Aerocrine, Boehringer Ingelheim, Experts in Asthma, Gilead Sciences, GlaxoSmithKline, Merck, Ono Pharmaceuticals, Pfizer, PPD Development, Quintiles, Sunovion, Saatchi & Saatchi, Targacept, Teva, Theron, and Sanofi - Regeneron, and personal fees and other support from AstraZeneca and Novartis outside the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.