A post-marketing safety study mandated by the U.S. Food and Drug Administration has shown that a combination drug therapy for the treatment of asthma is safe and effective.
The therapy tested consisted of a long-acting beta agonist, formoterol, added to an inhaled glucocorticoid, budesonide.
“Our study showed no significant increase in serious adverse events in the combination therapy,” said Stephen Peters, M.D., Ph.D., professor of pulmonary, critical care, allergy and immunologic diseases at Wake Forest Baptist Medical Center and lead author of the study.
“A large number of studies have shown that this type of combination therapy really helps asthma control and decreases symptoms. Our findings, in combination with results from another FDA-mandated safety study, are very reassuring to those of us who treat asthmatic patients.”
The study is published in the Sept. 1 issue of the New England Journal of Medicine.
In this multicenter, double-blind, 26-week study, the scientists evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious asthma-related events in patients with moderate to severe asthma. Study participants were age 12 or older, had persistent asthma, received daily asthma medication and had one to four exacerbations in the previous year.
Of the 11,693 patients enrolled in the study, an asthma-related event occurred in 43 patients who received the combination therapy of budesonide and formoterol and in 40 patients who received only budesonide. Two asthma-related deaths were reported in the combination arm of the study and none in the single-therapy group, which is not statistically significant.
In addition, a secondary finding showed a 16.5 percent decrease in asthma exacerbations in the combination therapy group as compared to the group receiving budesonide.
Overall, the researchers found that treatment with budesonide-formoterol was associated with a lower risk of asthma exacerbations than budesonide and a similar risk of serious asthma-related events.
The study was funded by AstraZeneca, the maker of formoterol.
Co-authors are: Eugene R. Bleecker, M.D., of Wake Forest Baptist; Giorgio W. Canonica, M.D., of the University of Genoa, Genoa, Italy; Yong Bum Park, M.D., of Hallym University in Seoul, South Korea; Ricardo Ramireq, M.D., of Centro De Investigaciou Y Atencion Integral, Durango, Mexico; Sally Hollis, M.Sc., of AstraZeneca, Macclesfield, United Kingdom; Harald Fjallbrant, M.D., Ph.D., and Carin Jorup, M.D., of AstraZeneca Research and Development, Gothenburg, Sweden; and Ubaldo J. Martin, M.D., of AstraZeneca LP, Gaithersburg, MD.
Disclosure: Peters serves as a consultant for AstraZeneca, however he received no reimbursement from the company related to this study except for reimbursement for travel expenses to investigator meetings. Bleecker also is a consultant for AstraZeneca.
Marguerite Beck: firstname.lastname@example.org, 336-716-2415