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
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
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,
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