Science News
from research organizations

Combination drug therapy for asthma patients is safe, study shows

Date:
August 31, 2016
Source:
Wake Forest Baptist Medical Center
Summary:
A post-marketing safety study mandated by the US Food and Drug Administration has shown that a combination drug therapy for the treatment of asthma is safe and effective.
Share:
FULL STORY

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.


Story Source:

Materials provided by Wake Forest Baptist Medical Center. Note: Content may be edited for style and length.


Journal Reference:

  1. Stephen P. Peters, Eugene R. Bleecker, Giorgio W. Canonica, Yong B. Park, Ricardo Ramirez, Sally Hollis, Harald Fjallbrant, Carin Jorup, Ubaldo J. Martin. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. New England Journal of Medicine, 2016; 375 (9): 850 DOI: 10.1056/NEJMoa1511190

Cite This Page:

Wake Forest Baptist Medical Center. "Combination drug therapy for asthma patients is safe, study shows." ScienceDaily. ScienceDaily, 31 August 2016. <www.sciencedaily.com/releases/2016/08/160831223824.htm>.
Wake Forest Baptist Medical Center. (2016, August 31). Combination drug therapy for asthma patients is safe, study shows. ScienceDaily. Retrieved May 24, 2017 from www.sciencedaily.com/releases/2016/08/160831223824.htm
Wake Forest Baptist Medical Center. "Combination drug therapy for asthma patients is safe, study shows." ScienceDaily. www.sciencedaily.com/releases/2016/08/160831223824.htm (accessed May 24, 2017).

RELATED STORIES