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Asthma Events with Budesonide plus Formoterol

N Engl J Med; 2016 Sep 1; Peters, Bleecker, et al

Publish date:

Treatment with budesonide plus formoterol was associated with a lower risk of asthma exacerbations than budesonide alone and a similar risk of serious asthma-related events among adolescents and adults with predominantly moderate-to-severe asthma, a recent study found. In this double-blind, 26-week study, a total of 11,693 patients aged ≥12 years who had persistent asthma, were receiving daily asthma medication, and had 1 to 4 asthma exacerbations in the previous year underwent randomization to budesonide-formoterol (n=5,846) or budesonide alone (n=5,847). Researchers found:

• 43 patients receiving budesonide-formoterol and 40 patients receiving budesonide alone experienced a serious asthma-related event (HR, 1.07).

• There were 2 asthma-related deaths, both in the budesonide-formoterol group.

• The risk of an asthma exacerbation was 16.5% lower with budesonide-formoterol vs budesonide alone (HR, 0.84).

Citation: Peters SP, Bleecker ER, Canonica GW, et al. Serious asthma events with budesonide plus formoterol vs budesonide alone. N Engl J Med. 2016;375:850-860. doi:10.1056/NEJMoa1511190.

Commentary: The use of combination long-acting beta agonists (LABAs)/inhaled corticosteroids (ICS) for patients with uncontrolled asthma gives significant symptomatic benefit compared to the use of an inhaled corticosteroid alone along with a decrease in the rate of exacerbations.1 For years, we have known that the use of LABAs alone increases the risk of severe exacerbations in both adults and children and so the use of LABA monotherapy has been contraindicated in asthma. What has remained a question is whether the addition of an ICS to a LABA offsets the increased risk that occurs with use LABAs alone. The 2 studies (also see “Is Salmeterol Added to Fluticasone Safe in Children?” study in this issue) are important additions to the literature on the treatment of asthma with combination therapy. The study of budesonide/formoterol (Symbicort) demonstrates both decreased exacerbations as well as the safety of combination therapy in those >12 years of age. The study of salmeterol/fluticasone (Advair) extends the results of a previous study with this combination in adults,2 to a pediatric age group. Together, these 2 studies provide a great deal of reassurance about the safety and efficacy of combination LABA/ICS treatment. —Neil Skolnik, MD

1. Scicchitano R, Aalbers R, Ukena D, et al. Efficacy and safety of budesonide/ formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin. 2004; 20:1403-18. doi:10.1185/030079904X2051.

2. Stempel DA, Raphiou IH, Kral KM, et al. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med. 2016;374:1822-30. doi:10.1056/NEJMoa1511049.

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