What Is New In Small Airways Research
Ves Dimov, MD
Allergist/Immunologist at Cleveland Clinic
Clinical Associate Professor
FAU Charles E. Schmidt College of Medicine
Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone: no higher risk with the combo
Concerns remain about the safety of adding long-acting beta2-agonists to inhaled glucocorticoids for the treatment of asthma (ICS/LABA combo). These are the results of the post-marketing safety study mandated by the FDA, published in NEJM.
This multicenter, double-blind, 26-week study included 11,000 patients, 12 years of age or older, who had persistent asthma, and randomized them to receive budesonide–formoterol or budesonide alone.
The risk of an asthma exacerbation was 16.5% lower with budesonide–formoterol. Among adolescents and adults with moderate-to-severe asthma, treatment with budesonide–formoterol was associated with a lower risk of asthma exacerbations than budesonide and a similar risk of serious asthma-related events.
Source: Stephen PP, Bleecker ER, Canonica GW, Park YB, Ramirez R et al. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. The New England Journal of Medicine 2016; 375(9): 850-860. (doi:10.1056/NEJMoa1511190).
Image source: Wikipedia, Asthma, public domain.
Early-Life Origins of COPD - NEJM review
There has been a major change in our understanding of the natural history and risk factors for COPD, a frequent cause of illness and death. For example, in the United States, more people die from COPD than from any other condition except cancer and cardiovascular illnesses. Although smoking is still a major cause of COPD, genetic, environmental, and developmental factors both diminish the FEV1 and accelerate the FEV1 decline in adult life. Prevention of prematurity, and especially of bronchopulmonary dysplasia, is a major public health priority. Promising advances in the development of vaccines against respiratory syncytial virus and prevention strategies for childhood asthma could decrease the risk of COPD. Efforts to reduce exposure to air contaminants during pregnancy and childhood and to decrease adolescent smoking could also decrease the incidence of COPD.
Source: Martinez FD. Early-Life Origins of Chronic Obstructive Pulmonary Disease. The New England Journal of Medicine 2016; 375(9): 871-878. (doi:10.1056/NEJMra1603287)
Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma: no increase in risk
Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related hospitalization among children. This large study shows that the concomitant use of inhaled glucocorticoids with LABAs (ICS/LABA) mitigates those risks. The study was mandated by the Food and Drug Administration (FDA).
6,200 children, four to 11 years of age, who required daily asthma medications and had a history of asthma exacerbations in the previous year were randomized to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks.
Salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone.
Source: Stempel DA, Szefler SJ, Pedersen S, Zeiger RS, Yeakey AM et al. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. The New England Journal of Medicine 2016; 375(9): 840-849. (doi:10.1056/NEJMoa1606356).
Related editorial: Bush A and Frey U. Safety of Long-Acting Beta-Agonists in Children with Asthma. The New England Journal of Medicine 2016; 375(9): 889-891. (doi:10.1056/NEJMe1608508)