Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone

• Published in: The New England journal of medicine Vol. 375; no. 9; pp. 850 - 860
• Main Authors: Peters, Stephen P, Bleecker, Eugene R, Canonica, Giorgio W, Park, Yong B, Ramirez, Ricardo, Hollis, Sally, Fjallbrant, Harald, Jorup, Carin, Martin, Ubaldo J
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 01.09.2016
• Subjects: Administration, Inhalation; Adolescent; Adolescents; Adrenergic beta-2 Receptor Agonists - administration & dosage; Adrenergic beta-2 Receptor Agonists - adverse effects; Adult; Aged; Asthma; Asthma - drug therapy; Asthma - prevention & control; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Budesonide; Budesonide - administration & dosage; Budesonide - adverse effects; Child; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Female; Formoterol; Formoterol Fumarate - administration & dosage; Formoterol Fumarate - adverse effects; Glucocorticoids; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Humans; Inhalers; Intubation; Male; Middle Aged; Patient safety; Patients; Prospective Studies; Respiratory therapy; Safety; Young Adult; United States > US
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa1511190

In adolescents and adults with moderate-to-severe asthma, the addition of formoterol to inhaled glucocorticoids was associated with a lower risk of asthma exacerbations than that with glucocorticoids alone and with a similar risk of serious asthma-related events. Current guidelines for the management of asthma suggest that inhaled glucocorticoids should be used as initial controller therapy, with a long-acting beta-agonist (LABA) then added if symptoms remain uncontrolled or increase in severity. 1 Although LABAs have been an available treatment option for asthma since 1990, 2 questions remain regarding the safety of this drug class. 3 These concerns originate mainly from the results of two large studies in which the effects of adding the LABA salmeterol to existing asthma treatment were reviewed. 4 , 5 These studies showed higher rates of asthma-related death and other serious outcomes related to asthma among patients receiving salmeterol . . .