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http://hdl.handle.net/2445/178593
Title: | Serious asthma events with fluticasone plus salmeterol versus fluticasone alone |
Author: | Stempel, David A. Raphiou, Ibrahim H. Kral, Kenneth M. Yeakey, Anne M. Emmett, Amanda H. Prazma, Charlene Buaron, Kathleen S. Pascoe, Steven J. Lores Obradors, Luis AUSTRI Investigators |
Keywords: | Asma Broncodilatadors Ús terapèutic Asthma Bronchodilator agents Therapeutic use |
Issue Date: | 12-May-2016 |
Publisher: | Massachusetts Medical Society |
Abstract: | Background: the safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. Methods: in this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone-salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. Results: of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone-salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthma-related event in the fluticasone-salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P=0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthma-related intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone-salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone-salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P<0.001). Conclusions: patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group. (AUSTRI ClinicalTrials.gov number, NCT01475721). |
Note: | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1511049 |
It is part of: | New England Journal of Medicine, 2016, vol. 374, num. 19, p. 1822-1830 |
URI: | http://hdl.handle.net/2445/178593 |
Related resource: | https://doi.org/10.1056/NEJMoa1511049 |
ISSN: | 0028-4793 |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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