Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/178593
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Stempel, David A. | - |
dc.contributor.author | Raphiou, Ibrahim H. | - |
dc.contributor.author | Kral, Kenneth M. | - |
dc.contributor.author | Yeakey, Anne M. | - |
dc.contributor.author | Emmett, Amanda H. | - |
dc.contributor.author | Prazma, Charlene | - |
dc.contributor.author | Buaron, Kathleen S. | - |
dc.contributor.author | Pascoe, Steven J. | - |
dc.contributor.author | Lores Obradors, Luis | - |
dc.contributor.author | AUSTRI Investigators | - |
dc.date.accessioned | 2021-06-18T07:27:05Z | - |
dc.date.available | 2021-06-18T07:27:05Z | - |
dc.date.issued | 2016-05-12 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/178593 | - |
dc.description.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). | - |
dc.format.extent | 9 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1511049 | - |
dc.relation.ispartof | New England Journal of Medicine, 2016, vol. 374, num. 19, p. 1822-1830 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1511049 | - |
dc.rights | (c) Massachusetts Medical Society, 2016 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Asma | - |
dc.subject.classification | Broncodilatadors | - |
dc.subject.classification | Ús terapèutic | - |
dc.subject.other | Asthma | - |
dc.subject.other | Bronchodilator agents | - |
dc.subject.other | Therapeutic use | - |
dc.title | Serious asthma events with fluticasone plus salmeterol versus fluticasone alone | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 663151 | - |
dc.date.updated | 2021-06-17T16:30:22Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 26949137 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
663151.pdf | 242.65 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.