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dc.contributor.authorMagnussen, Helgo
dc.contributor.authorDisse, Bernd
dc.contributor.authorRodriguez-Roisin, Roberto
dc.contributor.authorKirsten, Anne
dc.contributor.authorWatz, Henrik
dc.contributor.authorTetzlaff, Kay
dc.contributor.authorTowse, Lesley
dc.contributor.authorFinnigan, Helen
dc.contributor.authorDahl, Ronald
dc.contributor.authorDecramer, Marc
dc.contributor.authorChanez, Pascal
dc.contributor.authorWouters, Emiel F. M.
dc.contributor.authorCalverley, Peter M. A.
dc.contributor.authorWISDOM Investigators
dc.date.accessioned2016-01-22T16:45:08Z
dc.date.available2016-01-22T16:45:08Z
dc.date.issued2014-09-08
dc.identifier.citationMagnussen et al. New England Journal of Medicine (2014) Vol. 371, pp. 1285-1294. doi: 10.1056/NEJMoa1407154en
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/253445
dc.descriptionThis is the final version of the article. It first appeared from Massachusetts Medical Society via http://dx.doi.org/10.1056/NEJMoa1407154en
dc.description.abstractBackground Treatment with inhaled glucocorticoids in combination with long-acting bronchodilators is recommended in patients with frequent exacerbations of severe chronic obstructive pulmonary disease (COPD). However, the benefit of inhaled glucocorticoids in addition to two long-acting bronchodilators has not been fully explored. Methods In this 12-month, double-blind, parallel-group study, 2485 patients with a history of exacerbation of COPD received triple therapy consisting of tiotropium (at a dose of 18 μg once daily), salmeterol (50 μg twice daily), and the inhaled glucocorticoid fluticasone propionate (500 μg twice daily) during a 6-week run-in period. Patients were then randomly assigned to continued triple therapy or withdrawal of fluticasone in three steps over a 12-week period. The primary end point was the time to the first moderate or severe COPD exacerbation. Spirometric findings, health status, and dyspnea were also monitored. Results As compared with continued glucocorticoid use, glucocorticoid withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95% confidence interval (CI) with respect to the first moderate or severe COPD exacerbation (hazard ratio, 1.06; 95% CI, 0.94 to 1.19). At week 18, when glucocorticoid withdrawal was complete, the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second was 38 ml greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group (P<0.001); a similar between-group difference (43 ml) was seen at week 52 (P=0.001). No change in dyspnea and minor changes in health status occurred in the glucocorticoid-withdrawal group. Conclusions In patients with severe COPD receiving tiotropium plus salmeterol, the risk of moderate or severe exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy. However, there was a greater decrease in lung function during the final step of glucocorticoid withdrawal.en
dc.description.sponsorshipSupported by Boehringer Ingelheim Pharma.en
dc.language.isoenen
dc.publisherMassachusetts Medical Societyen
dc.rightsAll Rights Reserveden
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved/en
dc.titleWithdrawal of Inhaled Glucocorticoids and Exacerbations of COPDen
dc.typeArticleen
dc.type.versionpublished versionen
prism.endingPage1294
prism.publicationDate2014
prism.publicationNameNew England Journal of Medicine
prism.startingPage1285
prism.volume371
pubs.declined2017-10-11T13:54:36.522+0100
rioxxterms.versionofrecord10.1056/NEJMoa1407154


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