Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/121999
Title: Withdrawal of inhaled glucocorticoids and exacerbations of COPD
Author: Magnussen, Helgo
Disse, Bernd
Rodriguez Roisin, Roberto
Kirsten, Anne
Watz, Henrik
Tetzlaff, Kay
Towse, Lesley
Finnigan, Helen
Dahl, Ronald
Decramer, Marc
Chanez, Pascal
Wouters, Emiel
Calverley, Peter M.
Keywords: Malalties pulmonars obstructives cròniques
Corticosteroides
Estudi de casos
Chronic obstructive pulmonary diseases
Adrenocortical hormones
Case studies
Issue Date: 1-Oct-2014
Publisher: Massachusetts Medical Society
Abstract: BACKGROUND 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. (Funded by Boehringer Ingelheim Pharma; WISDOM ClinicalTrials.gov number, NCT00975195.)
Note: Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1407154
It is part of: New England Journal of Medicine, 2014, vol. 371, p. 1285-1294
URI: http://hdl.handle.net/2445/121999
Related resource: https://doi.org/10.1056/NEJMoa1407154
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Medicina)

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