help button home button
AJRCCM
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH
Published ahead of print on October 4, 2007, doi:10.1164/rccm.200707-973OC

Am. J. Respir. Crit. Care Med., Volume 177, Number 1, January 2008, 19-26

A more recent version of this article appeared on January 1, 2008
This Article
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
200707-973OCv1
177/1/19    most recent
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Wedzicha, J. A
Right arrow Articles by Stockley, R. A
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Wedzicha, J. A
Right arrow Articles by Stockley, R. A

Submitted on July 2, 2007
Accepted on October 4, 2007

The Prevention of COPD Exacerbations by Salmeterol/Fluticasone Propionate or Tiotropium Bromide

Jadwiga A Wedzicha1*, Peter MA Calverley2, Terence A Seemungal3, Gerry Hagan4, Zainab Ansari4, and Robert A Stockley5

1 Academic Unit of Respiratory Medicine, Royal Free and University College Medical School, University College London, London, United Kingdom, 2 Department of Medicine, University Hospital Aintree, Liverpool, United Kingdom, 3 Department of Clinical Medical Scienes, The University of the West Indies, Mount Hope, Trinidad and Tobago, 4 Respiratory Medicines Centre, GSK, Greenford, Middlesex, United Kingdom, 5 Department of Medicine, University Hospital Birmingham NHS Foundation Trust, Birmingham, United Kingdom

* To whom correspondence should be addressed. E-mail: j.a.wedzicha{at}medsch.ucl.ac.uk.

Rationale: Exacerbations are key drivers of morbidity and mortality in chronic obstructive pulmonary disease (COPD). Objectives: We compared the relative efficacy of the long-acting inhaled bronchodilator/anti-inflammatory combination (salmeterol/fluticasone propionate) 50/500mcg bd and the long-acting bronchodilator (tiotropium) 18mcg od in preventing exacerbations and related outcomes in moderate-severe COPD. Methods: 1323 patients (mean age 64yr, forced expiratory volume in 1sec 39% predicted) were randomized in 2-year, double-blind, double-dummy, parallel study. Measurements and Main Results: Primary endpoint was healthcare utilization exacerbation rate. Other endpoints included health status measured by St. Georges Respiratory Questionnaire (SGRQ), mortality, adverse events and study withdrawal. Probability of withdrawing from the study was 29% greater with tiotropium than salmeterol/fluticasone propionate (p=0.005). The modelled annual exacerbation rate was 1.28 in the salmeterol/fluticasone propionate group and 1.32 in the tiotropium group (rate ratio 0.967 [95% CI: 0.836 to 1.119]; p=0.656). The SGRQ total score was statistically significantly lower at 2 years on salmeterol/fluticasone propionate versus tiotropium (difference 2.1 units, 95% CI: 0.1 to 4.0, p=0.038). Mortality was significantly lower in the salmeterol/fluticasone propionate group; 21 (3%) of patients in this group died compared to 38 (6%) in the tiotropium group (p=0.032). More pneumonias were reported in the salmeterol/fluticasone propionate group relative to tiotropium (p=0.008). Conclusions: We found no difference in exacerbation rate between salmeterol/fluticasone propionate and tiotropium. More patients failed to complete the study receiving tiotropium. A small statistically significant beneficial effect was found on health status, with an unexpected finding of lower deaths in salmeterol/fluticasone propionate treated patients. Clinical Trial Registry Information: ID# NCT00361959 registered at www.clinicaltrials.gov
Key words: COPD, exacerbations, mortality, health status




This article has been cited by other articles:


Home page
 JAMAHome page
S. Singh, Y. K. Loke, and C. D. Furberg
Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis
JAMA, September 24, 2008; 300(12): 1439 - 1450.
[Abstract] [Full Text] [PDF]

Home page
 ANN INTERN MEDHome page
T. A. Lee, A. S. Pickard, D. H. Au, B. Bartle, and K. B. Weiss
Risk for Death Associated with Medications for Recently Diagnosed Chronic Obstructive Pulmonary Disease
Ann Intern Med, September 16, 2008; 149(6): 380 - 390.
[Abstract] [Full Text] [PDF]

Home page
 Proc Am Thorac SocHome page
M. Moss, D. Wilkes, and L. B. Ware
Clinical Year in Review II: Pulmonary Infections in the Immunocompetent Host, Issues in the Training of Fellows and Residents, Asthma, and Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, September 15, 2008; 5(7): 745 - 750.
[Full Text] [PDF]

Home page
 Am. J. Respir. Crit. Care Med.Home page
S. F. Lanes and M. Jara
The INSPIRE Study: Influence of Prior Use and Discontinuation of Inhaled Corticosteroids
Am. J. Respir. Crit. Care Med., September 1, 2008; 178(5): 543 - 544.
[Full Text] [PDF]

Home page
 Am. J. Respir. Crit. Care Med.Home page
J. A. Wedzicha, P. M. A. Calverley, T. A. Seemungal, G. Hagan, Z. Ansari, R. A. Stockley, and On behalf of the INSPIRE Investigators
The INSPIRE Study: Influence of Prior Use and Discontinuation of Inhaled Corticosteroids
Am. J. Respir. Crit. Care Med., September 1, 2008; 178(5): 544 - 544.
[Full Text] [PDF]

Home page
 ChestHome page
M. B. Drummond, A. L. Blackford, J. O. Benditt, B. J. Make, F. C. Sciurba, M. C. McCormack, F. J. Martinez, H. E. Fessler, A. P. Fishman, R. A. Wise, et al.
Continuous Oxygen Use in Nonhypoxemic Emphysema Patients Identifies a High-Risk Subset of Patients: Retrospective Analysis of the National Emphysema Treatment Trial
Chest, September 1, 2008; 134(3): 497 - 506.
[Abstract] [Full Text] [PDF]

Home page
 Eur Respir JHome page
C. B. Cooper and M. Decramer
Inhaled steroids and COPD
Eur. Respir. J., August 1, 2008; 32(2): 523 - 524.
[Full Text] [PDF]

Home page
 Am. J. Respir. Crit. Care Med.Home page
A. Gillissen
Is Salmeterol/Fluticasone Propionate Equivalent to Tiotropium Bromide in the Treatment of COPD?
Am. J. Respir. Crit. Care Med., July 1, 2008; 178(1): 105 - 105.
[Full Text] [PDF]

Home page
 Am. J. Respir. Crit. Care Med.Home page
P. G. Middleton
Management of Patients with COPD: A Comparison of the INSPIRE and TORCH Studies
Am. J. Respir. Crit. Care Med., July 1, 2008; 178(1): 106 - 106.
[Full Text] [PDF]

Home page
 Am. J. Respir. Crit. Care Med.Home page
E. Marchand
Treatment Step Down Should Be Avoided at Entry in COPD Therapeutic Trials
Am. J. Respir. Crit. Care Med., July 1, 2008; 178(1): 105 - 106.
[Full Text] [PDF]

Home page
 Am. J. Respir. Crit. Care Med.Home page
J. A. Wedzicha, P. M. A. Calverley, T. A. Seemungal, G. Hagan, Z. Ansari, R. A. Stockley, and for the INSPIRE Investigators
Management of Patients with COPD: A Comparison of the INSPIRE and TORCH Studies
Am. J. Respir. Crit. Care Med., July 1, 2008; 178(1): 106 - 107.
[Full Text] [PDF]

Home page
 JWatch GeneralHome page
Tiotropium vs. Salmeterol/Fluticasone for COPD
Journal Watch (General), January 17, 2008; 2008(117): 2 - 2.
[Full Text]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH
Proc. Am. Thorac. Soc. Am. J. Respir. Cell Mol. Biol.
Copyright © 2007 American Thoracic Society