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The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide.
Am J Respir Crit Care Med. 2008 Jan 01; 177(1):19-26.AJ

Abstract

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/antiinflammatory combination (salmeterol/fluticasone propionate) 50/500 microg twice daily and the long-acting bronchodilator (tiotropium) 18 microg once daily in preventing exacerbations and related outcomes in severe and very severe COPD.

METHODS

A total of 1,323 patients (mean age, 64 yr, post-bronchodilator FEV1, 39% predicted) were randomized in this 2-year, double-blind, double-dummy parallel study.

MEASUREMENTS AND MAIN RESULTS

Primary endpoint was health care utilization exacerbation rate. Other endpoints included health status measured by St. George's 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 modeled annual exacerbation rate was 1.28 in the salmeterol/fluticasone propionate group and 1.32 in the tiotropium group (rate ratio, 0.967; 95% confidence interval [CI], 0.836-1.119]; 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, 0.1-4.0; P = 0.038). Mortality was significantly lower in the salmeterol/fluticasone propionate group; 21 (3%) of patients in this group died compared with 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 while 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 registered with www.clinicaltrials.gov (NCT 00361959).

Authors+Show Affiliations

Academic Unit of Respiratory Medicine, Royal Free & University College Medical School, University College London, London, UK. j.a.wedzicha@medsch.ucl.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17916806

Citation

Wedzicha, Jadwiga A., et al. "The Prevention of Chronic Obstructive Pulmonary Disease Exacerbations By Salmeterol/fluticasone Propionate or Tiotropium Bromide." American Journal of Respiratory and Critical Care Medicine, vol. 177, no. 1, 2008, pp. 19-26.
Wedzicha JA, Calverley PM, Seemungal TA, et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med. 2008;177(1):19-26.
Wedzicha, J. A., Calverley, P. M., Seemungal, T. A., Hagan, G., Ansari, Z., & Stockley, R. A. (2008). The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. American Journal of Respiratory and Critical Care Medicine, 177(1), 19-26.
Wedzicha JA, et al. The Prevention of Chronic Obstructive Pulmonary Disease Exacerbations By Salmeterol/fluticasone Propionate or Tiotropium Bromide. Am J Respir Crit Care Med. 2008 Jan 1;177(1):19-26. PubMed PMID: 17916806.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. AU - Wedzicha,Jadwiga A, AU - Calverley,Peter M A, AU - Seemungal,Terence A, AU - Hagan,Gerry, AU - Ansari,Zainab, AU - Stockley,Robert A, AU - ,, Y1 - 2007/10/04/ PY - 2007/10/6/pubmed PY - 2008/1/8/medline PY - 2007/10/6/entrez SP - 19 EP - 26 JF - American journal of respiratory and critical care medicine JO - Am J Respir Crit Care Med VL - 177 IS - 1 N2 - 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/antiinflammatory combination (salmeterol/fluticasone propionate) 50/500 microg twice daily and the long-acting bronchodilator (tiotropium) 18 microg once daily in preventing exacerbations and related outcomes in severe and very severe COPD. METHODS: A total of 1,323 patients (mean age, 64 yr, post-bronchodilator FEV1, 39% predicted) were randomized in this 2-year, double-blind, double-dummy parallel study. MEASUREMENTS AND MAIN RESULTS: Primary endpoint was health care utilization exacerbation rate. Other endpoints included health status measured by St. George's 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 modeled annual exacerbation rate was 1.28 in the salmeterol/fluticasone propionate group and 1.32 in the tiotropium group (rate ratio, 0.967; 95% confidence interval [CI], 0.836-1.119]; 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, 0.1-4.0; P = 0.038). Mortality was significantly lower in the salmeterol/fluticasone propionate group; 21 (3%) of patients in this group died compared with 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 while 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 registered with www.clinicaltrials.gov (NCT 00361959). SN - 1535-4970 UR - https://www.unboundmedicine.com/medline/citation/17916806/The_prevention_of_chronic_obstructive_pulmonary_disease_exacerbations_by_salmeterol/fluticasone_propionate_or_tiotropium_bromide_ L2 - https://www.atsjournals.org/doi/10.1164/rccm.200707-973OC?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -