Effect of fluticasone propionate/salmeterol (250/50 μg) or salmeterol (50 μg) on COPD exacerbations

Gary T. Ferguson, Antonio Anzueto, Richard Fei, Amanda Emmett, Katharine Knobil, Christopher Kalberg

Research output: Contribution to journalArticlepeer-review

183 Scopus citations

Abstract

Objectives: COPD exacerbations are associated with significant morbidity and mortality. This randomized, double-blind, parallel-group, multicenter study evaluated the effect of fluticasone propionate/salmeterol 250/50 and salmeterol 50 μg twice daily on moderate to severe exacerbations. Methods: Patients received standardized treatment with fluticasone propionate/salmeterol 250/50 during a 1-month run-in, followed by randomization to fluticasone propionate/salmeterol 250/50 or salmeterol for 12 months. Moderate to severe exacerbations were defined as worsening symptoms of COPD requiring treatment with oral corticosteroids, antibiotics, or hospitalization. Results: In 782 patients with COPD (mean FEV1 = 0.94 ± 0.36 L, 33% predicted normal), treatment with fluticasone propionate/salmeterol 250/50 significantly reduced (1) the annual rate of moderate to severe exacerbations by 30.5% compared with salmeterol (1.06 and 1.53 per subject per year, respectively, p < 0.001), (2) the risk of time to first exacerbation by 25% (hazard ratio = 0.750, p = 0.003) and (3) the annual rate of exacerbations requiring oral corticosteroids by 40% (p < 0.001). Clinical improvements observed during run-in treatment with fluticasone propionate/salmeterol 250/50 were better maintained over 12 months with fluticasone propionate/salmeterol 250/50 than salmeterol. Adverse events were reported for a similar percentage of subjects across groups. A higher reporting of pneumonia was observed with fluticasone propionate/salmeterol 250/50 than salmeterol (7% vs. 4%). Conclusions: We conclude that fluticasone propionate/salmeterol 250/50 is more effective than salmeterol at reducing the rate of moderate to severe exacerbations over 1 year. The benefits of this reduction relative to the risk of a higher incidence of reported pneumonia should be considered. This study supports the use of fluticasone propionate/salmeterol 250/50 for the reduction of COPD exacerbations in patients with COPD.

Original languageEnglish (US)
Pages (from-to)1099-1108
Number of pages10
JournalRespiratory Medicine
Volume102
Issue number8
DOIs
StatePublished - Aug 2008

Keywords

  • Chronic obstructive pulmonary disease (COPD)
  • Exacerbations
  • Fluticasone propionate
  • Inhaled corticosteroid
  • Long-acting beta-agonist
  • Salmeterol

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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