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Published ahead of print on October 19, 2006, doi:10.1164/rccm.200602-244OC
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American Journal of Respiratory and Critical Care Medicine Vol 175. pp. 144-149, (2007)
© 2007 American Thoracic Society
doi: 10.1164/rccm.200602-244OC

Original Article

Impact of Salmeterol/Fluticasone Propionate versus Salmeterol on Exacerbations in Severe Chronic Obstructive Pulmonary Disease

Peter Kardos, Marion Wencker, Thomas Glaab and Claus Vogelmeier

Respiratory Medicine, Maingau Hospital, Frankfurt am Main; Therapeutic Area Respiratory, GlaxoSmithKline, Munich; and Department of Respiratory Medicine, Philipps University, Marburg, Germany

Correspondence and requests for reprints should be addressed to Peter Kardos, M.D., Group Practice and Center for Respiratory and Sleep Medicine, Allergy, Maingau Hospital, Scheffelstrasse 2, 60318 Frankfurt am Main, Germany. E-mail: pkardos{at}aol.com

Rationale: Exacerbations of chronic obstructive pulmonary disease (COPD) greatly contribute to declining health status and the progression of the disease, thereby incurring significant direct and indirect health care costs. The prevention of exacerbations, therefore, is an important treatment goal.

Objectives: To assess the impact of combination therapy with salmeterol/fluticasone propionate compared with salmeterol alone on moderate and severe exacerbations in patients with severe COPD and a history of repeated exacerbations.

Methods: Randomized, double-blind, parallel-group study. After a 4-wk run-in period, 994 clinically stable patients were randomized to one of two treatment groups: 507 patients received the salmeterol/fluticasone combination 50/500 µg twice daily and 487 received salmeterol 50 µg twice daily for 44 wk.

Main Results: The total number of exacerbations was 334 in the combination therapy and 464 in the salmeterol group (p < 0.0001). The annualized rate of moderate and severe exacerbations per patient was 0.92 in the combination therapy and 1.4 in the salmeterol group, corresponding to a 35% decrease. In addition, the mean time to first exacerbation in the combination therapy group was significantly longer compared with that of the salmeterol group (128 vs. 93 d, p < 0.0001). Other endpoints, including health-related quality of life, peak expiratory flow, and use of rescue medication, were significantly improved in the combination therapy group. Both treatments were well tolerated.

Conclusions: This study demonstrates that combination therapy with salmeterol/fluticasone compared with salmeterol monotherapy significantly reduces the frequency of moderate/severe exacerbations in patients with severe COPD.

Key Words: inhaled corticosteroids • long-acting beta2-agonists • combination treatment • chronic obstructive pulmonary disease • exacerbation


AT A GLANCE COMMENTARY

Scientific Knowledge on the Subject
Little evidence is available on the additional effect of inhaled corticosteroids in reducing exacerbations if prescribed in patients with severe COPD receiving long-acting bronchodilators.

What This Study Adds to the Field
This study shows a statistically significant, and clinically relevant, 35% reduction in COPD exacerbations as an effect of addition of inhaled corticosteroid to long-acting bronchodilator therapy.

 



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