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Published ahead of print on October 19, 2006, doi:10.1164/rccm.200602-244OC

Am. J. Respir. Crit. Care Med., Volume 175, Number 2, January 2007, 144-149

A more recent version of this article appeared on January 15, 2007
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Submitted on February 19, 2006
Accepted on October 18, 2006

Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe COPD

Peter Kardos1*, Marion Wencker2, Thomas Glaab2, and Claus Vogelmeier3

1 Department of Respiratory Medicine, Maingau Hospital, Frankfurt am Main, Germany, 2 Department of Respiratory Medicine, TA Respiratory GlaxoSmithKline, Munich, Germany, 3 Department of Respiratory Medicine, Philipps University, Marburg, Germany

* To whom correspondence should be addressed. E-mail: pkardos{at}aol.com.

Rationale: Exacerbations of COPD greatly contribute to declining health status and the progression of the disease, thereby incurring significant direct and indirect healthcare 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 COPD patients with severe disease and a history of repeated exacerbations. Methods: Randomized, double-blind parallel-group study. After a 4 week 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 bd and 487 received salmeterol 50 µg bd for 44 weeks. 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 to that of the salmeterol group (128 d 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 to monotherapy with salmeterol significantly reduces the frequency of moderate/severe exacerbations in patients with severe COPD.
Key words: Inhaled corticosteroids, long acting beta 2 agonists, combination treatment, chronic obstructive pulmonary disease, exacerbation




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