Salmeterol/fluticasone combination in the treatment of COPD

Abstract

Clinical trials of a combination therapy of an inhaled corticosteroid, fluticasone propionate (FP), with a long-acting beta2-agonist, salmeterol (Sal), have demonstrated a greater improvement in lung function and in quality of life measures after the combination compared with either component of alone. In a subanalysis of the data of the TRISTAN study, Sal/FP reduced exacerbation rates in COPD patients with a baseline FEV1 < 50% of predicted. A combination therapy of budesonide and formoterol improved quality of life and FEV1, and reduced exacerbations better than either component alone. In studies of FP or of Sal/FP in COPD, there was a reduction in all-cause mortality by 25% relative to placebo. Sal/FP has anti-inflammatory effects in COPD airways. FP inhibits markers of systemic inflammation, and it is not known whether Sal/FP has an advantage over FP alone. While long-acting beta2-agonists such as Sal can be recommended for treatment of moderate COPD, addition of inhaled steroid therapy such as FP should be considered in more severe disease.

Figure 1

Mean changes from baseline of prebronchodilator FEV₁ (A), postbronchodilator FEV₁ (B), daily peak expiratoiry flows (C), and St Georges’ health status scores (D) in the TRISTAN study. Reprinted from Calverley P, Pauwels R, Vestbo J, et al. 2003a. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet, 361:449–56. Coypright © 2003 with permission from Elsevier.

Figure 2

Cumulative risk of acute exacerbations in the TRISTAN study. There were no differences between the three active treatment groups. Reprinted from Calverley P, Pauwels R, Vestbo J, et al. 2003a. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet, 361:449–56. Coypright © 2003 with permission from Elsevier.