Patients with severe COPD may benefit from the addition of an inhaled corticosteroid

In a randomized, double-blind, parallel-group trial published in the American Journal of Respiratory and Critical Care Medicine, the combination of fluticasone and salmeterol (SAL) statistically significantly reduced the number of chronic obstructive pulmonary disease (COPD) exacerbations by 35% compared with SAL alone.

The authors said very few studies have been done to determine whether adding inhaled corticosteroids to therapy with long-acting bronchodilators can help reduce exacerbations in patients with severe COPD. This study was designed to assess such benefit, if any, and did not include a placebo and fluticasone propionate (FP) monotherapy arm. The 994 patients who participated in the study had severe COPD (Stage III or IV), as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, were aged ≥40 years, had a ≥10 pack-year smoking history, and had a documented history of ≥2 moderate-to-severe exacerbations in the year before the study. The patients were randomized to receive either SAL plus fluticasone (SFC) 50/500 mcg twice daily or monotherapy with SAL 50 mcg twice daily for a total of 44 weeks. The primary study end point was the number of moderate and severe COPD exacerbations in each group.

When compared with patients who received SAL alone (n=487), those who received SFC (n=507) experienced fewer annual exacerbations (1.4 vs 0.92, respectively; treatment effect ratio=0.65; 95% CI, 0.57–0.76; P<.0001). The mean time to first exacerbation in SFC-treated patients was significantly longer compared with that of the SAL-treated patients (128 vs 93 days, respectively; P<.0001).

COPD is the fourth-leading cause of chronic morbidity and mortality in the United States. In 2002, the direct costs of treating COPD were approximately $18 billion, and the indirect costs (lost productivity due to disease) totaled $14.1 billion.

The authors stressed the importance of adding an inhaled corticosteroid to therapy with a long-acting bronchodilator, and they compared the number needed-to-treat with SFC versus SAL to prevent 1 moderate or severe exacerbation per year (2.08) with the numbers needed-to-treat for 5 years with antihypertensive drugs to prevent 1 cardiovascular event (18) and for 6 years to prevent one myocardial infarction with pravastatin (52)

Current COPD treatment guidelines recommend adding an inhaled corticosteroid to bronchodilator treatment in symptomatic COPD patients with severe or very severe COPD (Stage III or IV) and repeated exacerbations (>3 exacerbations over a 3-year period). The use of long-term treatment with systemic oral corticosteroids is not recommended.

SOURCES

Kardos P, Wencker M, Glaab T, Vogelmeier C. Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007;175:144–149.

Global initiative for chronic obstructive lung disease (GOLD). Executive summary: Global strategy for the diagnosis, management, and prevention of COPD. Available at: http:// http://www.goldcopd.org/guidelineitem.asp?l1=2&l2=1&intid=996. Accessed February 23, 2007.