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Fluticasone and salmeterol reduce mortality in COPD

Q What is the best inhaled treatment for chronic obstructive pulmonary disease: a steroid, a ß-agonist, or both? Synopsis

In this study, patients were between the ages of 40 and 80 with COPD, defined as a forced expiratory volume in one second [FEV1] of less than 60%, an increase in FEV1 of less than 10% with bronchodilators, and an FEV1/forced vital capacity ratio of =0.7.

The average age of the 6,112 participants was 65; 75% were men, and 43% were current smokers. Groups were balanced at the start of the study. They were randomised (allocation concealed) to receive either salmeterol (50µg), fluticasone (500µg), both, or placebo inhaled twice daily. Analysis was by intention to treat and patients were followed up for three years. The primary outcome of death by any cause was adjudicated by researchers unaware of treatment assignment. After three years, 16% in the fluticasone group, 15.2% in the placebo group, 13.5% in the salmeterol group and 12.6% in the salmeterol plus fluticasone group had died. There was a trend toward reduced mortality with the combination compared with placebo (hazard ratio [HR] = 0.825; 95% CI, 0.68-1.002) but no difference between each agent individually and placebo. Patients receiving the combination had a lower mortality rate than those taking fluticasone alone (HR = 0.77; 0.64-0.93). Exacerbations of COPD were less frequent with the combination therapy than with placebo (0.85 versus 1.13/year; P<0.001). however,="" the="" risk="" of="" pneumonia="" was="" higher="" in="" the="" combination="" therapy="" group="" (19.6%="" versus="" 12.3%;="" number="" needed="" to="" treat="" to="" harm="" [nnh]="14;">

Level of evidence

1b (see www.infopoems.com/concept/ebm _loe.cfm)

Reference

Calverley PM et al, for the TORCH investigators. Salmeterol and fluticasone and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356:775-89.

Bottom line

The combination of inhaled salmeterol and fluticasone slightly reduces the risk of exacerbation compared with placebo alone, about one fewer for every three years of treatment. There was a trend toward a reduction in mortality, but it was not statistically significant (12.6% versus 16.0%, p = 0.052). Combination therapy increases the risk of pneumonia (NNH = 14).

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