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Effect of Pharmacotherapy on Rate of Decline of Lung Function in COPD: Results from the TORCH Study.
Celli, B, Thomas, N, Anderson, J, Ferguson, G, Jenkins, C, Jones, P, Vestbo, J, Knobil, K, Yates, J, Calverley, P
Am J Respir Crit Care Med. 2008;.
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Abstract
RATIONALE: Chronic obstructive pulmonary disease (COPD) is characterized by an accelerated decline in lung function. No drug has been shown conclusively to reduce this decline. OBJECTIVE: In a post-hoc analysis of the towards a Revolution in COPD Health (TORCH) study we investigated the effects of combined salmeterol 50microg plus fluticasone propionate 500microg, either component alone or placebo, on the rate of post-bronchodilator forced expiratory volume in one second (FEV1) decline in patients with moderate-to-severe COPD. METHODS: Randomized, double-blind, placebo-controlled study conducted from September 2000 to November 2005 in 42 countries. Of 6112 patients from the efficacy population, 5343 were included in this analysis. MEASUREMENTS AND MAIN RESULTS: Spirometry was measured every 24 weeks for 3 years. There were 26,539 on-treatment observations. The adjusted rate of decline in FEV1 was 55mL/year for placebo, 42mL for salmeterol, 42mL for fluticasone propionate and 39mL/year for salmeterol plus fluticasone propionate. Salmeterol plus fluticasone propionate reduced the rate of FEV1 decline by 16mL/year compared with placebo (95% CI, 7 to 25; P<0.001). The difference was smaller for fluticasone propionate and salmeterol compared with placebo (13mL/year, 95% CI,5 to 22; P=0.003). Rates of decline were similar among the active treatment arms. FEV1 declined faster in current smokers and patients with a lower body mass index, and varied between world regions. Patients who exacerbated more frequently had a faster FEV1 decline. CONCLUSIONS: Pharmacotherapy with salmeterol plus fluticasone propionate, or the components, reduces the rate of decline of FEV1 in patients with moderate-to severe COPD, thus slowing disease progression. Clinical trials information available at www.clinicaltrials.gov, i.d.# NCT00268216.