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Effect of Pharmacotherapy on Rate of Decline of Lung Function in Chronic Obstructive Pulmonary Disease

Results from the TORCH Study

¹ Tufts University School of Medicine, Pulmonary and Critical Care Division, Caritas-St. Elizabeth's Medical Center, Boston, Massachusetts; ² Respiratory Medicines Centre, GlaxoSmithKline, Greenford, Middlesex, United Kingdom; ³ Pulmonary Research, Institute of Southeast Michigan, Livonia, Michigan; ⁴ Woolcock Institute of Medical Research, Camperdown, New South Wales, Australia; ⁵ Division of Cardiac and Vascular Science, St George's University of London, London, United Kingdom; ⁶ Cardiology and Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark; ⁷ North West Lung Centre, Wythenshawe Hospital, Manchester, United Kingdom; ⁸ Respiratory Medicines Centre, GlaxoSmithKline, Research Triangle Park, North Carolina; and ⁹ Department of Medicine, University Hospital Aintree, Liverpool, United Kingdom

Correspondence and requests for reprints should be addressed to Bartolomé Celli, M.D., Professor of Medicine, Tufts University School of Medicine, Pulmonary and Critical Care Division, Caritas-St. Elizabeth's Medical Center, Boston, MA, 02135-2997. E-mail: bcelli{at}copdnet.org

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.

Objectives: In a post hoc analysis of the Toward a Revolution in COPD Health (TORCH) study, we investigated the effects of combined salmeterol 50 µg plus fluticasone propionate 500 µg, either component alone or placebo, on the rate of post-bronchodilator FEV₁ decline in patients with moderate or severe COPD.

Methods: A randomized, double-blind, placebo-controlled study was conducted from September 2000 to November 2005 in 42 countries. Of 6,112 patients from the efficacy population, 5,343 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 55 ml/year for placebo, 42 ml/year for salmeterol, 42 ml/year for fluticasone propionate, and 39 ml/year for salmeterol plus fluticasone propionate. Salmeterol plus fluticasone propionate reduced the rate of FEV₁ decline by 16 ml/year compared with placebo (95% confidence interval [CI], 7–25; P < 0.001). The difference was smaller for fluticasone propionate and salmeterol compared with placebo (13 ml/year; 95% CI, 5–22; 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 trial (GSK Study Code SCO30003) registered with www.clinicaltrials.gov (NCT00268216).

Key Words: FEV₁ • salmeterol • fluticasone propionate • disease progression

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject The decline in FEV1 has been accepted as a key marker for progression of chronic obstructive pulmonary disease (COPD). To date, smoking cessation is the only intervention that has conclusively been shown to alter the rate of decline in FEV1. What This Study Adds to the Field This study shows that pharmacotherapy with combined salmeterol 50 µg plus fluticasone propionate 500 µg, or either component alone, can reduce the rate of decline of FEV1 in patients with moderate-to-severe COPD, thus slowing disease progression.

 

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