Results of the TOwards a Revolution in COPD Health (TORCH) study, the largest of its kind have been published today in the New England Journal of Medicine1 and represent a landmark in COPD, a disease which kills more people each year than breast cancer and lung cancer combined.2,3 The results show important benefits of Seretide in the treatment of patients with COPD.
The three year study was designed to investigate reductions in death from any cause as the primary endpoint and also measured improvements in exacerbations (or worsening of symptoms) and quality of life as key secondary findings. The results from TORCH have been submitted to the regulatory authorities for consideration for inclusion into Seretide prescribing information. The full data set of the TORCH study was undertaken in COPD patients with an FEV1
Commenting on the results, lead investigator Professor Peter Calverley said: "We are very proud of undertaking such an ambitious study. This is the first time a study has been carried out to investigate whether a medicine can have an impact on both survival and improvements in quality of life in patients with COPD. The steering committee for TORCH believes that these results are clinically important and have progressed our understanding of this disabling and potentially fatal disease, so that we can make informed choices in the treatment and management of our patients."
There was an increased risk of pneumonia seen as adverse events or serious adverse events in the inhaled corticosteroid containing arms of the TORCH study. The number of deaths while on treatment which were attributable to pneumonias, as adjudicated by the Clinical Endpoints Committee, was 7 in the control group, 9 in the salmeterol group, 13 in the fluticasone propionate group, and 8 in the Seretide group. Treatment with Seretide did not appear to be associated with an increased risk of COPD patients dying from pneumonia. There were no increases in bone or eye disorders in patients treated with Seretide compared with the control group.1
Current guidelines state that in addition to relieving symptoms, preventing exacerbations and improving health-related quality of life, reducing mortality is a goal of COPD treatment.9 TORCH is the first study to investigate whether medication can affect survival in patients with COPD; to date smoking cessation, home oxygen treatment and lung volume reduction surgery are the only therapies shown to improve survival in patients with COPD.1
Darrell Baker, head of the Respiratory Medicines Development Centre for GSK, said: "We are delighted with the results of this landmark study. The results have been submitted to regulatory authorities world-wide for consideration for inclusion into Seretide prescribing information."
The TORCH study was sponsored by GlaxoSmithKline.
About COPD
Chronic Obstructive Pulmonary Disease (COPD) is a debilitating and potentially fatal disease, but it can be both prevented and treated. The disease has a number of different components causing limitations to airflow in the lungs and breathing difficulties. These include increased inflammation in the airways, direct damage and structural changes to the lungs and reduced body mass, weakness and wasting, which affect the health status of the person and ultimately their survival. Improving survival remains a major unmet need for patients with COPD1.
More than three million people in the UK are thought to be affected by COPD10. Unfortunately, the disease takes around 22,000 lives in the UK each year11. By 2020 COPD is projected to be the third leading cause of death and fifth leading cause of disability worldwide following only ischaemic heart disease, depression, traffic accidents and cerebrovascular disease12.
About TORCH
TORCH (TOwards a Revolution in COPD Health) is the first and largest study to prospectively investigate the potential for Seretide (salmeterol/fluticasone propionate) 50/500 ?µg to impact survival in patients with Chronic Obstructive Pulmonary Disease (COPD). TORCH is a three year, multicentre, randomised, double-blind, parallel group, placebo-controlled study. Approximately 6,100 patients meeting the European Respiratory Society definitions for COPD were randomised from 439 sites in 42 countries to one of the following 4 treatment groups:1
-- Placebo
-- Salmeterol (50 ?µg)
-- Fluticasone propionate (500 ?µg)
-- Seretide (50/500 ?µg), all inhaled twice daily via the 500 Accuhaler™
In all treatment arms patients were allowed to take other medications to treat COPD symptoms including anticholinergics, theophylline and salbutamol (similar usage was seen across treatment arms). Patients were instructed not to take inhaled corticosteroids, long term oral corticosteroids or long-acting bronchodilators while enrolled in the study.
The primary end point of TORCH was the reduction in all-cause mortality, comparing Seretide with placebo. Secondary endpoints include:1
-- COPD morbidity (as measured by the rate of exacerbations [moderate requiring systemic corticosteroids and/or antibiotics or severe requiring hospitalisation])
-- Quality of life (as measured by St George's Respiratory Questionnaire (SGRQ))
In the TORCH trial, the reduction in all-cause mortality between Seretide and the control groups did not meet the pre-specified significance level. In the NEJM paper, the authors suggest that the lower than anticipated number of deaths and the high withdrawal rate in patients receiving placebo, who were free to receive active therapy subsequently, including Seretide, may have contributed to the final results not reaching statistical significance.1
About Seretide
Seretide is a combined treatment of fluticasone propionate, an inhaled corticosteroid and salmeterol, a long acting bronchodilator. Each component targets different aspects of the pathophysiology of COPD a multi-component disease with inflammation at the core.
The inflammation seen in patients with COPD is present even in the early stages of the disease and is associated with disease progression.13 Seretide has been shown to have a broad range of anti-inflammatory effects in COPD which are greater than those seen with inhaled corticosteroids (ICS) in single treatment.14,15
About GSK
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit gsk.
References
1. Peter M.A. Calverley M.D. et al on behalf of the TORCH investigators. Salmeterol and fluticasone propionate and survival in Chronic Obstructive Pulmonary Disease. NEJM 2007; 356: 775-789
2. WHO. The World Health Report 2002. Reducing risks, promoting healthy life
3. Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004
4. Seemungal TAR, Donaldson GC, Bhowmik A, Jeffries DJ, Wedzicha JA. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2000; 161: 1608-1613
5. Thompson WL. Pulmonary Disease. In: Stoudemire A, Fogel BS, Greeberg DB, eds. Psychiatric care of the medical patient. 2nd ed. New York, NY: Oxford University Press; 2000:757-774.
6. Kunik ME, Roundy K, Veazey C, Souchek J, Richardson P, Wray NP, Stanley MA. Surprisingly High Prevalence of Anxiety and Depression in Chronic Breathing Disorders. Chest 2005; 127;1205-1211
7. European Federation of Allergy and Airway Diseases Patients Association. European COPD Patient Manifesto. efanet. (Last accessed 17 January 2007).
8. Vermeire P. The burden of chronic obstructive pulmonary disease. Respir Med 2002: 96(Suppl C): S3-S10.
9. Global Initiative for Chronic Obstructive Lung Disease 2006. Global strategy for the diagnosis, management, and prevention of COPD. Available from goldcopd (last accessed 12th January 2007)
10. British Lung Foundation. 'Missing Millions' Campaign, World COPD Day 2006
11. Data obtained and extrapolated from Office for National Statistics on mortality 2004
12. European Respiratory Society, European Lung Federation, European Lung White Book, 2003.
13. Hogg JC, Chu F. The Nature of Small-Airway Obstruction in Chronic Obstructive Pulmonary Disease. NEMJ 2004; 350;26
14. Yamauchi Y, Christodoulopoulos P, Olivenstein R, Maltais F, Bourbeau J, Hamid Q. The Effect of Salmeterol/Fluticasone Combination on Airway Inflammation in COPD Compared to Fluticasone. PATS 2006; 3(abstracts issue): A113
15. Barnes N, Qiu Y, Pavord I et al. Antiinflammatory Effects of Salmeterol/Fluticasone Proprionate in Chronic Obstructive Lung Disease. Am J Respir Crit Care Med 2006; 173: 736-743
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