Significant Reduction In Rate Of Lung Function Decline Achieved In COPD Patients Receiving Seretide®/Advair®

Main Category: Respiratory / Asthma
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 16 Aug 2008 - 1:00 PDT

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Study results published show that treatment with Seretide®/Advair® (salmeterol/fluticasone propionate 50/500mcg) can slow the progression of Chronic Obstructive Pulmonary Disease (COPD) by significantly lowering a patient's rate of lung function decline compared with those receiving placebo. [1] This is the first time a treatment has been shown to slow the decline in lung function and impact progression of this serious lung disease, which accounts for more than 3 million deaths worldwide each year.[2]

The results showed that treatment can decrease the excess decline in lung function (measured by forced expiratory volume in 1 second [FEV1]) seen in patients with COPD by more than 50%, representing a significant slowing of disease progression. Those patients who received salmeterol/fluticasone propionate had a lower rate of decline in lung function compared to those who received placebo (39mL vs 55mL per year [p <0.001]).* The findings, published in the American Journal of Respiratory and Critical Care Medicine, are from a post-hoc analysis of the TOwards a Revolution in COPD Health (TORCH) study of more than 6,000 patients with COPD.

Data from this analysis also showed that salmeterol and fluticasone propionate given individually also significantly reduced the rate of lung function decline, although to a lesser degree than the combination (42mL vs 55 mL per year with placebo; p =0.003).1

Commenting on the results, Professor Bartolome Celli, Pulmonary and Critical Care division, Caritas-St Elizabeth's Medical Centre, Boston, Massachusetts, USA, member of the TORCH study steering committee and lead author said, "These findings further expand the proven benefit that patients living with COPD can get from treatment with the combination of salmeterol/fluticasone propionate. COPD has a poor prognosis, so actually having a treatment that can slow the progression of the disease for patients is a significant development."

"As leaders in the respiratory field, GSK is excited about these findings. It is good news for patients that treatment with Seretide/Advair has for the first time been shown to help slow the progression of their disease, in addition to improving their lung function and reducing exacerbations," commented Darrell Baker, Senior Vice President, Respiratory Medicines Development Centre, GSK. He continued, "Long-term studies, such as TORCH, offer physicians and researchers valuable insights into the management and mechanisms of COPD. Moving forward, GSK remains committed to conducting research to expand further our understanding of the management of COPD."

FEV1 is accepted to be an important indicator of COPD progression and the most accurate clinical measure of lung function. To-date smoking cessation has been the only intervention that has been conclusively shown to alter the rate of decline in FEV1.

The original findings from TORCH demonstrated that treatment with salmeterol/fluticasone propionate resulted in a trend towards a reduction in all-cause mortality, although the mortality benefit did not reach statistical significance. In addition, the study confirmed that treatment with salmeterol/fluticasone propionate provides improvements in lung function over three years and reduces the rate of exacerbations, even when there is no previous exacerbation history in COPD patients. [3] TORCH continues to generate important findings and data regarding the effective management of COPD.

About Seretide (Europe only)

Seretide was approved in the European Union in 2003 for the symptomatic treatment of severe COPD; i.e. for patients with a FEV1 <50% of predicted normal, a history of repeated exacerbations and significant symptoms despite regular bronchodilator therapy. In light of the results of the TORCH study, this licence has been extended to COPD patients with moderate disease: FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. [4]

About Advair in COPD (US only)

Advair Diskus 250/50 is indicated for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Advair Diskus 250/50 is also indicated to reduce exacerbations in patients with a history of exacerbations. Advair Diskus 250/50 is the only approved strength for COPD in the U.S., because an efficacy advantage of the higher strength Advair Diskus 500/50 over Advair Diskus 250/50 has not been demonstrated.

About Seretide in COPD (Korea only)

Seretide Diskus 250/50 is indicated for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema in Korea. Seretide Diskus 250/50 is the only approved strength for COPD in the Korea.

About COPD

COPD is a preventable and treatable disease state usually caused by smoking, it is characterised by airflow limitation that is not fully reversible. [5] Itis a global killer, being responsible for the deaths of over 3 million people a year2 - more than lung cancer and breast cancer combined. [6],[7] It is now becoming clear that inflammation is at the core of the disease, [8] driving disease progression and being present at all stages, [9] but COPD is also a multi-component disease involving airway structural changes, mucociliary dysfunction and airway inflammation, all leading to airflow limitation, together with an important systemic component. [10],[11],[12] Clinically, the components of COPD contribute to progressive changes in lung function, symptoms and exacerbations (defined as a deterioration in symptoms), which affect patients' health status and ultimately survival. [13]

About TORCH

The TORCH study was the first, multicentre, randomised, double-blind, parallel-group, placebo-controlled study to prospectively compare the effects of salmeterol alone, fluticasone propionate alone, a fixed-dose combination of salmeterol and fluticasone propionate, and placebo on mortality in patients with moderate to severe copd. Primary publication of results from the TORCH study were published in the New England Journal of Medicine in February 2007 and represented a landmark, as the study provided important clarification concerning the role of pharmacotherapy in the clinical management of COPD.3

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 further information please visit http://www.gsk.com

References

The rate of decline in lung function in healthy patients has been estimated at ~30mL/year (James AL, Palmer LJ, Kicic E, et al. 2005. Lange P, Parner J, Vestbo J. 1998)). Treatment with salmeterol/fluticasone propionate reduced the difference between the decline seen in COPD patients compared to those on placebo by more than half

[1] Celli BR, et al. Effect of Pharmacotherapy on Rate of Decline of Lung Function in COPD: Results from the TORCH Study. Am. J. Respir. Crit. Care Med. 2008:200712-1869OC.

[2] WHO. Chronic Obstructive Pulmonary Disease (COPD): Fact Sheet No. 315. In: WHO, editor. COPD, 2008.

[3] Calverley PMA, et al. Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease. N Engl J Med 2007;356(8):775-789.

[4] Final Variation Assessment Report Seretide Diskus/Viani Diskus Seretide Evohaler/Viani Evohaler (fluticasone proprionate/salmeterol xinafoate).

[5] Celli BR, et al. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J 2004;23(6):932-946.

[6] WHO. The World Health Report 2002. Reducing risks, promoting healthy life. Geneva: World Health Organization, 2002.

[7] Ferlay J. Cancer Incidence, mortality and prevalence worldwide. IARC CancerBase No.5. Lyon: IARC Press, 2004.

[8] Halpin DM, Miravitlles M. Chronic obstructive pulmonary disease: the disease and its burden to society. Proc Am Thorac Soc 2006;3(7):619-23.

[9] Hogg JC, et al. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med 2004;350(26):2645-53.

[10] Agusti AG, et al. Systemic effects of chronic obstructive pulmonary disease. Eur Respir J 2003;21(2):347-60.

[11] Agusti AG. COPD, a multicomponent disease: implications for management. Respir Med 2005;99(6):670-82

[12] Wouters EF, et al. Systemic effects in COPD. Chest 2002;121(5 Suppl):127S-130S.

[13] Global Strategy for the diagnosis, Management and prevention of COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2007.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.