�Study results published show that treatment with Seretide�/Advair� (salmeterol/fluticasone propionate 50/500mcg) lavatory 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 procedure and impact progression of this good lung disease, which accounts for more than than 3 million deaths worldwide each year.[2]
The results showed that treatment privy decrease the excess decline in lung function (deliberate by forced expiratory volume in 1 second [FEV1]) seen in patients with COPD by more than 50%, representing a pregnant slowing of disease progression. Those patients who received salmeterol/fluticasone propionate had a lower rate of pass up in lung function compared to those who received placebo (39mL vs 55mL per year [p
Data from this analysis also showed that salmeterol and fluticasone propionate given individually also significantly rock-bottom the pace of lung function decline, although to a lesser degree than the combination (42mL vs 55 mL per class 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, extremity of the TORCH study steering citizens committee and lead author aforementioned, "These findings further boom the proved benefit that patients surviving with COPD can get from discourse with the combination of salmeterol/fluticasone propionate. COPD has a inadequate 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 beneficial 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 attached to conducting research to expand farther our savvy of the management of COPD."
FEV1 is accepted to be an important indicator of COPD progression and the almost accurate clinical measure of lung function. To-date smoking cessation has been the only intervention that has been once and for all 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 deathrate, although the mortality benefit did not reach statistical significance. In addition, the study confirmed that handling with salmeterol/fluticasone propionate provides improvements in lung function over trey 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 efficient management of COPD.
About Seretide (Europe only)
Seretide was sanctioned in the European Union in 2003 for the symptomatic treatment of severe COPD; i.e. for patients with a FEV1
About Advair in COPD (US only)
Advair Diskus 250/50 is indicated for the maintenance treatment of air flow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Advair Diskus 250/50 is also indicated to shorten exacerbations in patients with a history of exacerbations. Advair Diskus 250/50 is the exclusively 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 blockage in patients with COPD, including chronic bronchitis and/or emphysema in Korea. Seretide Diskus 250/50 is the only sanctioned strength for COPD in the Korea.
About COPD
COPD is a preventable and treatable disease state commonly caused by smoking, it is characterised by airflow limitation that is not fully reversible. [5] Itis a worldwide killer, beingness responsible for the deaths of over 3 trillion people a year2 - more than lung crab and breast cancer combined. [6],[7] It is now becoming clear that inflammation is at the core of the disease, [8] driving disease progress and existence present at all stages, [9] simply COPD is also a multi-component disease involving airline structural changes, mucociliary dysfunction and respiratory tract inflammation, all leading to airflow limit, 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-class honours degree, multicentre, randomised, double-blind, parallel-group, placebo-controlled sketch 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 elucidation concerning the role of pharmacotherapy in the clinical management of COPD.3
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References
The rate of decline in lung mapping 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 handling of patients with COPD: a compendious of the ATS/ERS military 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 world. IARC CancerBase No.5. Lyon: IARC Press, 2004.
[8] Halpin DM, Miravitlles M. Chronic obstructive pulmonary disease: the disease and its burden to society. RPLC227% 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 continuing 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 advanced statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that whatsoever forward-looking statements or projections made by GSK, including those made in this announcement, ar subject to risks and uncertainties that may case actual results to differ materially from those jutting. Factors that may move GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.
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