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Advair Diskus (Salmeterol /Fluticasone Propionate) Approved for Chronic Obstructive Pulmonary Disease

MISSISSAUGA, ON -- May 12, 2003 -- Canadians whose daily activities are impaired by chronic obstructive pulmonary disease (COPD) have a new treatment option to help provide greater symptom relief and improve their quality of life which may result in reduced hospital visits.

Advair 250 and 500 Diskus (salmeterol/fluticasone propionate), developed by GlaxoSmithKline Inc. and approved by Health Canada, helps reduce attacks of extreme breathlessness and improves lung function.

A recent study published in The Lancet(1) found that patients taking Advair experienced a 25 to 39 per cent reduction in these attacks of breathlessness, the most important trigger for hospital admissions. It is estimated that one out of every ten COPD patients admitted to hospital due to severe attacks of breathlessness will die in hospital.(2) Clinical studies also show that Advair helps reduce the need for rescue medications and patients taking it experience fewer night-time awakenings.

"COPD is a progressively disabling and life-threatening lung disease, primarily caused by smoking," said Dr. Ronald Grossman, Respirologist and Chief of Medicine at Credit Valley Hospital in Mississauga, Ontario. "The goals of management are to slow progression of the disease, effectively diminish the symptoms that significantly impair patients' quality of life and prevent hospitalizations. With the approval of Advair for COPD, physicians and patients now have a new option in helping them to achieve these goals in patients who have already been treated with bronchodilators." According to international guidelines, bronchodilators should be used first in treating COPD to help reduce airway constriction.(3)

The progressive loss of lung function COPD patients experience can have a profound impact on their quality of life. Over time, the airways of those suffering from COPD become obstructed or blocked and the lungs gradually lose their ability to function. Lung function may decline to the point where regular daily activities such as walking and dressing are extremely difficult. Advair contains two medications that work together to treat the inflammation and constriction that occurs in the airways and to improve lung function.

The disease not only places a significant burden on patients but also on the Canadian healthcare system. The annual cost associated with COPD is approximately $2.4 billion, but this is considered to be a conservative estimate due to the under-reporting of the disease, and the lack of data to quantify the impact on the healthcare system.(4) In fact, it is estimated that 75 per cent of COPD sufferers are undiagnosed.(5) The annual cost estimate includes both direct costs (physician visits, hospitalizations, medications, laboratory tests) and indirect costs (work loss due to COPD).

"COPD is a very challenging disease to manage and many patients with this illness often end up in hospital," said Dr. Grossman. "Medications like Advair that help to reduce attacks of breathlessness and provide improved symptom relief are also showing promise in keeping patients out of hospital and at home. In the long-term, improved management of this disease may also contribute to reducing overall treatment costs."

According to the Canadian Lung Association, COPD is the only leading cause of death, other than lung cancer, that continues to rise at a significant rate in Canada. Over the past three decades, statistics show the number of deaths from COPD has quadrupled.(6) "For people suffering from COPD, the simple act of drawing a breath is a constant struggle and often a distressing experience," explained Ross Reid, Vice-President, COPD for the Canadian Lung Association. "With the incidence of the disease on the rise, we welcome and value new treatments that help to make breathing easier for people with COPD."

Advair, taken twice daily using a convenient and easy-to-use dry powder DiskusŪ inhaler device, is well tolerated. The most common side effects patients experience include dysphonia (hoarseness), throat irritation, headache and thrush.

GlaxoSmithKline Inc. – 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. In Canada, GlaxoSmithKline employs more than 1,800 people and is a top 25 investor in Canadian research and development, contributing more than $100 million annually. The company is also one of the top 10 corporate charitable donors, investing more than $7 million annually and is recognized as one of the 50 best companies to work for in Canada.

Advair and Diskus are registered trademarks, used under license by GlaxoSmithKline Inc.

References:

1. Calverley P, Pauwels R, Vestbo J et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003; 361:449-456.
2. Stoller JK. Acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med 2002; 346(13): 988-994.
3. Global Initiative for Chronic Obstructive Lung Disease, National Heart, Lung, and Blood Institute and World Health Organization, 2001.
4. Chapman, K.R et al. The burden of COPD in Canada: results from the Confronting COPD survey. Respiratory Medicine. 2003; 97: S23-S31.
5. Siafakas N.M., Vermeire P, Pride NB, et al. ERS – consensus statement. Optimal assessment and management of chronic obstructive pulmonary disease. Eur Respir Rev 1995; 8: 1398-1420.
6. Canadian Lung Association. Living with COPD, 1998.


SOURCE: GlaxoSmithKline Inc.

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