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| |  ATS: Flovent (Fluticasone) More Effective Than Accolate (Zafirlukast) in Improving Asthma Control TORONTO, ON -- May 8, 2000 -- A study presented this week at the 96th International Conference of the American Thoracic Society (ATS) shows that Flovent(R) 44 mcg (fluticasone propionate) Inhalation Aerosol, an inhaled corticosteroid, was significantly more effective than Accolate(R) (zafirlukast), a leukotriene modifier, at improving asthma control. These findings are based on the evaluation of 865 patients -- across two clinical trials -- who were previously taking older inhaled corticosteroids. These findings appear to be consistent with the asthma treatment guidelines developed by the National Heart, Lung, and Blood Institute (NHLBI), which recommend inhaled corticosteroids as the "most effective long-term control medicine for persistent asthma". According to these same guidelines, the role of leukotriene modifiers in step-wise therapy for asthma has not been fully established. "When we looked at this research, we found that Accolate was not as effective as Flovent 44 mcg in managing asthma," said Kathy Rickard, MD, director of U.S. Respiratory Medical Affairs at Glaxo Wellcome Inc. "Flovent has been shown to be more effective than Accolate at improving lung function, reducing symptoms, and reducing use of rescue medications, all of which are key indicators of good asthma management." Presented today at ATS, the study -- two replicate six-week, multi-center, randomized, double-blind, double-dummy, parallel group clinical trials -- compared the effects of Flovent vs. Accolate in 865 patients 12 and older. Eligible patients had taken a fixed dose of beclomethasone (BDP; mean total daily dose = 265 mcg/day) or triamcinolone (TAA; mean total daily dose = 581 mcg/day) and had a baseline FEV1 60-80 percent of predicted. After an eight-day run-in period, BDP and TAA were discontinued, and patients were randomized to Flovent 88 mcg twice daily or Accolate 20 mg twice daily. The study showed that switching patients from a fixed dose of BDP or TAA to the lowest dose of Flovent Inhalation Aerosol (44 mcg, 2 puffs, BID) improved asthma control, while switching to Accolate 20 mg BID resulted in worsening asthma control: -Albuterol use: decreased 0.62 puffs/day for Flovent and increased 0.19 puffs/day for Accolate. -Asthma exacerbations: significantly fewer patients (p<0.001) experienced asthma exacerbations with Flovent (n=7) as compared to Accolate (n=26). -Withdrawals due to lack of efficacy: were reported for 10 (2 percent) patients on Flovent and 60 (14 percent) patients on Accolate. The study also showed that Flovent was associated with a greater increase in lung function, as measured by FEV1 and morning peak flow, than Accolate. Flovent also was associated with a higher percentage of symptom-free days than Accolate. "This study demonstrated that removing inhaled corticosteroids from a patient's treatment regimen and putting Accolate in its place may result in a worsening of asthma control," said Dennis P. Clifford, MD., lead author of the study and a pulmonologist at Rocky Mountain Pulmonary Care and Critical Care Medicine in Wheat Ridge, Colorado. "This is important for physicians to consider when choosing a controller medication for their patients." Asthma is a disease that affects 17 million Americans. Inflammation (swelling and redness) in the lungs' airways is one of the most important causes of asthma symptoms and can lead to recurrent episodes of wheezing, shortness of breath, chest tightness and coughing, particularly at night and in the early morning. In patients with persistent asthma, this inflammation is always present to some degree -- even when there are no symptoms. If not treated appropriately, inflammation can cause damage to the airways, leading to a worsening of lung health and a decline in lung function. According to asthma treatment guidelines developed by the National Heart, Lung, and Blood Institute (NHLBI), the most effective long-term control medications for asthma are those that reduce inflammation. These same guidelines recommend inhaled corticosteroids as the "most effective long-term control medication" for persistent asthma in patients 5 years of age and older. (People with persistent asthma are those who experience symptoms more than twice a week.) The daily use of inhaled corticosteroids can help reduce asthma symptoms, reduce the occurrence of asthma attacks (exacerbations), decrease the need for quick-relief medication, and improve lung function. Inhaled corticosteroids may be associated with a substantial decrease in the risk of hospitalization due to asthma. According to the same NHLBI guidelines, "leukotriene modifiers may be considered an alternative to low-dose inhaled corticosteroid therapy for patients with mild persistent asthma, although increased clinical experience and further study in a wide range of patients are needed to determine those patients most likely to benefit from leukotriene modifiers and to establish a more specific role for leukotriene modifiers in (step-wise) therapy". Flovent Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy for patients 12 years of age and older. Flovent is also indicated for patients requiring oral corticosteroid therapy for asthma; many of these patients may be able to reduce their requirement for oral corticosteroids over time. Flovent Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. Flovent 44 mcg Inhalation Aerosol has been studied extensively and has a favorable safety profile at recommended doses. The most common adverse events in controlled clinical studies with Flovent at up to 440 mcg twice daily were: headache (17-22 percent), upper respiratory infection (15-22 percent), pharyngitis (10-14 percent), nasal congestion (8-16 percent), influenza (3-8 percent) and sinusitis (3-6 percent). Patients and physicians should be cautioned that adrenal insufficiency may occur when transferring patients from systemic steroids. Flovent, the world's leading brand of inhaled anti-inflammatory medication, was developed and is marketed by Glaxo Wellcome Inc., an industry leader in respiratory research. The company has a broad portfolio of commercially available respiratory therapies. Related Links: Accolate (zafirlukast), Flovent (fluticasone propionate) and Glaxo Wellcome Inc.
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