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| |  ACAAI: Low-Dose Flovent (Fluticasone Propionate) Aerosol More Effective Than Singulair (Montelukast) In Key Measures Of Asthma Control SEATTLE, WA -- November 7, 2000 -- A study presented at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) showed that Flovent® (fluticasone propionate) Inhalation Aerosol (44 mcg, 2 puffs twice daily), an inhaled corticosteroid, was significantly more effective than Singulair® (montelukast, 10 mg once daily), a leukotriene modifier, at improving key measures of asthma control.(1) Flovent was shown to be more effective than Singulair at reducing asthma symptoms, improving lung function, and reducing the use of rescue albuterol in patients 15 years of age and older whose asthma was not controlled by short-acting beta-agonists alone. In addition, patients taking Flovent were more satisfied with therapy than patients taking Singulair. Asthma treatment guidelines developed by the National Heart, Lung, and Blood Institute (NHLBI), recommend inhaled corticosteroids as the "most effective long-term control medicine" for persistent asthma for people five years of age and older.(2) According to these same guidelines, which were released in 1997, the role of leukotriene modifiers in asthma therapy has not been fully established. "The study results were clear: Low-dose fluticasone was found to be more effective than montelukast as first line maintenance therapy in patients with persistent asthma," said Dr. Eli Meltzer, clinical professor of pediatrics at the University of California, San Diego, and lead author on the study. "This is important information for physicians who are considering how best to treat their patients with persistent asthma -- especially those with milder cases." The multi-center, randomized, double-blind, double-dummy, parallel group study compared Flovent 44 mcg (2 puffs, twice daily) vs. Singulair (10 mg once daily) in a 24-week trial involving 522 subjects 15 years of age and older whose asthma was not optimally managed. Eligible patients had been diagnosed with asthma for at least six months, had a baseline FEV1 (Forced Expiratory Volume -- a standard measure of lung function) that was 50-80 percent of predicted normal, used short-acting beta-agonists for six of the previous seven days, and experienced two or more asthma symptoms on four or more of the previous seven days. In addition, subjects had not used inhaled corticosteroids two months prior to -- or systemic corticosteroids three months prior to -- enrollment. The primary efficacy endpoint was morning pre-dose FEV1 (obtained at the end and middle of the dosing interval for Flovent and Singulair, respectively).(1) The study showed that Flovent was more effective than Singulair at: * Reducing asthma symptoms: Flovent treatment reduced symptom scores and nighttime awakenings, and produced 70 percent more days with no asthma symptoms compared to Singulair (46.2 days with Flovent; 27.1 days with Singulair). At baseline, patients were symptom-free for 2.4 percent and 1.6 percent of the time for Flovent and Singulair, respectively. (Duration of study was approximately 168 days.)(1) * Reducing rescue albuterol use: Flovent treatment resulted in 46 percent more days with no rescue albuterol use compared to Singulair (66.3 with Flovent; 45.5 with Singulair). Baseline percentage of rescue-free days was 3.1 percent for Flovent and 1.9 percent for Singulair.(1) * Improving lung function: Even at its lowest indicated dose, Flovent was more effective than Singulair at improving lung function -- even among those with milder degrees of asthma. Milder asthma was defined as baseline FEV1 >70 percent of predicted. Flovent provided 57 percent greater improvement in FEV1 from baseline compared to Singulair. In patients with milder asthma, Flovent was 93 percent more effective than Singulair at improving morning PEF (Peak Expiratory Flow, a standard measure of lung function). Baseline FEV1 for Flovent and Singulair was 2.32L and 2.40L, respectively. Baseline morning PEF for Flovent and Singulair was 349.2L/min and 357.7L/min, respectively.(1) Furthermore, patients taking Flovent were significantly more satisfied with their therapy than Singulair patients: 83 percent of patients taking Flovent were satisfied with therapy as compared to 66 percent patient satisfaction for patients taking Singulair. The study presented was one of two replicate studies comparing Flovent Inhalation Aerosol and Singulair. Both showed similar results. In each study, using Juniper's Asthma Quality of Life Questionnaire(3), Flovent had a significantly greater improvement in asthma related quality of life than Singulair; however, the difference between the two treatment groups did not reach 0.5, which represents the smallest difference that patients perceive as beneficial.(4) In the study presented today at ACAAI, no statistically significant differences were seen between the two patient groups for withdrawals due to lack of efficacy or for subject productivity. Inflammation is an important underlying cause of asthma symptoms, including shortness of breath, wheezing, chest tightness, and cough. In patients with persistent asthma (i.e., symptoms more than twice a week), this inflammation is always present to some degree. If left untreated, inflammation may cause damage to the airways, leading to a worsening of lung health and a decline in lung function.(5) Although the precise mechanism of action of inhaled corticosteroids and leukotriene modifiers in asthma is not known, corticosteroids have demonstrated their anti-inflammatory effect on a number of the cell types and mediators (including leukotrienes) involved in the asthmatic response. In contrast, the mechanism of action of leukotriene modifiers is targeted only at either the action or the production of leukotrienes. "This is the latest in a series of studies that show that inhaled corticosteroids are an important part of helping to keep asthma under control," continued Dr. Meltzer. "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.(6) Furthermore, the regular use of low-dose inhaled corticosteroids has been associated with a significantly decreased risk of asthma-related death.(7) An estimated 17 million Americans have asthma, and this number has risen dramatically in recent years.(8) Undertreatment of the disease can mean frequent symptoms and attacks, emergency room visits and hospitalizations, missed work and school, activity limitations, and a decline in lung health and function. Flovent Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy for patients 12 years of age and older. 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%), upper respiratory infection (15-22%), pharyngitis (10-14%), nasal congestion (8-16%), influenza (3-8%) and sinusitis (3-6%). Patients and physicians should be cautioned that adrenal insufficiency may occur when transferring patients from systemic steroids. References:
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