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| |  CHEST 99: Asthma Study Shows Flovent Superior to Accolate For Asthma Treatment CHICAGO, IL -- November 2, 1999 -- A study presented yesterday (Nov. 1) at CHEST 1999, the 65th annual conference of the American College of Chest Physicians, found that treatment with Flovent(R) (fluticasone propionate) Inhalation Aerosol (44 mcg, 2 puffs twice daily), an inhaled corticosteroid, resulted in significantly greater improvements in measures of lung function and symptom control when compared to Accolate(R) (zafirlukast) (20 mg, twice daily), a leukotriene modifier. Asthma treatment guidelines developed by the National Heart, Lung, and Blood Institute recommend inhaled corticosteroids as the "the most effective long-term control medicine for persistent asthma."(1) In the six-week study presented yesterday at CHEST 1999 by Dr. Kathy Rickard, director of U.S. Respiratory Medical Affairs at Glaxo Wellcome, a low dose of Flovent (2 puffs, 44 mcg; twice daily), was superior to zafirlukast (20 mg; twice daily) in numerous efficacy measures. Compared to patients taking zafirlukast, those using Flovent experienced significantly greater improvements in lung function as measured by FEV1 (the volume of air exhaled in one second) and morning peak flow. They also experienced significantly more symptom-free days and fewer asthma exacerbations. Finally, patients taking Flovent were able to reduce their use of albuterol (rescue medicine) as opposed to patients taking zafirlukast who had to increase their use. Dr. Rickard said: "This study had two significant conclusions. First, the study showed that Flovent Inhalation Aerosol, at a dose of 44 mcg 2 puffs twice daily, was a more effective therapy than zafirlukast for asthma patients who were previously taking the inhaled corticosteroids triamcinolone or beclomethasone. Second, this study provides evidence that, for patients with stable, persistent asthma who are taking low dose of inhaled corticosteroids, switching to a low dose of Flovent may result in improved asthma control compared to switching to zafirlukast. Switching these patients to zafirlukast may result in worsening asthma control, as indicated by more frequent asthma exacerbations with zafirlukast as compared to Flovent." The study, supported by Glaxo Wellcome and conducted at 44 outpatient centers, was a randomized, double-blind, double-dummy parallel group multicenter study, in 440 patients 12 years of age or older. Patients using a fixed dose of beclomethasone dipropionate (168 to 339 mcg) daily or triamcinolone (400 to 800 mcg) daily for four or more weeks were randomized to Flovent (88 mcg) Inhalation Aerosol twice daily or zafirlukast (20 mg) twice daily for six weeks. The results of this study were replicated by another study of the same design involving 437 asthma patients. Asthma is a chronic lung disease characterized by inflammation of the lower airways and bronchoconstriction (the tightening of muscles in the walls of these airways). Both components of the disease restrict airflow into and out of the lungs, making it difficult for people to breathe. In people with persistent asthma, inflammation is always present to some degree even when not symptomatic. When left untreated, inflammation contributes to decreased lung function, symptoms of asthma, and possible long-term lung damage. Current National Heart, Lung, and Blood Institute asthma guidelines identify inhaled corticosteroids as the most effective anti-inflammatory agents available for mild- to severe-persistent asthma. Inhaled corticosteroids deliver a small amount of medicine directly to the lungs. Flovent is the most prescribed brand of inhaled corticosteroid in the United States.(2) In the study presented today, 224 patients received fluticasone and 216 received zafirlukast. Demographic and baseline patient symptoms were similar in the two groups. Significantly fewer (P=0.006) asthma exacerbations occurred with fluticasone (n=2) as compared to zafirlukast (n=12). Exacerbations were defined as any worsening of asthma symptoms requiring a change in the subject's current asthma therapy. Only one patient treated with Flovent Inhalation Aerosol had an asthma exacerbation requiring treatment with oral corticosteroids compared with ten patients treated with zafirlukast (p=0.005). There were no differences in the incidence of post-randomization adverse events between the two treatment arms. Flovent Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. It 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. The most common adverse events (> 3 percent) in controlled clinical studies with Flovent 88 mcg twice daily were: headache (17 percent), upper respiratory infection (15 percent), pharyngitis (10 percent), nasal congestion (8 percent), nasal discharge (5 percent), allergic rhinitis (5 percent) and dysphonia (4 percent). CAUTION: Adrenal insufficiency may occur when transferring patients from systemic steroids.
References: (1) National Heart, Lung, and Blood Institute, National Institutes of Health. Practical Guide for the Diagnosis and Management of Asthma. October 1997. (NIH Publication No. 97-4053.) (2) Source(TM) Prescription Audit (SPA), New retail prescriptions dispensed in October 1998. Scott-Levin, Inc.
Related Links: Accolate(R) (zafirlukast) and Flovent(R) (fluticasone propionate) Inhalation Aerosol .
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