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| |  AAFP: Flovent (Fluticasone Propionate) More Effective Than Singulair (Montelukast) In Reducing Asthma Symptoms DALLAS, TEXAS -- September 20, 2000 -- A study presented at the Scientific Assembly of the American Academy of Family Physicians (AAFP) showed that Flovent® (fluticasone propionate) Inhalation Aerosol (44 micrograms, two 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 symptomatic on short-acting beta-agonists. In addition, patients taking Flovent were significantly more satisfied with therapy than patients taking montelukast. 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 step-wise therapy for asthma has not been fully established. "The study results were conclusive: "Low-dose Flovent was found to be more effective than Singulair at controlling asthma," said Dr. Lou Kuritzky, clinical assistant professor at the University of Florida College of Medicine, who discussed the findings at a panel discussion on how primary care providers can most effectively manage asthma and other respiratory diseases. An estimated 50 to 60 percent of asthma patients go to primary care providers, including family and general practioners, most often for their asthma care.(3) "The study found that even at its lowest indicated dose, Flovent was more effective than Singulair at improving lung function -- even among those with milder degrees of asthma. Flovent was also more effective at decreasing the number of days that people used their rescue albuterol and experienced asthma symptoms," Dr. Kuritzky said. Milder asthma was defined as >70 percent of predicted FEV1 (Forced Expiratory Volume in one second, a standard measure of lung function). The multicenter, randomized, double-blind, double-dummy, parallel group study compared Flovent 44 micrograms (two puffs, twice daily) vs. Singulair (10 mg once daily) in a 24-week trial involving 533 subjects 15 years of age and older. Eligible patients had been diagnosed with asthma for at least six months, had a baseline FEV1 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.(1) The study showed that Flovent was significantly more effective than Singulair at: * Reducing asthma symptoms: Flovent provided 62 percent more days with no asthma symptoms compared to Singulair (39.3 days with Flovent; 24.3 days with Singulair). At baseline, patients were symptom-free for 1.9 percent and 2.3 percent of the time for Flovent and Singulair, respectively. (Duration of study was approximately 184 days.)(1) Furthermore, patients taking Flovent were significantly more satisfied with their therapy than Singulair patients: 85 percent of patients taking Flovent were satisfied with therapy as compared to 65 percent 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(4), 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.(5) In the second replicate study, no statistically significant differences were seen between the two patient groups for withdrawals due to lack of efficacy or for subject productivity. The panel discussion was part of the launch of the AAFP's 2001 Annual Clinical Focus, which is on asthma, allergy and respiratory infections. The Annual Clinical Focus is AAFP's educational initiative designed to bring members state-of-the-art information on a specific subject area each year to assist the members in providing comprehensive patient care. 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 can cause damage to the airways, leading to a worsening of lung health and a decline in lung function.(6) An estimated 17 million Americans have asthma, and this number has risen dramatically in recent years.(7) 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. 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.(8) Furthermore, the regular use of low-dose inhaled corticosteroids has been associated with a significant decreased risk of asthma-related death.(9) Although the precise mechanism of action of inhaled corticosteroids and leukotriene modifiers is not known, corticosteroids have demonstrated their anti-inflammatory effect on a number of the cell types involved in the asthmatic response. In contrast, the mechanism of action of leukotriene modifiers is narrow and targeted only at either the action or the production of leukotrienes. "Inhaled corticosteroids are a key component of proper asthma treatment," said Dr. Bob Lanier, a nationally recognized allergist, vice president of the American College of Allergy, Asthma & Immunology, and one of the investigators on the study. "With this important data, perhaps physicians will take a closer look at the significant benefits offered by inhaled corticosteroids as a first-line long-term controller therapy, not just for moderate or severe asthma patients, but for people with milder cases as well." 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 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. References Related links: Singulair, Flovent.
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