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| |  Low-Dose Flovent (Fluticasone) More Effective Than Singulair (Montelukast) In Key Measures Of Asthma Control RESEARCH TRIANGLE PARK, NC -- March 19, 2001 -- A study published in the March issue of the Journal of Allergy and Clinical Immunology showed that Flovent® (fluticasone propionate) Inhalation Aerosol (44 mcg, 2 puffs twice daily) was significantly more effective than Singulair® (montelukast, 10 mg once daily) at improving key measures of asthma control.(1) Flovent, an inhaled corticosteroid, was shown to be more effective than Singulair, a leukotriene modifier, at reducing asthma symptoms, improving lung function, and reducing the use of rescue albuterol in patients 15 years of age and older who remained symptomatic on short-acting beta-agonists alone. 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 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, released in 1997, the role of leukotriene modifiers in step-wise therapy for asthma has not been fully established. "The study found that even at its lowest indicated dose, Flovent was more effective than Singulair as a first-line maintenance therapy for patients with persistent asthma," said Kathleen A. Rickard, M.D., vice president of clinical development respiratory, North American Medical Affairs at GlaxoSmithKline. "The data suggest that Flovent is an effective first-line long-term controller therapy, not just for moderate or severe asthma patients, but also for people with milder asthma." Milder asthma was defined as baseline FEV1 >70 percent of predicted. 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 533 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 for 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 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, p<0.001). At baseline, patients were symptom-free for 1.9 percent and 2.3 percent of the time for Flovent and Singulair, respectively.(1) (The mean number of treatment days for Flovent and Singulair was 142 and 144 respectively.) * Improving lung function: Flovent provided 54 percent greater improvement in FEV1 from baseline compared to Singulair (at study endpoint, an improvement of 22.87 percent for Flovent, compared with 14.47 percent for Singulair, p<0.001). Flovent was more than twice as effective than Singulair in improving AM PEF (at study endpoint, an improvement of 68.5 L/min for Flovent compared with an improvement of 34.1 L/min for Singulair, p<0.001). Baseline FEV1 for Flovent and Singulair was 2.33 L and 2.35 L, respectively. Baseline AM PEF for Flovent and Singulair was 349.6 L/min and 357.8 L/min, respectively.(1) * Reducing rescue albuterol use: Flovent provided 49 percent more days requiring no rescue albuterol compared to Singulair (62.1 days with Flovent; 41.6 with Singulair, p<0.001). Baseline percentage of rescue- free days was 2.5 percent for Flovent and 2.5 percent for Singulair. (The mean number of treatment days for Flovent and Singulair was 142 and 144 respectively.)(1) Furthermore, Flovent patients were significantly more satisfied with their therapy: 85 percent of patients taking Flovent were satisfied with therapy as compared to 65 percent satisfaction for patients taking Singulair. In this study, using Juniper's Asthma Quality of Life Questionnaire(3), Flovent had significantly greater improvement in asthma related quality of life than Singulair; however, the difference between the two treatment groups did not reach the clinically meaningful improvement of 0.5, which represents the smallest difference that patients perceive as beneficial.(4) No statistically significant differences were seen between Flovent and montelukast for withdrawals due to lack of efficacy and subject productivity. 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. Patients and physicians should be cautioned that adrenal insufficiency may occur when transferring patients from systemic steroids. Flovent Inhalation Aerosol 44 mcg 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).
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