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| |  FDA Approves Dual-Action Advair Diskus (Fluticasone Propionate And Salmeterol) For Asthma RESEARCH TRIANGLE PARK, NC -- August 25, 2000 -- The U.S. Food and Drug Administration (FDA) has approved the first and only asthma medication that simultaneously treats both of the underlying components of the disease: inflammation and bronchoconstriction. The new medication will offer many asthma patients an effective and convenient approach to treating their condition, improving their lung function and helping control their symptoms. Advair™ Diskus® (fluticasone propionate and salmeterol inhalation powder) is the first and only dual-action asthma medication to be approved for use in the United States. It contains an inhaled corticosteroid (fluticasone propionate) to reduce swelling and irritation inside the lungs' airways (inflammation), and an inhaled long-acting bronchodilator (salmeterol) to help prevent tightening of the muscles that surround the airways (bronchoconstriction). Together, inflammation and bronchoconstriction cause asthma symptoms, including shortness of breath, wheezing, chest tightness, and coughing. Advair Diskus is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 12 years of age and older. It is not indicated for the relief of acute bronchospasm. "With the approval of Advair Diskus, we have a medicine that can have a major impact on asthma management," said Dr. Stuart Stoloff, clinical associate professor of family and community medicine at the University of Nevada, and a member of the expert medical panel that helped develop current national asthma treatment guidelines. "It can help people control their asthma by getting to the root of the problem -- treating asthma's two components at once, and literally in the same breath. It's like giving asthma the one-two punch." Patients take one inhalation twice a day, once in the morning and once at night, from the Diskus, a breath-activated powder inhaler. For many of the 17 million Americans with asthma, undertreatment can mean frequent symptoms and attacks, missed work and school, activity limitations, and a decline in lung health and function. Along with education about proper asthma management, effective and easy-to-use medications are a crucial part of keeping asthma under control and lessening the impact of the disease. Advair Diskus represents an evolution in thinking about effective asthma management. Most asthma treatments have been designed to either relieve bronchoconstriction, by relaxing the smooth muscle surrounding the airways, or reduce airway inflammation, by blocking cellular processes that can lead to chronic swelling and irritation in the airways. However, research has revealed that both bronchoconstriction and inflammation play crucial roles in the disease and that both contribute to asthma symptoms. Hence the dual-component approach of Advair Diskus. Current national asthma treatment guidelines, published by the National Heart, Lung, and Blood Institute,(1) recommend using an inhaled long-acting bronchodilator with inhaled corticosteroids as one of the preferred treatment options for asthma patients who have daily symptoms. Clinical trials with Advair Diskus 100/50 and Advair Diskus 250/50 showed that treating both components of asthma (inflammation and bronchoconstriction) was associated with greater asthma control than either fluticasone propionate or salmeterol inhalation powders alone at the same doses. Trials involving more than 1,200 patients evaluated several measures -- including lung function, protection against worsening asthma, rescue medication use, symptoms, and nighttime awakenings due to asthma. Following is a summary of trial results(2) for Advair Diskus 100/50 (fluticasone propionate 100mcg and salmeterol 50mcg), the lowest strength of the medication: Protection against worsening asthma: Only three percent of patients taking Advair Diskus 100/50 withdrew from the study because their asthma was getting worse, compared to 11 percent for fluticasone propionate 100mcg alone and 35 percent for salmeterol 50mcg alone. The trial criteria for worsening asthma included a decrease in lung function, an increase in the use of rescue albuterol, and an emergency room visit or hospitalization due to asthma. Other endpoints that were measured in this study included: Symptom reduction: Patients taking Advair Diskus 100/50 had nearly twice as many symptom-free days (48 percent) at study endpoint compared to baseline as those taking fluticasone propionate 100mcg alone (27 percent) and salmeterol 50mcg alone (21 percent). Albuterol use: Advair Diskus 100/50 resulted in a reduction in use of rescue albuterol that at study endpoint compared to baseline was more than six times greater than salmeterol 50mcg alone and more than four times greater than fluticasone propionate 100mcg alone. Onset of action: Approximately half of all patients who received Advair Diskus 100/50 had clinically significant improvement in lung function (greater than or equal to 15 percent improvement in FEV1) within 30 minutes of taking the first dose; approximately two-thirds of all patients demonstrated greater than or equal to 15 percent improvement in FEV1 within one hour. (It is important to remember, however, that Advair Diskus will not replace fast-acting inhalers used for sudden attacks.) Nighttime awakenings were also evaluated in this study. Despite little room for improvement, Advair Diskus 100/50 further increased the percentage of nights without awakenings compared to fluticasone propionate and salmeterol alone at the same doses. These differences were significant versus salmeterol, and they approached, but did not reach, statistical significance versus fluticasone propionate. Trials with Advair Diskus showed that it was generally well tolerated and had a favorable safety profile similar to that of its individual components given concurrently at the same doses. The most common side effects (greater than or equal to 8 percent) observed in the studies were upper respiratory tract infection, sore throat, viral respiratory infection, bronchitis and headache. Advair Diskus should not be used for transferring patients from oral corticosteroid therapy. Particular care is needed for patients who have been transferred from oral corticosteroids to inhaled corticosteroids because, while adjusting to the switch, a patient may not be able to heal after surgery, infection, or serious injury. Advair Diskus should not be used to relieve acute asthma symptoms. Patients should be prescribed a short-acting beta-agonist (e.g., albuterol) when acute symptoms occur. Also, Advair Diskus should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. Advair Diskus will be available in three strengths: Advair Diskus 100/50, Advair Diskus 250/50 and Advair Diskus 500/50. Each contains 50mcg of salmeterol and either 100mcg, 250mcg or 500mcg of fluticasone propionate. powder). References (2) Kavuru M, Melamed J, Gross G, and et al. "Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial." J Allergy Clin Immunol. 2000 June; 105 (6, Part 1):1108-1116.
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