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| |  AAAAI: Combination Fluticasone /Salmeterol Effective as Inhaled Corticosteroid Sparing Agent By Paula Moyer DENVER, CO -- March 10, 2003 -- Combination therapy consisting of fluticasone (Flovent) and salmeterol (Serevent) is an effective steroid-sparing therapy for patients who need a moderate dose of an inhaled corticosteroid to control their asthma, according to an analysis of two replicate, randomised, double-blind, parallel group studies. Paul Dorinsky, MD, of GlaxoSmithKline, presented the findings on Flovent, an inhaled corticosteroid, and Serevent, a long-acting beta-agonist, here March 9th at the 60th Annual Meeting of the American Academy of Allergy, Asthma, and Immunology. In their studies, Dr. Dorinsky and colleagues found that patients on this regimen were able to reduce their dose of inhaled corticosteroids by 60% and still have well-controlled asthma. "The effectiveness of this therapy as a steroid-sparing agent was sustained following long-term administration," said Dr. Dorinsky, also noting that the investigators observed no tachyphylaxis, a phenomenon that has occasionally been observed with long-acting beta-agonists. In the studies, the investigative team sought to evaluate the long-term effectiveness of the combination regimen as an inhaled corticosteroid-sparing agent in patients requiring a moderate dose of an inhaled corticosteroid for asthma control. The follow-up period was six months. The researchers randomised 596 patients to 24 weeks of treatment -- 307 patients received 100 mcg of fluticasone and 50 mcg of salmeterol twice daily, and 289 patients received 250 mcg of fluticasone monotherapy twice daily. Treatment was administered through a discus-type dry-powder inhaler, a delivery system that is widely used for the combined fluticasone and salmeterol therapy (Advair). The mean baseline forced expiratory volume in one second (FEV1) was 81% of predicted for each group. Over 12 weeks of therapy, the investigators noted that 5% of patients withdrew due to lack of efficacy in the group receiving fluticasone and salmeterol, and that 10% of the patients in the fluticasone monotherapy patient withdrew for this reason (p=0.013). After 24 weeks of therapy, discontinuation rates due to lack of efficacy were 8% with combination therapy and 14% with monotherapy (p=0.013). The investigators also observed significantly greater improvements in FEV1, morning peak expiratory flow, albuterol use, and the percent of symptom-free days in the combination group compared with the monotherapy group after 12 weeks of therapy (p-/=0.039). They reported that these improvements continued after 24 weeks of therapy (p-/=0.043). Both treatments were well tolerated and the profile of adverse events observed during the first 12 weeks and the last 12 weeks were similar between and within treatment groups, Dr. Dorinsky said. GlaxoSmithKline provided funding for this study.
[Study title: Long-Term Effectiveness of the Fluticasone Propionate/Salmeterol (FSC) 100/50 mcg Combination Product as an Inhaled Corticosteroid Sparing Agent. Abstract 224]
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