Inhaled Salmeterol/Fluticasone Propionate Combination

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Abstract
Asthma guidelines recommend an inhaled corticosteroid plus a long-acting inhaled β2-agonist (β2-adrenoceptor agonist) as the preferred maintenance therapy for moderate and severe persistent asthma. Advair®/Seretide® Diskus®, also registered as Accuhaler®, is fixed-dose salmeterol (a long-acting inhaled β2-agonist) and fluticasone propionate (a corticosteroid) administered via a single powder inhalation device. The clinical effectiveness of salmeterol/fluticasone propionate in patients with persistent asthma symptoms has been established in comparative clinical trials. Pharmacoeconomic analyses, based on data from these clinical trials, have been conducted from a healthcare payer perspective in various countries. In patients with asthma not controlled with inhaled corticosteroids, salmeterol/fluticasone propionate was associated with more favourable (lower) cost-effectiveness ratios than fluticasone propionate monotherapy, oral montelukast plus inhaled fluticasone propionate, inhaled budesonide, and inhaled formoterol plus budesonide. As the initial maintenance therapy in patients with persistent asthma symptoms while receiving short-acting β2-agonists alone, salmeterol/fluticasone propionate was cost effective relative to montelukast monotherapy. Although the total cost of asthma management tended to be slightly higher with salmeterol/fluticasone propionate than with fluticasone propionate or montelukast monotherapy, salmeterol/fluticasone propionate consistently had a more favourable cost-effectiveness ratio in terms of per successfully treated week or symptom-free day and/or was associated with small incremental costs to achieve significant additional clinical benefits. In clinical practice, salmeterol plus fluticasone propionate was associated with lower asthma-related costs than treatment with other maintenance therapies. In patients with asthma symptoms despite treatment with inhaled corticosteroids, salmeterol/fluticasone propionate produced clinically meaningful improvements in overall Asthma Quality of Life Questionnaire (AQLQ) scores relative to salmeterol or placebo monotherapy, in emotional function domain scores relative to fluticasone propionate or budesonide, and in asthma symptoms domain scores relative to budesonide. In patients with persistent asthma symptoms while receiving short-acting β2-agonists alone, salmeterol/fluticasone propionate produced clinically meaningful improvements in overall AQLQ scores compared with fluticasone propionate or montelukast. Conclusions: Pharmacoeconomic analyses indicate that salmeterol/fluticasone propionate administered via a single inhaler represents a cost-effective treatment option (relative to fluticasone propionate at the same nominal dosage, budesonide, formoterol plus budesonide and montelukast plus fluticasone propionate) in patients with asthma not controlled with inhaled corticosteroid therapy. In patients with asthma not controlled with short-acting β2-agonists alone, salmeterol/fluticasone propionate is a cost effective treatment relative to monotherapy with montelukast. Importantly, salmeterol/fluticasone propionate is also associated with improvements in health-related quality of life. Asthma, a chronic inflammatory disease of the airways, is among the most common chronic diseases worldwide and is increasing in prevalence. Among affected adults, lung function declines over time to a greater extent, and mortality rates are somewhat higher, than in individuals without asthma. Asthma places a considerable economic burden on affected individuals and society at large. Healthcare costs are approximately twice as high in patients with asthma than in similar patients without asthma. Prescription medications and hospitalisation are the largest contributors to direct healthcare costs; loss of work is the largest contributor to indirect healthcare costs. The cost of treating asthma increases if the underlying disease is severe or poorly controlled. Exacerbations, which result from poor control, may require costly physician and emergency room visits and hospitalisation. The use of appropriate maintenance therapy, although initially increasing drug and physician-based costs, may subsequently reduce direct healthcare costs and indirect costs by improving asthma control. The symptoms of asthma can impair the individual’s health-related QOL (HR-QOL), and many physical activities, along with emotional and social aspects of a patient’s life, may be limited by the disease. A stepwise approach to treatment based on the underlying severity of asthma symptoms is recommended in recent global asthma treatment guidelines to control symptoms and maintain normal activity levels. Use of an inhaled corticosteroid plus a long-acting inhaled β2-agonist β2-adrenoceptor agonist) is the preferred controller therapy in patients with moderate and severe persistent asthma. The long-acting inhaled β2-agonist salmeterol and the corticosteroid fluticasone propionate are administered in a single powder Diskus® (Accuhaler®) inhalation device, hereafter referred to as salmeterol/fluticasone propionate. The combination appears to have complementary effects and targets both smooth muscle dysfunction and inflammation. In randomised, double-blind, comparator-controlled, multicentre trials in patients with asthma that were used as the basis for pharmacoeconomic analyses, salmeterol/fluticasone propionate was at least as effective clinically as other combination asthma treatments. Salmeterol/fluticasone propionate twice daily for 12 weeks was more effective in improving most measures of lung function and asthma symptom outcomes than monotherapy twice daily with its individual components at the same nominal dosage in patients with asthma symptoms despite existing treatment with inhaled...