Inhaled salmeterol/fluticasone propionate combination - A review of its use in persistent asthma

The long-acting beta (2)-agonist salmeterol and the corticosteroid fluticas one propionate are available as a combination inhalation device for the tre atment of persistent asthma. Well designed studies in adults, adolescents and children aged greater than or equal to4 years, demonstrate that combined salmeterol/fluticasone propi onate 50/100, 50/250 and 50/500 mug administered via a dry powder inhaler ( DPI) is clinically equivalent to concurrent delivery of the same dosages of the 2 drugs via separate DPIs. In adults and adolescents, combined salmeterol/fluticasone 50/100 and 50/25 0 mug twice dairy produced rapid improvements in lung function that were co nsistently greater than those in patients receiving monotherapy twice daily salmeterol 50 mug, fluticasone propionate 100 or 250 mug or placebo in 2 w ell designed studies. Recipients of the combination had a significantly gre ater probability of completing 12 weeks of treatment than patients receivin g monotherapy or placebo. The combination also produced significant improve ments between baseline and end-point in air secondary outcome variables (mo rning and evening peak expiratory flow, daytime symptom scores, days and ni ghts without asthma symptoms and requirements for as-needed beta -agonists) and health-related quality of life (QOL). Combination therapy was superior to monotherapy with salmeterol and placebo for all outcomes in both studie s, and was superior to fluticasone propionate 100 mug for all but 1 outcome (nights without awakenings) in 1 study. Similar results were obtained in p atients who had previously been using short acting beta (2)-agonists alone. Combined twice daily salmeterol/fluticasone propionate 50/100 and 50/250 mu g produced greater improvements in lung function than inhaled budesonide at higher dosages than fluticasone propionate in the combination. Combined salmeterol/fluticasone propionate 50/250 mug produced similar impr ovements in lung function to concurrent budesonide 800 mug plus formoterol 12 mug when given twice daily for 12 weeks. In another 12-week trial, combi ned salmeterol/fluticasone propionate 50/100 mug was more effective than or al montelukast 10 mg/day plus fluticasone propionate 100 mug twice daily in patients with suboptimally controlled asthma. Salmeterol/fluticasone is more cost effective than monotherapy with flutica sone propionate or budesonide. The most frequent adverse events associated with salmeterol/fluticasone pro pionate are headache, throat irritation, hoarseness and candidiasis. Conclusion: Combined salmeterol/fluticasone propionate is as effective as t he 2 drugs given concurrently via separate inhalers and significantly more effective than either drug given alone at the same nominal dosage. The comb ination is also significantly more effective than montelukast plus fluticas one propionate or monotherapy with inhaled budesonide. Furthermore, the com bination is more cost effective than inhaled corticosteroid monotherapy.