Efficacy of the combination of fluticasone propionate and salmeterol in patients with moderate persistent asthma within a "real-life" setting.

ABSTRACT

There are only few data on the effectiveness of recommended drug therapies in asthma under "real-life" conditions without targeted intervention. The study aimed at analyzing the efficacy of the fixed combination of the inhaled corticosteroid fluticasone propionate and the long-acting beta2-agonist salmeterol (FS) for maintenance treatment of moderate persistent asthma (GINA stage 3) within an observational design, mimicking "real-life" as closely as possible. The fixed combination was compared with other forms of treatment that were in accordance with treatment guidelines (pooled comparison (PC) group). Patients kept a diary during a 12-month observation period and routine visits were taken for surveillance. Among 596 patients, 371 patients belonged to the FS and 225 patients to the PC group. The proportion of symptom-free days (SFD) was higher in the FS than PC group (median, 76 vs 67%; p=0.002). Furthermore, the change in asthma control score (p<0.0001) and the percent increase in FEV1 (p<0.05) after 12 months were greater. There was a lower percentage of patients with hospital stays (p<0.05). The proportions of episode-free or sick-leave days and the number of routine or emergency visits did not significantly differ between groups. Direct costs of treatment per SFD were lower in the FS than PC group (median, 3.78 vs 4.41 Euro; p<0.05). We conclude that in a setup close to clinical practice treatment of patients with moderate persistent asthma with the fixed combination of fluticasone propionate and salmeterol has beneficial effects compared to other forms of therapy and can improve cost-efficiency.