Salmeterol/fluticasone propionate combination therapy 50/250 μ g twice daily is more effective than budesonide 800 μ g twice daily in treating moderate to severe asthma

Abstract

Three hundred and fifty-three asthmatic patients who remained symptomatic despite treatment with budesonide 800-1200 microg day(-1) (or equivalent) were randomized to a new combination therapy comprising salmeterol 50 microg and fluticasone propionate 250 microg (Seretide, Advair, Viani 50/250 microg) twice daily or budesonide 800 microg twice daily for 24 weeks. Patients kept daily records of their morning and evening peak expiratory flow (PEF), daytime and night-time symptom scores and daytime and night-time use of rescue salbutamol. Mean morning PEF increased by 451 min(-1) (baseline 361 l min(-1)) in the salmeterol/fluticasone propionate combination (SFC) group and by 19 l min(-1) (baseline 358 l min(-1)) in the budesonide group over the 24 weeks. The adjusted mean morning PEF over weeks 1 to 24 was significantly greater in the SFC group, despite the > three-fold lower corticosteroid dose (406 vs. 380 l min(-1); P < 0.001). A significantly greater improvement in evening PEF was also seen in the SFC group (adjusted mean 416 vs. 398 l min(-1); P<0.001). SFC also provided significantly better control of daytime symptoms and a significantly greater reduction in the requirement for rescue salbutamol compared with budesonide. These results demonstrate that SFC 50/250 microg twice daily is superior to budesonide 800 microg twice daily in the management of patients with moderate to severe asthma who are symptomatic on their existing dose of corticosteroid.

Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and over

“…Although patients receiving FP/SAL had a significantly reduced need for rescue medication, the trials were statistically heterogeneous and this difference did not remain when the data were analysed in a random-effects model. [223][224][225] evaluated BUD compared with FP/SAL combination therapy ( Table 46). All three studies were multi-centre trials with two-arm parallel designs.…”

“…The third study, by Jenkins and colleagues, 223 compared the combination of 500 µg/100 µg/day FP/SAL with 1600 µg/day BUD (representing a high dose of BUD). All doses reported here are ex-valve.…”

“…Two studies also used a placebo Turbuhaler with the FP/SAL treatment and a placebo Diskus inhaler with the BUD treatment. 223,224 The studies were relatively short, at 6, 12 and 24 weeks. Two of the studies evaluated the superiority of FP/SAL combination therapy compared with BUD.…”

“…Two of the studies evaluated the superiority of FP/SAL combination therapy compared with BUD. 223,225 Zhong and colleagues 225 assessed the efficacy and safety of the treatments in patients with asthma that was uncontrolled with low-dose ICS treatment. Jenkins 223 Two trials reported patients as having been previously treated with a daily dose of 500 µg BUD or BDP.…”

Improvement in asthma endpoints when aiming for total control: salmeterol/fluticasone propionate versus fluticasone propionate alone

“…Greater improvements were seen with salmeterol/fluticasone propionate versus fluticasone propionate alone and this finding is consistent with those of previous studies. [6][7][8] The differences seen between the treatment arms were clinically significant and the improvements seen in percentage of symptom-free days are of particular note. Overall, combination therapy provided an additional 66 symptom-free days per year when compared with fluticasone propionate alone, and in all strata, symptom-free days and rescue-free days were more probable in patients receiving combination therapy than in patients receiving fluticasone propionate alone.…”