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

• Published in: Respiratory medicine Vol. 94; no. 7; pp. 715 - 723
• Main Authors: JENKINS, C., WOOLCOCK, A.J., SAARELAINEN, P., LUNDBÄCK, B., JAMES, M.H.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.07.2000; Elsevier
• Subjects: asthma; Biological and medical sciences; budesonide; DiskusTM; fluticasone propionate; Medical sciences; Pharmacology. Drug treatments; Respiratory system; salmeterol; budesonide; DiskusTM; asthma; salmeterol; fluticasone propionate; Human; Budesonide; Corticosteroid; Agonist; Respiratory disease; Bronchodilator; Treatment efficiency; Antiinflammatory agent; Salmeterol; β2-Adrenergic receptor; β-Adrenergic receptor agonist; Fluticasone; Antiasthma agent; Asthma; Chemotherapy; Treatment; Combined treatment; Obstructive pulmonary disease; Comparative study
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1053/rmed.2000.0875

Three hundred and fifty-three asthmatic patients who remained symptomatic despite treatment with budesonide 800–1200 μ g day−1(or equivalent) were randomized to a new combination therapy comprising salmeterol 50 μ g and fluticasone propionate 250 μ g (SeretideTM, AdvairTM, VianiTM50/250 μ g) twice daily or budesonide 800 μ g 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 45 l 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 (406vs . 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 μ g twice daily is superior to budesonide 800 μ g twice daily in the management of patients with moderate to severe asthma who are symptomatic on their existing dose of corticosteroid.