A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management.

• Abstract: OBJECTIVE: To study the effectiveness and safety of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (Symbicort SMART, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma. DESIGN: Open-label randomised controlled parallel group trial, 6-month treatment. PARTICIPANTS: A total of 908 patients > or = 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting beta(2)-agonist. MAIN OUTCOME MEASURES: Time to first severe asthma exacerbation and number of severe asthma exacerbations. RESULTS: No difference between groups was seen in time to first severe exacerbation (p = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART group (including as-needed use) vs. in the CBP group (749 microg vs. 1059 microg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 euros vs. 66.5 euros; p < 0.0001). CONCLUSIONS: In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.
• Authors: R Louis, G Joos, A Michils, G Vandenhoven (Affiliation: Pneumology, CHU Sart Tilman, Liège, Belgium. r.louis at chu.ulg.ac.be)
• Journal: International journal of clinical practice (Int J Clin Pract) Vol. 63 Issue 10 Pg. 1479-88 (Oct 2009) ISSN: 1742-1241 [Electronic] England
• PMID: 19769705 (Publication Type: Journal Article)