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

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Abstract
Objective: To study the effectiveness and safety of budesonide/formoterol (Symbicort<SU (R)</SU) Maintenance And Reliever Therapy (Symbicort SMART<SU (R)</SU, AstraZeneca, Sodertalje, 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 >= 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<SU (R)</SU 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<SU (R)</SU group (including as-needed use) vs. in the CBP group (749 mu g vs. 1059 mu g; 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 euro vs. 66.5 euro; 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.
Keywords
moderate, efficacy, combination, questionnaire, trial, exacerbations, Single-inhaler, budesonide, formoterol, cost-effectiveness, SINGLE INHALER, COST-EFFECTIVENESS, BUDESONIDE, FORMOTEROL, EXACERBATIONS, TRIAL, QUESTIONNAIRE, COMBINATION, EFFICACY, MODERATE

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Chicago
Louis, R, Guy Joos, A Michils, and G Vandenhoven. 2009. “A Comparison of Budesonide/formoterol Maintenance and Reliever Therapy Vs Conventional Best Practice in Asthma Management.” International Journal of Clinical Practice 63 (10): 1479–1488.
APA
Louis, R., Joos, G., Michils, A., & Vandenhoven, G. (2009). A comparison of budesonide/formoterol maintenance and reliever therapy vs conventional best practice in asthma management. INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, 63(10), 1479–1488.
Vancouver
1.
Louis R, Joos G, Michils A, Vandenhoven G. A comparison of budesonide/formoterol maintenance and reliever therapy vs conventional best practice in asthma management. INTERNATIONAL JOURNAL OF CLINICAL PRACTICE. 2009;63(10):1479–88.
MLA
Louis, R, Guy Joos, A Michils, et al. “A Comparison of Budesonide/formoterol Maintenance and Reliever Therapy Vs Conventional Best Practice in Asthma Management.” INTERNATIONAL JOURNAL OF CLINICAL PRACTICE 63.10 (2009): 1479–1488. Print.
@article{806546,
  abstract     = {Objective: To study the effectiveness and safety of budesonide/formoterol (Symbicort{\textlangle}SU (R){\textlangle}/SU) Maintenance And Reliever Therapy (Symbicort SMART{\textlangle}SU (R){\textlangle}/SU, AstraZeneca, Sodertalje, 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 {\textrangle}= 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{\textlangle}SU (R){\textlangle}/SU 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{\textlangle}SU (R){\textlangle}/SU group (including as-needed use) vs. in the CBP group (749 mu g vs. 1059 mu g; p {\textlangle} 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 euro vs. 66.5 euro; p {\textlangle} 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.},
  author       = {Louis, R and Joos, Guy and Michils, A and Vandenhoven, G},
  issn         = {1368-5031},
  journal      = {INTERNATIONAL JOURNAL OF CLINICAL PRACTICE},
  keyword      = {moderate,efficacy,combination,questionnaire,trial,exacerbations,Single-inhaler,budesonide,formoterol,cost-effectiveness,SINGLE INHALER,COST-EFFECTIVENESS,BUDESONIDE,FORMOTEROL,EXACERBATIONS,TRIAL,QUESTIONNAIRE,COMBINATION,EFFICACY,MODERATE},
  language     = {eng},
  number       = {10},
  pages        = {1479--1488},
  title        = {A comparison of budesonide/formoterol maintenance and reliever therapy vs conventional best practice in asthma management},
  url          = {http://dx.doi.org/10.1111/j.1742-1241.2009.02185.x},
  volume       = {63},
  year         = {2009},
}

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