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Maintenance plus reliever budesonide/formoterol compared with a higher maintenance dose of budesonide/formoterol plus formoterol as reliever in asthma: an efficacy and cost-effectiveness study

Lundborg, M ; Wille, S ; Bjermer, Leif LU ; Tilling, B ; Lundgren, M ; Telg, G ; Ekstrom, T and Selroos, O (2006) In Current Medical Research and Opinion 22(5). p.809-821
Abstract
Objective: To evaluate efficacy and cost-effectiveness of budesonide/formoterol (Symbicort*) maintenance (one dose once or twice daily) plus additional doses as needed (Symbicort Maintenance And Reliever Therapy, SMART) compared with a higher fixed dose of budesonide/ formoterol with formoterol as needed in patients with persistent asthma. Study design and methods: 6-month, open, randomised study of 465 patients either not well controlled on an inhaled corticosteroid (ICS), or well controlled on a combination of ICS and a long-acting beta(2)-agonist (LABA). Treatments: budesonide/ formoterol 160/4.5 mu g, one inhalation, once or twice daily maintenance plus additional doses as- needed (1 x SMART or 2 x SMART), or budesonide/ formoterol... (More)
Objective: To evaluate efficacy and cost-effectiveness of budesonide/formoterol (Symbicort*) maintenance (one dose once or twice daily) plus additional doses as needed (Symbicort Maintenance And Reliever Therapy, SMART) compared with a higher fixed dose of budesonide/ formoterol with formoterol as needed in patients with persistent asthma. Study design and methods: 6-month, open, randomised study of 465 patients either not well controlled on an inhaled corticosteroid (ICS), or well controlled on a combination of ICS and a long-acting beta(2)-agonist (LABA). Treatments: budesonide/ formoterol 160/4.5 mu g, one inhalation, once or twice daily maintenance plus additional doses as- needed (1 x SMART or 2 x SMART), or budesonide/ formoterol 160/4.5 mu g two inhalations twice daily plus formoterol 4.5 mu g as needed (2 x 2 FIX + F). Children 6-11 years old used an 80/4.5 mu g dose strength. Primary variables of efficacy were the changes in the Asthma Control Questionnaire (ACQ(5)) and morning peak expiratory flow (PEF). Results: Mean age of patients 40 years (range 6-82 years); 53% female. No differences between the groups were found in ACQ(5) scores or asthma exacerbation rates. Morning PEF was higher in the 2 x 2 FIX + F group vs. the 1 x SMART and 2 x SMART groups ( differences 13L/min and 9 L/min, respectively; p < 0.002). The 1 x SMART group showed a significant decrease in asthma controlled days compared with the two other groups. No difference was seen between the 2 x SMART group and the 2 x 2 FIX + F group. Treatment costs were significantly lower in the SMART groups compared with the 2 x 2 FIX + F group. Conclusion: Compared with the 2 x 2 FIX + F treatment the use of budesonide/formoterol was 30-40% lower in the SMART groups while maintaining equal ACQ5 scores. Daily asthma control improved equally with 2 x SMART compared to 2 x 2 FIX + F with a reduction in asthma medication cost. The one dose once daily maintenance treatment (1 x SMART) resulted in a low level of treatment failure (exacerbations) but led to more days with symptoms. Therefore, a daily dose of two inhalations seems to be the lowest appropriate dose in patients with moderate persistent asthma. (Less)
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author
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Symbicort Maintenance and Reliever Therapy (SMART), reliever therapy, maintenance therapy, asthma, budesonide/formoterol
in
Current Medical Research and Opinion
volume
22
issue
5
pages
809 - 821
publisher
LibraPharm
external identifiers
  • pmid:16709303
  • wos:000238447700001
  • scopus:33745010924
ISSN
1473-4877
DOI
10.1185/030079906X100212
language
English
LU publication?
yes
id
481a140e-cf3e-4f54-bae5-a1ac2ddbf913 (old id 405650)
date added to LUP
2016-04-01 11:44:40
date last changed
2020-10-20 03:05:34
@article{481a140e-cf3e-4f54-bae5-a1ac2ddbf913,
  abstract     = {Objective: To evaluate efficacy and cost-effectiveness of budesonide/formoterol (Symbicort*) maintenance (one dose once or twice daily) plus additional doses as needed (Symbicort Maintenance And Reliever Therapy, SMART) compared with a higher fixed dose of budesonide/ formoterol with formoterol as needed in patients with persistent asthma. Study design and methods: 6-month, open, randomised study of 465 patients either not well controlled on an inhaled corticosteroid (ICS), or well controlled on a combination of ICS and a long-acting beta(2)-agonist (LABA). Treatments: budesonide/ formoterol 160/4.5 mu g, one inhalation, once or twice daily maintenance plus additional doses as- needed (1 x SMART or 2 x SMART), or budesonide/ formoterol 160/4.5 mu g two inhalations twice daily plus formoterol 4.5 mu g as needed (2 x 2 FIX + F). Children 6-11 years old used an 80/4.5 mu g dose strength. Primary variables of efficacy were the changes in the Asthma Control Questionnaire (ACQ(5)) and morning peak expiratory flow (PEF). Results: Mean age of patients 40 years (range 6-82 years); 53% female. No differences between the groups were found in ACQ(5) scores or asthma exacerbation rates. Morning PEF was higher in the 2 x 2 FIX + F group vs. the 1 x SMART and 2 x SMART groups ( differences 13L/min and 9 L/min, respectively; p &lt; 0.002). The 1 x SMART group showed a significant decrease in asthma controlled days compared with the two other groups. No difference was seen between the 2 x SMART group and the 2 x 2 FIX + F group. Treatment costs were significantly lower in the SMART groups compared with the 2 x 2 FIX + F group. Conclusion: Compared with the 2 x 2 FIX + F treatment the use of budesonide/formoterol was 30-40% lower in the SMART groups while maintaining equal ACQ5 scores. Daily asthma control improved equally with 2 x SMART compared to 2 x 2 FIX + F with a reduction in asthma medication cost. The one dose once daily maintenance treatment (1 x SMART) resulted in a low level of treatment failure (exacerbations) but led to more days with symptoms. Therefore, a daily dose of two inhalations seems to be the lowest appropriate dose in patients with moderate persistent asthma.},
  author       = {Lundborg, M and Wille, S and Bjermer, Leif and Tilling, B and Lundgren, M and Telg, G and Ekstrom, T and Selroos, O},
  issn         = {1473-4877},
  language     = {eng},
  number       = {5},
  pages        = {809--821},
  publisher    = {LibraPharm},
  series       = {Current Medical Research and Opinion},
  title        = {Maintenance plus reliever budesonide/formoterol compared with a higher maintenance dose of budesonide/formoterol plus formoterol as reliever in asthma: an efficacy and cost-effectiveness study},
  url          = {http://dx.doi.org/10.1185/030079906X100212},
  doi          = {10.1185/030079906X100212},
  volume       = {22},
  year         = {2006},
}