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Meta-Analysis
. 2010 Sep 8;2010(9):CD008418.
doi: 10.1002/14651858.CD008418.pub2.

Formoterol versus short-acting beta-agonists as relief medication for adults and children with asthma

Emma J Welsh  1 , Christopher J Cates
Affiliations
Meta-Analysis

Formoterol versus short-acting beta-agonists as relief medication for adults and children with asthma

Emma J Welsh et al. Cochrane Database Syst Rev. .

Abstract

Background: Formoterol is a long-acting beta(2)-agonist but because it has a fast onset of action it can also be used as a relief medication.

Objectives: To asses the efficacy and safety of formoterol as reliever therapy in comparison to short-acting beta(2)-agonists in adults and children with asthma.

Search strategy: We searched the Cochrane Airways Group Specialised Register and websites of clinical trial registers (for unpublished trial data), and we checked the Food and Drug Administration (FDA) submissions in relation to formoterol. The date of the most recent search was February 2010.

Selection criteria: Randomised, parallel-arm trials of at least 12 weeks duration in patients of any age and severity of asthma. Studies randomised patients to any dose of as-needed formoterol versus short-acting beta(2)-agonist. Concomitant use of inhaled corticosteroids or other maintenance medication was allowed, as long as this was not part of the randomised treatment regimen.

Data collection and analysis: Two authors independently selected trials for inclusion in the review. Outcome data were extracted by one author and checked by the second author. We sought unpublished data on primary outcomes.

Main results: This review includes eight studies conducted in 22,604 participants (mostly adults). Six studies compared formoterol as-needed to terbutaline whilst two studies compared formoterol with salbutamol as-needed. Background maintenance therapy varied across the trials. Asthma exacerbations and serious adverse events showed a direction of treatment effect favouring formoterol, of which one outcome reached statistical significance (exacerbations requiring a course of oral corticosteroids). In patients on short-acting beta(2)-agonists, 117 people out of 1000 had exacerbations requiring oral corticosteroids over 30 weeks, compared to 101 (95% CI 93 to 108) out of 1000 for patients on formoterol as-needed. In patients on maintenance inhaled corticosteroids there were also significantly fewer exacerbations requiring a course of oral corticosteroids on formoterol as-needed (Peto OR 0.75; 95% CI 0.62 to 0.91). There was one death per 1000 people on formoterol or on short-acting beta(2)-agonists.

Authors' conclusions: In adults, formoterol was similar to short-acting beta(2)-agonists when used as a reliever, and showed a reduction in the number of exacerbations requiring a course of oral corticosteroids. Clinicians should weigh the relatively modest benefits of formoterol as-needed against the benefits of single inhaler therapy and the potential danger of long-term use of long-acting beta(2)-agonists in some patients. We did not find evidence to recommend changes to guidelines that suggest that long-acting beta(2)-agonists should be given only to patients already taking inhaled corticosteroids.There was insufficient information reported from children in the included trials to come to any conclusion on the safety or efficacy of formoterol as relief medication for children with asthma.

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Conflict of interest statement

None known.

Figures

1
1
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
2
2
Forest plot of comparison: 1 Formoterol versus short‐acting beta2‐agonist, outcome: 1.1 Patients with an exacerbation requiring hospitalisation.
3
3
Forest plot of comparison: 1 Formoterol versus short‐acting beta2‐agonist, outcome: 1.2 Patients with an exacerbation requiring a course of oral corticosteroids.
4
4
In patients on short‐acting beta2‐agonists, 117 people out of 1000 had exacerbations requiring oral corticosteroids over 30 weeks, compared to 101 (95% CI 93 to 108) out of 1000 for patients on formoterol as‐needed.
5
5
Forest plot of comparison: 2 Formoterol versus short‐acting beta2‐agonist (background ICS use), outcome: 2.1 Patients with an exacerbation requiring a course of oral corticosteroids.
6
6
Forest plot of comparison: 1 Formoterol versus short‐acting beta2‐agonist, outcome: 1.3 Fatal serious adverse events (all‐cause).
7
7
Forest plot of comparison: 1 Formoterol versus short‐acting beta2‐agonist, outcome: 1.4 Patients with a serious adverse event (all‐cause).
8
8
Forest plot of comparison: 2 Formoterol versus short‐acting beta2‐agonist (background ICS use), outcome: 2.2 Patients with a serious adverse event (all‐cause).
9
9
Forest plot of comparison: 1 Formoterol versus short‐acting beta2‐agonist, outcome: 1.5 Patients with a serious adverse event (asthma‐related).
1.1
1.1. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 1 Patients with an exacerbation requiring hospitalisation.
1.2
1.2. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 2 Patients with an exacerbation requiring a course of oral corticosteroids.
1.3
1.3. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 3 Fatal serious adverse events (all‐cause).
1.4
1.4. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 4 Patients with a serious adverse event (all‐cause).
1.5
1.5. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 5 Patients with a serious adverse event (asthma‐related).
1.6
1.6. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 6 Peak expiratory flow (morning).
1.7
1.7. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 7 Peak expiratory flow (evening).
1.8
1.8. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 8 Fixed expiratory flow in one second (FEV1) litres.
1.9
1.9. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 9 Change in FEV1 % predicted.
1.10
1.10. Analysis
Comparison 1 Formoterol versus short‐acting beta2‐agonist, Outcome 10 Withdrawals (any reason).
2.1
2.1. Analysis
Comparison 2 Formoterol versus short‐acting beta2‐agonist (background ICS use), Outcome 1 Patients with an exacerbation requiring a course of oral corticosteroids.
2.2
2.2. Analysis
Comparison 2 Formoterol versus short‐acting beta2‐agonist (background ICS use), Outcome 2 Patients with a serious adverse event (all‐cause).
3.1
3.1. Analysis
Comparison 3 Formoterol versus short‐acting beta2‐agonists (background LABA use), Outcome 1 Patients with a serious adverse event (all‐cause).
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Update of

References

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References to studies excluded from this review

Bisgaard 2005 {published data only}
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