The quality of evidence is downgraded by imprece results (wide confidence intervals).
A combination of LABA and corticosteroids is recommended over LABA alone for children whose asthma is not controlled by corticosteroids alone.
A Cochrane review [Abstract] 1 included 21 studies with a total of 7630 subjects. The children (from 4 to 17 years of age) were receiving long acting beta2-agonists formoterol or salmeterol alone or in combination with corticosteroid therapy.
There were more non-fatal serious adverse events in children taking long lasting beta2-agonists compared to those on placebo; for every 1000 children treated with formoterol or salmeterol over six months, 21 extra children suffered a non-fatal event in comparison with placebo. There was a smaller and non-significant increase in serious adverse events in children on formoterol or salmeterol and corticosteroids compared to corticosteroids alone: for every 1000 children treated with combination therapy over three months, three extra children suffered a serious adverse event in comparison with corticosteroids alone. On the other hand, combination therapy of long acting beta2-agonists and corticosteroids is likely to be less risky than beta2-agonists monotherapy alone. No difference was identified in the comparative safety of formoterol and salmeterol (based on 1 direct study and indirect evidence from the drug trials). Only one child died across all the trials, so impact on mortality could not be assessed.
| Outcome | Number of participants (trials) | Control:Placebo | Intervention:Formoterol monotherapy | Effect size (95% CI) |
| Serious adverse event (non fatal) | 1335(5) | 12/1000 | 30/1000 | OR 2.48(1.27 to 4.83) |
| Outcome | Number of participants (trials) | Control:Placebo | Intervention:Salmeterol monotherapy | Effect size (95% CI) |
| Serious adverse event (non fatal) | 1333(5) | 56/1000 | 72/1000 | OR 1.30(0.82 to 2.05) |
| Outcome | Number of participants (trials) | Control:Corticosteroids | Intervention:Formoterol combination therapy | Effect size (95% CI) |
| Serious adverse event (non fatal) | 2788(7) | 8/1000 | 14/1000 | OR 1.60(0.80 to 3.28) |
| Outcome | Number of participants (trials) | Control:Corticosteroids | Intervention:Salmeterol combination therapy | Effect size (95% CI) |
| Serious adverse event (non fatal) | 1862(5) | 5/1000 | 6/1000 | OR 1.20(0.37 to 2.91) |
| Outcome | Number of participants (trials) | Control:Salmeterol monotherapy | Intervention:Formoterol monotherapy | Effect size (95% CI) |
| Serious adverse event (non fatal) | 156(1) | 13/1000 | 12/1000 | OR 0.95(0.06 to 15.33) |
Date of latest search: 2012-05-24
Primary/Secondary Keywords