Safety of regular formoterol or salmeterol in children with asthma

Long acting beta2-agonists (LABA) appear to be associated with more serious adverse events than placebo in children with asthma. Combination of corticosteroids to LABA appears to reduce adverse events.

The quality of evidence is downgraded by imprece results (wide confidence intervals).

Summary

A Cochrane review 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.

Clinical comments

Date of latest search: 2012-05-24

Ədəbiyyat

1. Cates CJ, Oleszczuk M, Stovold E et al. Safety of regular formoterol or salmeterol in children with asthma: an overview of Cochrane reviews. Cochrane Database Syst Rev 2012;10():CD010005.