EVIDENCE-BASED CHILD HEALTH: A COCHRANE REVIEW JOURNAL Evid.-Based Child Health 9: 751–752 (2014) Published online in Wiley Online Library (http://www.evidence-basedchildhealth.com). DOI: 10.1002/ebch.1982

Eco-Paediatrics ...reducing waste in child health one intervention at a time.

Formoterol or salmeterol for asthma—should they be used as monotherapy? Eco-paediatrics is an occasional feature in Evidence-Based Child Health: A Cochrane Review Journal. Our goal is to contribute to the worldwide discussion on reducing waste in health care. In each instalment, we will select a recent Cochrane review highlighting a practice, still in use, which the available evidence tells us should be discontinued.

Evidence-Based Child Health: a Cochrane Review Journal is now indexed by MEDLINE (http://www.ncbi. nlm.nih.gov/pubmed) and Scopus (http://www.scopus.com)

Excerpts from: Cates CJ, Stovold E, Wieland S, Oleszczuk M, Thomson D, Becker L 2012, The Cochrane Library and safety of regular long-acting beta2-agonists in children with asthma: an overview of reviews. Evidence-Based Child Health, 7: 1798–1806. DOI: 10.1002/ebch.1889 For the full overview, see The Cochrane Library version: Excerpts from: Cates CJ, Oleszczuk M, Stovold E, Wieland LS. Safety of regular formoterol or salmeterol in children with asthma: an overview of Cochrane reviews. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: CD 010005. DOI: 10.1002/14651858.CD010005.pub2.

Asthma Asthma is a common condition, often triggered by an irritant that causes the airway muscles to tighten and narrow so that the lining of the airways become inflamed and begins to swell. The symptoms include wheezing, coughing and difficulty in breathing.

Formoterol or salmeterol People with asthma are generally advised to take inhaled corticosteroids (ICS) to combat the underlying inflammation in their lungs, with additional medication if it is still not controlled. Inhaled beta-2 agonists (such as salbutamol) can relieve the wheezing and breathlessness by relaxing the airway muscles, and be used as intermittent first-step treatment for children with asthma. Patients who require further treatment can add ICS. Adding a long-acting beta-agonist (LABA), such as formoterol or salmeterol, to an ICS is the current recommended step for people whose asthma is not controlled with regular ICS alone. Copyright © 2014 John Wiley & Sons, Ltd.

What should we do in practice? Monotherapy with regular formoterol or salmeterol is no longer advocated in clinical guidelines. If separate inhalers are used to deliver LABA and ICS, there is the risk of children defaulting to their ICS treatment while continuing to take LABA so combination inhalers should be used to deliver LABA and ICS in a single inhaler for children with asthma. Regular combination therapy is likely to be safer than monotherapy in children with asthma, but we cannot say that combination therapy is risk free. There are probably an additional three children per 1000 over 3 months who suffer a nonfatal serious adverse event on combination therapy, in comparison to ICS. We do not know if regular combination therapy with formoterol or salmeterol alters the risk of dying from asthma. The relative safety of formoterol and salmeterol in children also remains uncertain.

What do the guidelines suggest? National Institute for Health and Care Excellence (1)

2.5 The aim of asthma management is to control the symptoms, prevent exacerbations andÐin school-aged childrenÐto achieve the best possible lung function. Pharmacological management includes drugs such as inhaled corticosteroids (ICSs) and short- and long-acting beta-2 agonists (SABAs/LABAs). The latter should be used only in combination with an ICS. 2.7 Mild intermittent asthma (step 1) is treated with inhaled SABAs, as required. The introduction of regular preventer therapy with ICSs (step 2) should be considered when a child has had exacerbations of asthma in the previous 2 years, is using inhaled SABAs three times a week or more, is symptomatic three times a

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week or more, or is waking at night once a week because of asthma. In children who cannot take an ICS, a leukotriene receptor antagonist is recommended. 2.8 There is no precise ICS dose threshold for moving to step 3 (add-on therapy), in which a third drug is introduced. However, in children aged 5–12 years, the guidelines recommend a trial of add-on therapy before increasing the daily dose of ICS above the equivalent of 400 μg of beclomethasone diproprionate. The first choice for add-on therapy in children older than 5 years is the addition of a LABA. In children aged 2–5 years, a leukotriene receptor antagonist should be considered. For children younger than 2 years, consideration should be given to referral to a respiratory paediatrician.

risk of side effects with LABAs and the efficacy of ICS as first line therapy, clinicians should not use LABAs as isolated therapy for chronic asthma symptoms. Although there is some thought that an increased risk of severe exacerbation remains even with combination therapy with ICS and LABA together, guidelines do continue to recommend this as a therapeutic option for more severe persistent asthma in older children. Ongoing surveillance studies will hopefully clarify this question of whether combination therapy has any associated risks. The authors of this overview emphasize that LABAs should only be available in combination therapy as a single administration product with ICS. This concept is important because families do get confused about different inhaler types and medication indications and the risk for monotherapy with LABA to occur even if a separate ICS was also prescribed is a real concern.

Evidence-Based Child Health, Editorial Office* *Correspondence to: Evidence-Based Child Health Canadian editorial office. E-mail: [email protected]

Declaration of interest No conflict of interest to declare.

Keywords: asthma, beta agonist, adrenergic, aerosol drug therapy

Mike Steiner, EBCH Editor*

Commentary by M. Steiner Asthma is a high prevalence disease with high morbidity in paediatric patients. In part because of the complex asthma pathophysiology, there are many effective treatment options for asthma control including ICS, leukotriene receptor antagonists, LABAs, and even biologic agents such as omalizumab have a role in certain asthma subtypes. Despite those therapeutic options, both the British National Institute for Health and Care Excellence guidelines (1) and the National Heart Lung and Blood Institute guidelines (2) now recommend a relatively simple to follow, stepwise approach to medication escalation that starts with short-acting bronchodilators if children have only occasional symptoms, and then ICS as the first medication for almost all children with persistent symptoms, and adds other therapies to ICS when control is inadequate. Due to increased

General Pediatrics and Adolescent Medicine, University of North Carolina, NC Children’s Hospital, Chapel Hill, NC, USA *Correspondence to: Mike Steiner, General Pediatrics and Adolescent Medicine, University of North Carolina, NC Children’s Hospital, Chapel Hill, NC, USA. E-mail: [email protected] Keywords: asthma, therapy, beta agonist, adrenergic

References 1. Excellence NIfHaC. Inhaled corticosteroids for the treatment of chronic asthma in children under the age of 12 years. NICE technology appraisal guidance [WWW document]. Available at: http://guidance.nice.org.uk/TA131/Guidance/pdf/English [accessed on 18 October 2013]. 2. National Heart, Lung, and Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Bethesda, Maryland: National Institutes of Health; 2007. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf [accessed on 18 October 2013].

If you would like to make a comment on the above article, you are invited to submit a letter to the Editor by email ([email protected]). Selected letters may be edited and published in future issues of the journal.

Copyright © 2014 John Wiley & Sons, Ltd.

Evid.-Based Child Health 9: 751–752 (2014) DOI: 10.1002/ebch.1982

Formoterol or salmeterol for asthma--should they be used as monotherapy?

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