New Review Supports Use Of Formoterol In Children And Adolescents With Asthma

Main Category: Respiratory / Asthma
Also Included In: Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 07 Oct 2008 - 4:00 PST

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A new review of the long acting beta2-agonist (LABA) formoterol presented today at the European Respiratory Society (ERS) congress, shows that formoterol use in children and adolescents (4-17 years) with asthma, who are predominantly prescribed concomitant inhaled corticosteroids (ICS), is not associated with any increased risk of asthma-related hospitalisations.[i]

Today's review assessed the frequency of asthma-related deaths and hospitalisations following formoterol use in children and adolescents, compared with non-LABA treatment, in all AstraZeneca-sponsored, randomised, controlled, parallel-group trials (≥1 month) where formoterol was used as maintenance and/or reliever therapy. 12,083 patients aged 4-17 years from 53 trials were assessed in the analysis.

The results of the review show that there was no difference in the frequency of patients with asthma-related hospitalisations in formoterol-treated compared to non-LABA-treated patients, either in children (1.1% [38/3316] vs 1.1% [23/2165]) or in adolescents (0.5% [23/4651] vs 0.8% [16/1951]). The number of asthma-related deaths (one death among 7,967 formoterol-treated patients, and no deaths among the 4,116 non-LABA-treated patients) was too low to allow any inter-group comparison. 83 percent of patients in this review were using an ICS as concomitant medication whilst participating in the studies analysed.

"This review adds to the ongoing discussion around LABA safety with particular reference to formoterol. It is clear that in this analysis, the use of formoterol in conjunction with ICS, as indicated and recommended in guidelines from a number of major professional associations, is not associated with an increased frequency of asthma related hospitalisations," commented Professor John Price, King's College Hospital, London.

These data add to a major review of almost 80,000 patients from 117 trials, recently published online by Sears et al in the European Respiratory Journal, [ii] which shows that the use of formoterol was associated with a significant reduction in asthma-related non-fatal serious adverse events (SAEs) versus non-LABA treatment, in patients of all ages in the whole dataset (RR 0.68, 95% CI 0.57-0.81) or in addition to those prescribed ICS as baseline (RR 0.63, 95% CI 0.52-0.76).

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

References

[i] J Price. Safety of formoterol in children and adolescents: Experience from asthma clinical trials. Presented at the European Respiratory Society annual congress, 7 October 2008; abstract number 3053

[ii] M.R.Sears et al; Long-acting beta agonists. A review of formoterol safety data from asthma clinical trials. Eur Resp J Published online Sept 3, 2008 as doi:10.1183/0903 1936.00145006

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