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Pediatrics. 2011 Nov;128(5):e1147-54. doi: 10.1542/peds.2010-1720. Epub 2011 Oct 24.

Age and risks of FDA-approved long-acting β₂-adrenergic receptor agonists.

Author information

  • 1Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD 20993, USA. ann.mcmahon@fda.hhs.gov

Abstract

OBJECTIVE:

To determine the risk, by age group, of serious asthma-related events with long-acting β(2)-adrenergic receptor agonists marketed in the United States for asthma.

METHODS:

The US Food and Drug Administration performed a meta-analysis of controlled clinical trials comparing the risk of LABA use with no LABA use for patients 4 to 11, 12 to 17, 18 to 64, and older than 64 years old. The effects of age on a composite of asthma-related deaths, intubations, and hospitalizations (asthma composite index) and the effects of concomitant inhaled corticosteroid (ICS) use were analyzed.

RESULTS:

One hundred ten trials with 60 954 patients were included in the meta-analysis. The composite event incidence difference for all ages was 6.3 events per 1000 patient-years (95% confidence interval [CI]: 2.2-10.3) for using LABAs compared with not using LABAs. The largest incidence difference was observed for the 4- to 11-year age group (30.4 events per 1000 patient-years [95% CI: 5.7-55.1]). Differences according to age were statistically significant (P = .020). Results for the subgroup of patients with concomitant ICS use (n = 36 210) were similar to the overall results; with assigned ICSs (n = 15 192), the incidence difference was 0.4 events per 1000 patient-years (95% CI: -3.8 to 4.6), and there was no statistically significant difference according to age group.

CONCLUSIONS:

The excess of serious asthma-related events attributable to LABAs was greatest among children. Additional data are needed to assess risks of LABA use for children with simultaneous ICS use.

PMID:
22025595
[PubMed - indexed for MEDLINE]
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