Children and adolescents with cystic fibrosis (CF) who received the antibiotic azithromycin did not experience improved lung function, compared to patients who received placebo, according to a new study.
There has been increasing evidence over the past decade that azithromycin benefits individuals with CF. “Azithromycin is recommended as therapy for CF patients with chronic Pseudomonas aeruginosa infection, but there has not been sufficient evidence to support the benefit of azithromycin in other patients with CF,” say the researchers.
They conducted a randomised, placebo-controlled trial involving children with CF uninfected with P aeruginosa to determine if azithromycin would improve lung function or reduce pulmonary exacerbations. Of the 324 participants screened, 260 met study criteria, were randomised and received either the study drug (n = 131) or placebo (n = 129). The average age was 10.7 years.
The researchers found that treatment with azithromycin for 24 weeks, compared with placebo, did not result in improved pulmonary function, as measured by the change in forced expiratory volume in one second. However, analyses of exploratory end points demonstrated that when compared with the placebo group, the azithromycin group had a 50 per cent reduction in pulmonary exacerbations, 27 per cent reduction in the initiation of new oral antibiotics (other than azithromycin), 1.3 lbs weight gain, and 0.34-unit increase in body mass index. There were no differences in treatment groups in the use of intravenous or inhaled antibiotics or hospitalisations.
The azithromycin group had less cough and less productive cough, compared with placebo participants.
JAMA 2010;303:1707-1715
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