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Azithromycin Promising In Cystic Fibrosis Treatment
Lancet
09/26/2002
By Harvey McConnell
The macrolide antibiotic azithromycin can offer some benefit to people with cystic fibrosis who do not respond to conventional treatment.
Since azithromycin has anti-inflammatory properties potentially beneficial in cystic fibrosis, and open pilot studies indicate a clinical benefit, a formal trial was undertaken by Dr Mark Rosenthal and colleagues at the Royal Brompton Hospital, London, England.
Forty one children with cystic fibrosis between the ages of eight and 18 years were enrolled in a 15-month randomised double-blind, placebo-controlled crossover trial. They had a median forced expiratory volume in 1 s (FEV1 ) of 61 percent, with a range of 33 to 80 percent.
The children received either azithromycin (bodyweight 40 kg: 250 mg daily, >40 kg: 500 mg daily) or placebo for six months. After two months of washout, the treatments were crossed over.
The clinicians point out that as 95 percent of patients ultimately die of respiratory failure, a major aim is to treat endobronchial infection and inflammation. A narrow range of organisms, including Staphylococcus aureus and mucoid Pseudomonas aeruginosa, cause infections, and P aeruginosa is almost exclusively seen in patients with cystic fibrosis. Whether inflammation precedes infection or is exaggerated in response to it is uncertain.
Clinicians found in the trial that children given azithromycin had a modest improvement in FEV1 of 5.4 percent. However, there was wide variation, with 13 children improving and five children deteriorating by 13 percent. Forced vital capacity and mid-expiratory flow did not significantly change overall.
There was no difference in quality-of-life assessment between azithromycin and placebo groups. The antibiotic was well tolerated with few reported side effects.
Dr Rosenthal and colleagues conclude: "A four to six month trial of azithromycin is safe, comparatively inexpensive, and could greatly benefit the lung function of patients who do not respond adequately to conventional treatment for cystic fibrosis. The mechanism of benefit remains unknown."
Lancet 2002; 360: 978-84.
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