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Azithromycin Treatment Improved Pulmonary Function and Nutritional Status in Patients With Cystic Fibrosis

Patients with cystic fibrosis (CF) who were infected with Pseudomonas aeruginosa showed improved pulmonary function and nutritional status, and decreased rates of pulmonary exacerbation after 24 weeks of azithromycin therapy compared with placebo.

"Care providers of patients with CF should consider this therapy for patients with CF aged 6 years or older and chronically infected with P aeruginosa," writes Lisa Saiman, MD, MPH, Columbia University College of Physicians and Surgeons, New York, United States and colleagues. They randomised 185 CF patients infected with P aeruginosa for 1 year or longer and with a forced expiratory volume in 1 second (FEV₁) of 30% or more to 168 days of oral azithromycin or placebo. The patients were all at least 6 years old (mean age approximately 20 years) and were treated at 23 CF care centers in the United States.

The 87 patients randomised to azithromycin received oral doses 3-times per week at 250 mg if they weighed <40 kg and at 500 mg if they weighed 40 kg or more, while the placebo group received identically packaged tablets.

The investigators found that the mean relative change from baseline in FEV₁% predicted revealed a 4.4% improvement in the azithromycin group compared with a 1.8% decline in the placebo group. The FEV₁% improvement in the azithromycin group was noted at day 28 and sustained throughout active treatment, but declined nearly to baseline 4 weeks after azithromycin treatment stopped.

Patients treated with azithromycin gained an average of 0.7 kg more and had less risk of a disease exacerbation (hazard ratio 0.65) than those receiving placebo. While the microbiologic profiles of the groups were similar at baseline by day 168 fewer patients (10%) in the azithromycin group had newly detected methicillin-susceptible Staphylococcus aureus. S. aureus was eradicated from 18% of the azithromycin treated patients compared with 12% of the placebo patients. The emergence or eradication of multidrug-resistant strains of P aeruginosa or other potential pathogens was similar between groups.

Adverse events including nausea, diarrhoea, and wheezing occurred, respectively, in 17%, 15%, and 13% more of the azithromycin group than in the placebo group. Most of the adverse events were of a mild or moderate intensity and no significant differences in laboratory abnormalities were reported between the treatment and placebo groups.

The authors note that recombinant human dornase alfa inhalation solution and tobramycin solution for inhalation were widely used by participants during this study indicating "that participants had clinical benefits when azithromycin was added to other therapies proven to be effective in patients with CF."

JAMA 2003;290:13:1749-1756. "Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial"

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