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Azithromycin Treatment Improved Pulmonary Function and Nutritional Status in

Patients With Cystic Fibrosis

A DGReview of :<A

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B46BEC848B66B9E85256C6800075D15 & c= & count=10 " > " Azithromycin in Patients With

Cystic Fibrosis Chronically

Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial " </A>

Journal of the American Medical Association (JAMA)

10/02/2003

By Joene Hendry

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 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 daily

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. <A

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B46BEC848B66B9E85256C6800075D15 & c= & count=10 " > " Azithromycin in Patients With

Cystic Fibrosis

Chronically Infected With Pseudomonas aeruginosa</A>