Azithromycin Treatment Improved Pulmonary Function and Nutritional Status in Pat

[Guest guest]

Azithromycin Treatment Improved Pulmonary Function and Nutritional

Status in Patients With Cystic Fibrosis

A DGReview of : " Azithromycin in Patients With Cystic Fibrosis

Chronically Infected With Pseudomonas aeruginosa: A Randomized

Controlled Trial "

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. " Azithromycin in Patients With Cystic

Fibrosis Chronically Infected With Pseudomonas aeruginosa: A

Randomized Controlled Trial "