Steinkamp G, Schmitt-Grohe S, Döring G, Staab D, Pfründer D, Beck G, Schubert R, Zielen S
Once-weekly azithromycin in cystic fibrosis with chronic Pseudomonas aeruginosa infection. [JOURNAL ARTICLE]
Respir Med 2008 Aug 11.
BACKGROUND: Data on the effects of long-term treatment with azithromycin (AZM) on inflammatory markers in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa are scarce. So far there is no pharmacokinetic and clinical data on once-weekly dosage of AZM in CF patients.
METHODS: In a randomised double-blind, placebo-controlled trial, patients received AZM or placebo 1 per week for 8 weeks (AZM dosage - 20-29kg: 500mg, 30-39kg: 750mg, 40-49kg: 1000mg and >/=50kg: 1250mg) after a course of intravenous antipseudomonal antibiotics. Pulmonary function tests, the serum markers LPS-binding protein (LBP), interleukin-8 (IL-8), CRP, P. aeruginosa alginate in sputum samples and quality of life scores were evaluated.
RESULTS: Thirty-eight patients (21 AZM/17 placebo) (mean age: 23.7 years; mean FEV(1): 62% of predicted) were recruited. After treatment (mean dose of 21.2mg/kg body weight once a week) pulmonary function declined in both groups compared to baseline (i.e. after cessation of IV antibiotics). The AZM group was significantly better for mean changes in serum CRP (AZM: +0.9mg/l, placebo: +21.6mg/l, p=0.019), lipopolysaccharide binding protein in serum, LBP (AZM: +0.9mug/ml, placebo: +7.0mug/ml, p=0.015), serum interleukin-8 (AZM: -3.1pg/ml, placebo: +2.9pg/ml, p=0.001) and alginate in sputum (AZM: +85mug/ml, placebo: +353mug/ml, p=0.048). Quality of life was significantly better after AZM and there was no increase in treatment-related adverse events.
CONCLUSION: Once-weekly azithromycin ameliorated inflammatory reactions and improved quality of life. A decline of pulmonary function after cessation of IV antibiotics could not be prevented.
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