Upload
baker-avila
View
23
Download
2
Tags:
Embed Size (px)
DESCRIPTION
The Effect Of Chronic Macrolide Therapy In Cystic Fibrosis Individuals Infected With Pseudomonas Aeruginosa. Natalie E. West, MD Postdoctoral Fellow Pulmonary and Critical Care Medicine July 23, 2010. Pulmonary infections are the main complication in Cystic Fibrosis. - PowerPoint PPT Presentation
Citation preview
The Effect Of Chronic Macrolide Therapy In Cystic Fibrosis Individuals
Infected With Pseudomonas Aeruginosa
Natalie E. West, MDPostdoctoral Fellow
Pulmonary and Critical Care MedicineJuly 23, 2010
Pulmonary infections are the main complication in Cystic Fibrosis
• Cystic Fibrosis (CF) is characterized by– chronic pulmonary infection – intermittent acute pulmonary exacerbations
• Most CF exacerbations:– Identified by increased symptoms & decreased
lung function (FEV1)
• Severe exacerbations require hospitalization and IV antibiotics
Acute pulmonary exacerbations decrease lung function in Cystic Fibrosis
CF Foundation Registry Report 2007
Azithromycin therapy has been shown to be beneficial in Pseudomonas treatment
• Design: Randomized, placebo-controlled, multicenter trial
• Participants: -CF individuals with P. aeruginosa-Age >6, Weight >25kg
• Exposure Azithromycin M/W/F• Primary Outcome Change in FEV1
• Results Azithromycin compared to control:Increase in FEV1 by 6.2% f (p=0.009)
Decreased exacerbations (p=0.03)0.7kg weight gain (p=0.02)
Saiman, L. JAMA. 2003; 290 (13):1749-56.
Large scale long term follow-up studies are needed
CF Foundation Registry Report 2007
Rate of Macrolide use per CF center
Our study: Does chronic macrolide therapy improve outcomes?
• HypothesisChronic macrolide therapy in CF patients with P.
aeruginosa results in decreased rates of pulmonary exacerbations requiring hospitalization, compared to those not treated
• Specific AimTo evaluate the long term effects of chronic
macrolide use in individuals with CF and P. aeruginosa infection, by looking at rates of pulmonary exacerbations requiring hospitalization
Long term study using the CF Registry• Design: Longitudinal, 3 year study using
the CF Foundation registry
• Participants: -CF individuals with P. aeruginosa-Age >6, Weight >25kg
• Exposure Macrolide use• Exposure Assessment Patient report
• Primary Outcome Exacerbations → hospitalizations• Outcome Assessment Chart Review
Statistical Analysis
• Multiple Poisson regression for repeated measures
• Adjusted for:– FEV1
– Inhaled Tobramycin (TOBI), pulmozyme , hypertonic saline
– methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia.
• Incidence rate ratio (IE/IO) calculated
Study population similar to general CF population
Variable
Age (± SD) 22.4 ± 10.4 years
Gender (% female) 47.2
Mean FEV1 % predicted (± SD) 72.3 ± 24.3
Inhaled Tobramycin (TOBI) (%) 79.6
Pulmozyme (%) 85.0
Hypertonic Saline (%) 57.4
MRSA (%) 31.0
Burkholderia cepaciae (%) 4.6
Macrolide therapy led to a decreased exacerbation rate
IRR SE P-value 95% CI
Macrolide therapy 0.85 0.07 0.043 0.73-0.99
FEV1 0.71 0.03 0.000 0.66-0.76
Tobramycin (TOBI) 1.20 0.71 0.002 1.07-1.35
Pulmozyme 1.14 0.09 0.080 0.98-1.32
Hypertonic Saline 1.23 0.07 0.000 1.11-1.37
Methicillin-Resistant Staphylococcus Aureus (MRSA)
1.32 0.08 0.000 1.16-1.49
Burkholderia cepacia 1.43 0.21 0.01 1.08-1.91
Strengths and Limitations• Strengths– Long term longitudinal
data– Aligns RCT and current
guidelines
• Limitations– Data collected at
individual centers, may increase risk of misclassification bias
Conclusion• We have shown that macrolide therapy
improves outcomes in individuals with CF and P.aeruginosa
• We recommend that macrolide therapy should be implemented widely in this population
Significance
• Large scale, long term study• Potential for improved patient
adherence• Potential for improved survival