Date of Award

2014

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department Chair

John Cavenagh, PhD, PA-C

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine whether or not aztreonam lysine for inhalation is effective in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa airway infection.

STUDY DESIGN: Review of three English language primary randomized controlled trials published in 2008, 2009, and 2011.

DATA SOURCES: Three randomized, double-blind, placebo-controlled studies using Cochrane and Pubmed databases.

OUTCOMES MEASURED: Patient oriented outcomes measured included change in respiratory symptoms measured by the Cystic Fibrosis Questionnaire-Revised and need for additional anti-pseudomonal antibiotics indicative of pulmonary exacerbation.

RESULTS: In both cystic fibrosis (CF) patients who have been treated with standard long term therapy and those who have not, 28 day therapy with aztreonam lysine for inhalation (AZLI) was shown to be effective in the treatment of chronic Pseudomonas aeruginosa airway infection. AZLI treatment showed statistical significance in the improvement of patient reported respiratory symptoms compared to placebo. Twice per day versus three times per day dosing did not show a significant impact on outcome. In CF patients with mild respiratory dysfunction, determined by a FEV1 of > 75%, AZLI treatment did not significantly prevent need for additional anti-pseudomonal antibiotics during the course of the study.

CONCLUSION: These studies determined that AZLI is more effective at reducing respiratory symptoms in CF patients with chronic P. aeruginosa airway infection than placebo. AZLI therapy does not significantly decrease the number of severe pulmonary exacerbations that would require further anti-pseudomonal antibiotics. Twice or three times per day dosing does not significantly affect the outcomes.

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