title: Inhaled aztreonam lysine for cystic fibrosis pulmonary disease-related outcomes.
abstract: OBJECTIVE
  To evaluate the pharmacology, clinical efficacy, and safety of aztreonam lysine for inhalation (AZLI) for cystic fibrosis (CF)-related signs and symptoms of pulmonary disease.
  
  
  METHODS
  Literature was searched in MEDLINE through PubMed and cross-referenced with EMBASE (1980-June 2012). The key search terms used were aztreonam lysine, nebulized, inhaled, and cystic fibrosis. Bibliographies of selected articles were used to identify additional references. Ongoing trials were identified through a review of Web site trial registries.
  
  
  METHODS
  Articles were limited to those written in English about studies conducted in humans. Studies included in this review examined both adult and pediatric patients with CF.
  
  
  RESULTS
  Aztreonam lysine is an inhaled monocyclic β-lactam antibiotic approved for use in the CF population. Four completed clinical trials with peer-reviewed published data were reviewed to assess the efficacy and safety of single-course AZLI; a fifth trial assessed the safety and efficacy of repeat courses of AZLI. None of these trials compared AZLI in a head-to-head manner with tobramycin for inhalation. In patients with moderate to severe pulmonary disease, AZLI administration improved forced expiratory volume in 1 second measurements, decreased sputum bacterial Pseudomonas aeruginosa density, and improved symptoms. Adverse effects in clinical trials were generally mild and similar to those with placebo.
  
  
  CONCLUSIONS
  AZLI is safe and effective for management of pulmonary-related symptoms in patients with CF who are colonized with P. aeruginosa and have moderate to severe pulmonary disease. Additional trial data comparing AZLI with tobramycin are warranted to further establish the place of AZLI in therapy.
authors: Department of Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences-Worcester/Manchester, USA.
authors: Kimberly A
authors: KA
authors: Pesaturo
authors: Evan R
authors: ER
authors: Horton
authors: Paul
authors: P
authors: Belliveau
mesh_terms: D000280:Administration, Inhalation; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001398:Aztreonam / Q000008:administration & dosage* / Q000493:pharmacokinetics; D003550:Cystic Fibrosis / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D006801:Humans; D011552:Pseudomonas Infections / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D011550:Pseudomonas aeruginosa
chemical_list: D000900:Anti-Bacterial Agents; D001398:Aztreonam