Inhaled aztreonam lysine for cystic fibrosis pulmonary disease-related outcomes;Aztreonam lisina inhalada y los resultados en la enfermedad pulmonar relacionada con fibrosis quística

Annals of Pharmacotherapy

Volumn 46, Issue 7-8, 2012, Pages 1076-1085

  Pesaturo, Kimberly A ^a   Horton, Evan R ^a   Belliveau, Paul ^a  

^a MASSACHUSETTS COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

Author keywords

Aztreonam lysine; Cayston; Cystic fibrosis; Inhaled; Pseudomonas aeruginosa; Pulmonary

Indexed keywords

AZTREONAM LYSINE; PLACEBO; TOBRAMYCIN;

ARTICLE; CLINICAL TRIAL; COUGHING; CYSTIC FIBROSIS; DISEASE SEVERITY; DOSAGE SCHEDULE COMPARISON; DRUG COST; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG LABELING; DRUG SAFETY; DYSPNEA; FEVER; FORCED EXPIRATORY VOLUME; HEADACHE; HEMOPTYSIS; HUMAN; LUNG DISEASE; NOSE CONGESTION; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; RHINORRHEA; SPUTUM ANALYSIS; THORAX PAIN; TREATMENT DURATION; TREATMENT OUTCOME; WHEEZING;

EID: 84864748608     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1Q653     Document Type: Article

References (37)

1. Conway SP. Nebulized antibiotic therapy: the evidence. Chron Respir Dis 2005;2:35-41.
2. Le J, Dodds Ashley E, Neuhauser MM, et al. Consensus summary of aerosolized antimicrobial agents: application of guideline criteria. Pharmacotherapy 2010;30:562-584.
3. Ryan G, Singh M, Dwan K. Inhaled antibiotics for long-term therapy in cystic fibrosis. Cochrane Database Syst Rev 2011(3):CD001021. doi: 10.1002/14651858.CD001021.pub2
4. Moskowitz SM, Silva SJ, Mayer-Hamblett N, et al. Shifting patterns of inhaled antibiotic use in cystic fibrosis. Pediatr Pulmonol 2008;43:874-881.
5. Product information. Cayston (aztreonam for inhalation solution). Foster City, CA: Gilead Sciences, Inc., February 2010.
6. Heijerman H, Westerman E, Conway S, Touw D. Inhaled medication and inhalation devices for lung disease in patients with cystic fibrosis: a European consensus. J Cystic Fibrosis 2009;8:295-315.
7. Aztreonam lysine. Clinicaltrials.gov. www.clinicaltrials.gov (accessed 2012 Jun 22).
8. Dietzsch HJ, Gottschalk B, Heyne K, Leupoid W. Cystic fibrosis: comparison of two mucolytic drugs for inhalation treatment (acetylcysteine and arginine hydrochloride). Pediatrics 1975;55:96-100.
9. Gibson RL, Retsch-Bogart GZ, Oermann C, et al. Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Pediatr Pulmonol 2006;41:656-665.
10. Mendelman PM, Smith AL, Levy J, Weber A, Ramsay B, Davis RL. Aminoglycoside penetration, inactivation, and efficacy in cystic fibrosis sputum. Am Rev Respir Dis 1985;132:761-765.
11. Hunt BE, Weber A, Berger A, Ramsay B, Smith AL. Macromolecular mechanisms of sputum inhibition of tobramycin activity. Antimicrob Agents Chemother 1995;39:34-39.
12. Swabb EA, Sugerman AA, Platt TB, Pilkiewicz FG, Frantz M. Singledose pharmacokinetics of the monobactam aztreonam (SQ 26,776) in healthy subjects. Antimicrob Agents Chemother 1982;21:944-949.
13. Swabb EA, Singhvi SM, Leitz MA, Frantz M, Sugerman A. Metabolism and pharmacokinetics of aztreonam in healthy subjects. Antimicrob Agents Chemother 1983;24:394-400.
14. European Medicines Agency. European public assessment report-product information. www.emea.europa.eu (accessed 2012 Jun 22).
15. McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med 2008;178:921-928.
16. Retsch-Bogart GZ, Burns JL, Otto KL, et al. A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatr Pulmonol 2008;43:47-58.
17. Retsch-Bogart GZ, Quittner AL, Gibson RL, et al. Efficacy and safety of inhaled aztreonam lysine for airway Pseudomonas in cystic fibrosis. Chest 2009;135:1223-1232.
18. US Food and Drug Administration. Drugs @ FDA. Drug approval package. Center for Drug Evaluation and Research. Clinical Pharmacology Biopharmaceutics Review(s). Application number: 050814. www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814s000_cayston_toc.cfm (accessed 2012 Jun 22).
19. Vinks AA, van Rossem RN, Mathot RAA, Heijerman HGM, Mouton JW. Pharmacokinetics of aztreonam in healthy subjects and patients with cystic fibrosis and evaluation of dose-exposure relationships using Monte Carlo simulation. Antimicrob Agents Chemother 2007;51:3049-3055.
20. Okusanya OO, Bhavnani SM, Hammel J, et al. Pharmacokinetic and pharmacodynamic evaluation of liposomal amikacin for inhalation in cystic fibrosis patients with chronic pseudomonal infection. Antimicrob Agents Chemother 2009;53:3847-3854.
21. Smith AL. Inhaled antibiotic therapy: What drug? What dose? What regimen? What formulation? J Cystic Fibrosis 2002;1(suppl 2):S189-S193.
22. Hoiby N. Recent advances in the treatment of Pseudomonas aeruginosa infections in cystic fibrosis. BMC Med 2011;9:32. doi: 10.1186/1741-7015-9-32.
23. Oermann CM, Retsch-Bogart GZ, Quittner AL, et al. An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. Pediatr Pulmonol 2010;45:1121-1134.
24. McCoy K, Retsch-Bogart G, Gibson RL, Oermann C, Braff M, Montgomery AB. Investigation of susceptibility breakpoints for inhaled antibiotic therapies in cystic fibrosis (abstract 340). Pediatr Pulmonol 2010;45(suppl 33):341.
25. Pressler T, Assael BM, Fischer R, et al. In vitro susceptibility of Pseudomonas aeruginosa (PA) does not predict clinical response to aztreonam 75 mg powder and solvent for nebuliser solution (AZLI): a responder analysis in subjects with cystic fibrosis (CF). J Cystic Fibrosis 2011;10(suppl 1):S27.
26. Plosker GL. Aztreonam lysine for inhalation solution in cystic fibrosis. Drugs 2010;70:1843-1855.
27. Quittner AL, Modi AC, Wainwright C, Otto K, Kirihara J, Montgomery AB. Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Chest 2009;135:1610-1618.
28. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson RL, McKevitt M, Montgomery AB. Pseudomonas aeruginosa antibiotic susceptibility during long-term use of aztreonam for inhalation solution. J Antimicrob Chemother 2011;66:2398-2404.
29. Wainwright CE, Quittner AL, Geller DE, et al. Aztreonam for inhalation solution in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. J Cystic Fibrosis 2011;10:234-242.
30. Oermann CM, Lewis S, Bresnik M, Assael B. Change in FEV1% predicted in response to aztreonam for inhalation solution (AZLI) vs tobramycin inhalation solution (TIS) in an active comparator study: responder analysis (abstract 216). Pediatr Pulmonol 2011;46(suppl 34):289.
31. Tullis E, Burns JL, Retsch-Bogart G, et al. Aztreonam for inhalation solution (AZLI) in cystic fibrosis (CF) patients with chronic Burkholderia species (BURK) infection: initial results from a randomized, placebocontrolled trial (abstract 234). Pediatr Pulmonol 2011;46(suppl 34):296.
32. Quittner AL, Buu A, Messer MA, Modi AC, Watrous M. Development and validation of the Cystic Fibrosis Questionnaire in the United States: a health-related quality-of-life measure for cystic fibrosis. Chest 2005;128: 2347-2354.
33. PARI USA. Altera nebulizer system. Instructions for use. http://pariproducts.com/downloads/678D1004_Rev_G_Altera_IFU.pdf (accessed 2012 Jun 22).
34. CF Services Pharmacy Web site. www.cfservicespharmacy.com (accessed 2012 Jun 22).
35. Cayston Access Program. www.cayston.com/cayston-access-program.html (accessed 2012 Jun 22).
36. Aztreonam for inhalation solution (Cayston) for cystic fibrosis. Med Lett Drugs Ther 2010; 52:63-64.
37. Kesser KC, Geller DE. New aerosol delivery devices for cystic fibrosis. Respir Care 2009;54;754-756.