Dry powder inhalers in cystic fibrosis: Same old drugs but different benefits?

Current Opinion in Pulmonary Medicine

Volumn 20, Issue 6, 2014, Pages 607-612

  Uttley, Lesley ^a   Tappenden, Paul ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

Antipseudomonal antibiotics; Dry powder; Health technology assessment; Pseudomonas aeruginosa; Systematic review

Indexed keywords

COLISTIMETHATE; TOBRAMYCIN; ANTIINFECTIVE AGENT; COLISTIN; COLISTINMETHANESULFONIC ACID;

ANTIBIOTIC THERAPY; CYSTIC FIBROSIS; DRUG EFFICACY; DRUG SAFETY; DRY POWDER INHALER; EXPERIMENTAL THERAPY; HUMAN; LUNG INFECTION; NONHUMAN; PSEUDOMONAS AERUGINOSA; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SUNK COST EFFECT; SYSTEMATIC REVIEW (TOPIC); ANALOGS AND DERIVATIVES; COMPLICATION; COST BENEFIT ANALYSIS; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; MEDICATION COMPLIANCE; PATHOPHYSIOLOGY; PSEUDOMONAS INFECTIONS; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ANTI-BACTERIAL AGENTS; COLISTIN; COST-BENEFIT ANALYSIS; CYSTIC FIBROSIS; DRY POWDER INHALERS; HUMANS; MEDICATION ADHERENCE; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; TOBRAMYCIN; TREATMENT OUTCOME;

EID: 84927788695     PISSN: 10705287     EISSN: 15316971     Source Type: Journal    
DOI: 10.1097/MCP.0000000000000109     Document Type: Review

References (34)

1. Cystic Fibrosis Trust. UK Cystic Fibrosis Registry Annual Data Report 2010; December 2011:1-67.
2. George PM, Banya W, Pareek N, et al. Improved survival at low lung function in cystic fibrosis: cohort study from 1990 to 2007. BMJ 2011; 342:d1008.
3. Høiby N. Recent advances in the treatment of Pseudomonas aeruginosa infections in cystic fibrosis. BMC Med 2011; 9:32.
4. McKeage K. Tobramycin inhalation powder: a review of its use in the treatment of chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis. Drugs 2013; 73:1815-1827.
5. Conole D, Keating GM. Colistimethate sodium dry powder for inhalation: a review of its use in the treatment of chronic infection in patients with cystic fibrosis. Drugs 2014; 74:377-387.
6. Piaggio G, Elbourne DR, Altman DG, et al., CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295:1152-1160.
7. Wertheimer AI, Santella TM. Pharmacoevolution: the advantages of incremental innovation. IPN Working Papers on Intellectual Property, Innovation and Health 2004.
8. National Institute for Health and Clinical Excellence. Colistimethate sodium powder and tobramycin powder for inhalation for the treatment of pseudomonas lung infection in cystic fibrosis - final scope 2011; NICE: London.
9. Tappenden P, Harnan S, Uttley L, et al. Colistimethate sodium powder and tobramycin powder for inhalation for the treatment of chronic Pseudomonas aeruginosa lung infection in cystic fibrosis: systematic review and economic model. Health Technol Assess 2013; 17:1-182. This monograph details the methods and results of the technology assessment of colistimethate sodium DPI and tobramycin DPI for the treatment of chronic P. aeruginosa lung infection in cystic fibrosis. The research study includes a systematic review and economic evaluation of these treatments as compared against nebulized antibiotics. This forms the basis of the independent scientific evidence used to inform NICE Appraisal Committee's deliberations prior to issuing national guidance.
10. Uttley L, Harnan S, Cantrell A, et al. Systematic review of the dry powder inhalers colistimethate sodium and tobramycin in cystic fibrosis. Eur Respir Rev 2013; 22:476-486.
11. Tappenden P, Harnan S, Uttley L, et al. The cost effectiveness of dry powder antibiotics for the treatment of Pseudomonas aeruginosa in patients with cystic fibrosis. Pharmacoeconomics 2014; 32:159-172.
12. Forest Laboratories UK Ltd. Colistimethate sodium powder for inhalation for the treatment of Pseudomonas lung infection in cystic fibrosis - Forest Submission to NICE. Forest Laboratories UK: Kent. 2011.
13. Novartis Pharmaceuticals. Colistimethate sodium powder (Colobreathe1) and tobramycin powder for inhalation (TOBI Podhaler1) for the treatment of Pseudomonas lung infection in cystic fibrosis - Novartis submission to NICE. Novartis Pharmaceuticals: Surrey. 2011.
14. Dias S, Welton NJ, Sutton AJ, Ades AE. NICE Decision Support Unit Technical Support Document 1: introduction to evidence synthesis for decision making. 2011. 1-24.
15. Schuster A, Haliburn C, Döring G, Goldman MH. Freedom Study Group. Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised study. Thorax 2013; 68:344-350. This monograph details the methods and results of the technology assessment of colistimethate sodium DPI and tobramycin DPI for the treatment of chronic P. aeruginosa lung infection in CF. The research study includes a systematic review and economic evaluation of these treatments as compared against nebulized antibiotics. This forms the basis of the independent scientific evidence used to inform NICE Appraisal Committee's deliberations prior to issuing national guidance.
16. Davies JC, Hall P, Francis J, et al. A dry powder formulation of colistimethate sodium is safe and well tolerated in adults and children with CF. Pediatr Pulmon 2004; 38 (Suppl 27):283.
17. Konstan MW, Flume PA, Kappler M, et al. Safety efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: the EAGER trial. J Cyst Fibros 2011; 10:54-61.
18. Konstan M, Flume PA, Brockhaus F, et al. Safety and efficacy of tobramycin inhalation powder (TIP) in treating CF patients infected with Pseudomonas aeruginosa (Pa). J Cyst Fibros 2010; 9 (Suppl 1):S22-S122.
19. Konstan MW, Geller DE, Minic P, et al. Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: the EVOLVE trial. Pediatr Pulmonol 2011; 46:230-238.
20. Geller DE, Flume PA, Brockhaus F, et al. Treatment convenience and satisfaction of tobramycin inhalation powder (TIP) versus TOBI in cystic fibrosis (CF) patients. J Cyst Fibros 2010; 9 (Suppl 1):S22-S122.
21. Committee for Medicinal Products for Human Use (CHMP). Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis. 2009.
22. European Medicines Agency. Assessment report - Tobi Podhaler http://www. ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment- report/human/002155/WC500110922.pdf.
23. Zemanick ET, Harris JK, Conway S, et al. Measuring and improving respiratory outcomes in cystic fibrosis lung disease: opportunities and challenges to therapy. J Cyst Fibros 2010; 9:1-16.
24. Bilton D, Canny GJ, Conway S, et al. Pulmonary exacerbation: towards a definition for use in clinical trials. J Cyst Fibros 2011; 10 (Suppl 2): S79-S81.
25. British National Formulary. Joint Formulary Committee 2014.
26. Drummond MF, Sculpher MJ, Torrance GW, et al. Methods for the economic evaluation of healthcare programmes. 3rd ed. Oxford: Oxford University Press; 2005.
27. National Institute for Health and Care Excellence. Guide to the methods of technology appraisal. April 2013. NICE, London.
28. Thornton J, Elliott RA, Tully MP, et al. Clinical and economic choices in the treatment of respiratory infections in cystic fibrosis: comparing hospital and home care. J Cyst Fibros 2005; 4:239-247.
29. Wolter JM, Bowler SD, Nolan PJ, McCormack JG. Home intravenous therapy in cystic fibrosis: a prospective randomized trial examining clinical, quality of life and cost aspects. Eur Respir J 1997; 10:896-900.
30. Iles R, Legh-Smith J, Drummond M, et al. Economic evaluation of tobramycin nebuliser solution in cystic fibrosis. J Cyst Fibros 2003; 2:120-128.
31. Sonnenberg FA, Beck JR. Markov models in medical decision making a practical guide. Med Decis Making 1993; 13:322-338.
32. National Institute for Health and Care Excellence. Colistimethate sodium and tobramycin dry powders for inhalation for treating pseudomonas lung infection in cystic fibrosis. NICE Technology Appraisal Guidance 2013. NICE: London. This report details the 2013 NICE guidance on the use of DPI antibiotics in the NHS in England and Wales.
33. Denk O, Coates AL, Keller M, et al. Lung delivery of a new tobramycin nebuliser solution (150mg/1.5 ml) by an investigational eFlow nebuliser is equivalent to TOBI but in a fraction of time. J Cyst Fibros 2009; 8 (Suppl 2):S66-S166.
34. Keller M, Coates AL, Griese M, et al. In-vivo data support equivalent therapeutic efficacy of a new tobramycin inhalation solution (150 mg/1.5 ml) administered by the eFlow electronic nebuliser compared to TOBI in the PARI LC PLUS. J Cyst Fibros 2010; 9 (Suppl 1):S22-S122.