Fidaxomicin: A novel macrocyclic antibiotic for the treatment of Clostridium difficile infection

American Journal of Health-System Pharmacy

Volumn 69, Issue 11, 2012, Pages 933-943

  Crawford, Tonya ^a   Huesgen, Emily ^a   Danziger, Larry ^a  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; FIDAXOMICIN; METRONIDAZOLE; OP 1118; UNCLASSIFIED DRUG; VANCOMYCIN;

AMYLASE BLOOD LEVEL; AREA UNDER THE CURVE; BACTERIAL COLONIZATION; BACTERIUM IDENTIFICATION; BACTERIUM ISOLATION; CHILL; CLOSTRIDIUM DIFFICILE INFECTION; CONJUNCTIVITIS; DIARRHEA; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; EOSINOPHILIA; FATIGUE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL TRACT; GRAM NEGATIVE BACTERIUM; HEADACHE; HEMATOLOGIC DISEASE; HUMAN; HYPOGLYCEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; IN VITRO STUDY; IN VIVO STUDY; LEUKOPENIA; LYMPHATIC SYSTEM DISEASE; MICROBIOLOGY; MINIMUM INHIBITORY CONCENTRATION; PHARYNGITIS; PNEUMONIA; PRIORITY JOURNAL; RECURRENT DISEASE; RESPIRATORY TRACT INFECTION; REVIEW; RHINORRHEA; SIDE EFFECT; TREATMENT OUTCOME; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; URINARY TRACT INFECTION; WEAKNESS;

EID: 84861471589     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp110371     Document Type: Review

References (54)

1. Miller BA, Chen LF, Sexton DJ et al. Comparison of the burdens of hospital-onset, healthcare facility-associated Clostridium difficile infection and of healthcare-associated infection due to methicillin-resistant Staphylococcus aureus in community hospitals. Infect Control Hosp Epidemiol. 2011; 32:387-90.
2. Freeman J, Bauer MP, Baines SD et al. The changing epidemiology of Clostridium difficile infections. Clin Microbiol Rev. 2010; 23:529-49.
3. Loo VG, Poirier L, Miller MA et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005; 353:2442-9. (Pubitemid 41770165)
4. McDonald LC, Killgore GE, Thompson A et al. An epidemic, toxin gene-variant strain of Clostridium difficile. N Engl J Med. 2005; 353:2433-41. (Pubitemid 41770164)
5. Centers for Disease Control and Prevention (CDC). Severe Clostridium difficile-associated disease in populations previously at low risk-four states, 2005. MMWR Morb Mortal Wkly Rep. 2005; 54:1201-5.
6. Swingler E, Cameron S, Riley T. Clostridium difficile at a teaching hospital in Western Australia: providing insight into community acquisition. Paper presented at 18th European Congress of Clinical Microbiology and Infectious Diseases. Barcelona, Spain; 2008 Apr 19.
7. Vicente MR, Pariente M, Riquelme E et al. Clostridium difficile-associated diseases: a 2-year study. Paper presented at 18th European Congress of Clinical Microbiology and Infectious Diseases. Barcelona, Spain; 2008 Apr 19.
8. Dial S, Delaney JA, Barkun AN et al. Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile-associated disease. JAMA. 2005; 294:2989-95. (Pubitemid 41817660)
9. Dubberke ER, Haslam DB, Lanzas C et al. The ecology and pathobiology of Clostridium difficile infections: an interdisciplinary challenge. Zoonoses Public Health. 2011; 58:4-20.
10. Voth DE, Ballard JD. Clostridium difficile toxins: mechanisms of action and role in disease. Clin Microbiol Rev. 2005; 18:247-63. (Pubitemid 40548293)
11. Sullivan NM, Pellett S, Wilkins TD. Purification and characterization of toxins A and B of Clostridium difficile. Infect Immun. 1982; 35:1032-40.
12. Just I, Fritz G, Aktorics K et al. Clostridium difficile toxin B acts on the GTP-binding protein rho. J Biol Chem. 1994; 269:10706-12.
13. Norèn T. Clostridium difficile and the disease it causes. Methods Mol Biol. 2010; 646:9-35.
14. Kelly CP, LaMont JT. Clostridium difficile-more difficult than ever. N Engl J Med. 2008; 359:1932-40.
15. Barth H, Aktories K, Popoff MR et al. Binary bacterial toxins: biochemistry, biology, and applications of common Clostridium and Bacillus proteins. Microbiol Mol Biol Rev. 2004; 68:373-402. (Pubitemid 39238275)
16. Geric B, Carman RJ, Rupnik M et al. Binary toxin-producing, large clostridial toxin-negative Clostridium difficile strains are enterotoxic but do not cause disease in hamsters. J Infect Dis. 2006; 193:1143-50.
17. Barbut F, Decré D, Lalande V et al. Clinical features of Clostridium difficile-associated diarrhoea due to binary toxin (actin-specific ADP-ribosyltransferase)-producing strains. J Med Microbiol. 2005; 54(pt 2):181-5. (Pubitemid 40868005)
18. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55.
19. Bauer MP, van Dissel JT, Kuijper EJ. Clostridium difficile: controversies and approaches to management. Curr Opin Infect Dis. 2009; 22:517-24.
20. McFarland LV. Alternative treatments for Clostridium difficile disease: what really works? J Med Microbiol. 2005; 54(pt 2):101-11. (Pubitemid 40867993)
21. Zar FA, Bakkanagari SR, Moorthi KM et al. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007; 45:302-7. (Pubitemid 47101025)
22. Check Orphan. Optimer Pharmaceuticals receives orphan drug designation for fidaxomicin for the treatment of pediatric Clostridium difficile infection. www.checkorphan.org/grid/news/treatment/optimer-pharmaceuticals-receives-orphan- drug-designationfor- fidaxomicin-for-the-treatment-of-pediatric-clostridium- difficile-infection (accessed 2011 Jun 13).
23. FDA News. FDA panel unanimously recommends approval of Optimer's fidaxomicin. www.fdanews.com/newsletter/article?issueId=14615&articleId= 135661 (accessed 2011 Jun 13).
24. Parenti F, Pagani H, Beretta G. Lipiarmycin, a new antibiotic from Actinoplanes. I. Description of the producer strain and fermentation studies. J Antibiot. 1975; 28:247-52.
25. Coronelli C, White RJ, Lancini GC et al. Lipiarmycin, a new antibiotic from Actinoplanes. II. Isolation, chemical, biological and biochemical characterization. J Antibiot. 1975; 28:253-9.
26. Theriault RJ, Karwowski JP, Jackson M et al. Tiacumicins, a novel complex of 18-membered macrolide antibiotics. I. Taxonomy, fermentation, and antibacterial activity. J Antibiot. 1987; 40:567-74. (Pubitemid 17072152)
27. Hochlowski JE, Swanson SJ, Ranfranz LM et al. Tiacumicins, a novel complex of 18-membered macrolides. II. Isolation and structure determination. J Antibiot. 1987; 40:575-88. (Pubitemid 17072153)
28. Optimer Pharmaceuticals. www.optimerpharma. com/gallery/090207-Optimer- Poster-FINAL59827-93.pdf (accessed 2011 Jun 13).
29. Shue YK, Sears PS, Shangle S et al. Safety, tolerance, and pharmacokinetic studies of OPT-80 in healthy volunteers following single and multiple oral doses. Antimicrob Agents Chemother. 2008; 52:1391-5. (Pubitemid 351522003)
30. Osburne MS, Sonenshein AL. Inhibition by lipiarmycin of bacteriophage growth in Bacillus subtilis. J Virol. 1980; 33:945-53. (Pubitemid 10184105)
31. Gualtieri M, Villain-Guillot P, Latouche J et al. Mutation in the Bacillus subtilis RNA polymerase beta' subunit confers resistance to lipiarmycin. Antimicrob Agents Chemother. 2006; 50:401-2. (Pubitemid 43042959)
32. Wöstem MM. Eubacterial sigma-factors. FEMS Microbiol Rev. 1998; 22:127-50.
33. Babakhani F, Shangle S, Robert N et al. Resistance development, cross-resistance and synergy studies of OPT-80. Paper presented at 44th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC; 2004 Oct 30.
34. Ackermann G, Löffler B, Adler D et al. In vitro activity of OPT-80 against Clostridium difficile. Antimicrob Agents Chemother. 2004; 48:2280-2. (Pubitemid 38691631)
35. Credito KL, Appelbaum PC. Activity of OPT-80, a novel macrocycle, compared with those of eight other agents against selected anaerobic species. Antimicrob Agents Chemother. 2004; 48:4430-4. (Pubitemid 39434908)
36. Finegold SM, Molitoris D, Vaisanen ML et al. In vitro activities of OPT-80 and comparator drugs against intestinal bacteria. Antimicrob Agents Chemother. 2004; 48:4898-902. (Pubitemid 39577704)
37. Swanson RN, Hardy DJ, Shipkowitz NL et al. In vitro and in vivo evaluation of tiacumicins B and C against Clostridium difficile. Antimicrob Agents Chemother. 1991; 35:1108-11.
38. Citron DM, Babakhani F, Goldstein EJ et al. Typing and susceptibility of bacterial isolates from the fidaxomicin (OPT-80) phase II study for C. difficile infection. Anaerobe. 2009; 15:234-6.
39. Hecht DW, Galang MA, Sambol SP et al. In vitro activities of 15 antimicrobial agents against 110 toxigenic Clostridium difficile clinical isolates collected from 1983 to 2004. Antimicrob Agents Chemother. 2007; 51:2716-9. (Pubitemid 47206204)
40. Louie TJ, Emery J, Krulicki W et al. OPT-80 eliminates Clostridium difficile and is sparing of Bacteroides species during treatment of C. difficile infection. Antimicrob Agents Chemother. 2009; 53:261-3.
41. Babakhani FK, Seddon J, Robert N et al. Narrow spectrum activity and low fecal binding of OPT-80 and its major hydrolysis metabolite (OP-1118). Paper presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy. Chicago, IL; 2007 Sep 17.
42. Nerandzic MM, Mullane K, Miller M et al. Acquisition and overgrowth of vancomycin-resistant enterococci in patients treated with fidaxomicin (FDX) versus vancomycin for Clostridium difficile infection. Paper presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA; 2009 Sep 12.
43. Babakhani F, Gomez A, Sears P. Fidaxomicin and vancomycin postantibiotic effect against C. difficile. Paper presented at 10th Biennial Congress of the Anaerobe Society of the Americas. Philadelphia, PA; 2010 Jul 7.
44. Babakhani F, Seddon J, Robert N et al. Effects of inoculum, pH, and cations on the in vivo activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile. Antimicrob Agents Chemother. 2010; 54:2674-6.
45. Louie T, Miller M, Donskey C et al. Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection. Antimicrob Agents Chemother. 2009; 53:223-8.
46. Crook D, Peto T, Miller M et al. Efficacy and safety of fidaxomicin (FDX) vs vancomycin (VAN) in Clostridium difficile infection (CDI) in 2 randomized controlled trials (RCT) with 1105 patients. Paper presented at the 48th Infectious Diseases Society of America Annual Meeting. Vancouver, Canada; 2010 Oct 23.
47. Crook D, Weiss K, Cornely O et al. Randomized clinical trial (RCT) in Clostridium difficile (CDI) infection confirms equivalent cure rate and lower recurrence rate of fidaxomicin (FDX) versus vancomycin (VCN). Paper presented at the 20th European Congress of Clinical Microbiology and Infectious Diseases. Vienna, Austria; 2010 Apr 10.
48. Louie TJ, Miller MA, Mullane KM et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011; 364:422-31.
49. Food and Drug Administration. Anti-Infective Drugs Advisory Committee meeting briefing document: Dificid (fidaxomicin tablets) for the treatment of Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and for reducing the risk of recurrence when used for treatment of initial CDI. www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti- InfectiveDrugsAdvisoryCommittee/UCM249354.pdf (accessed 2011 Jun 8).
50. Dificid (fidaxomicin) package insert. San Diego, CA: Optimer Pharmaceuticals, Inc.; 2011 May.
51. Musher DM, Aslam S, Logan N et al. Relatively poor outcome after treatment of Clostridium difficile colitis with metronidazole. Clin Infect Dis. 2005; 40:1586-90. (Pubitemid 40720807)
52. Pepin J, Alary ME, Valiquette L et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005; 40:1591-7. (Pubitemid 40720808)
53. Murray L, ed. Red book: pharmacy's fundamental reference. 2010 ed. Montvale: Thomson Reuters (Healthcare) Inc.; 2010.
54. FirstWord. Optimer Pharmaceuticals to price Dificid at twice the cost of other C. diff treatments. www.firstwordplus.com/Fws.do?articleid= 7B3E908A05444A658 68BAA422B925C33 (accessed 2011 Jun 15).