Use of pharmacokinetic-pharmacodynamic analyses to optimize therapy with the systemic antifungal micafungin for invasive candidiasis or candidemia

Antimicrobial Agents and Chemotherapy

Volumn 55, Issue 5, 2011, Pages 2113-2121

  Andes, David ^a   Ambrose, Paul G ^b   Hammel, Jeffrey P ^b   Van Wart, Scott A ^b   Iyer, Varsha ^b   Reynolds, Daniel K ^b   Buell, Donald N ^c   Kovanda, Laura L ^c   Bhavnani, Sujata M ^b  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^b INSTITUTE FOR CLINICAL PHARMACODYNAMICS   (United States)

^c Astellas Pharma US Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; ECHINOCANDIN; MICAFUNGIN;

ADOLESCENT; ADULT; AGED; APACHE; AREA UNDER THE CURVE; ARTICLE; CANDIDA ALBICANS; CANDIDA GLABRATA; CANDIDA KRUSEI; CANDIDA PARAPSILOSIS; CANDIDA TROPICALIS; CANDIDEMIA; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; HUMAN; INVASIVE CANDIDIASIS; MAJOR CLINICAL STUDY; MALE; MINIMUM INHIBITORY CONCENTRATION; MONTE CARLO METHOD; NONHUMAN; OUTCOME ASSESSMENT; PHARMACODYNAMICS; PREDICTION; PRIORITY JOURNAL; SYSTEMIC THERAPY; TREATMENT RESPONSE;

ANTIFUNGAL AGENTS; CANDIDEMIA; CANDIDIASIS; CLINICAL TRIALS, PHASE III AS TOPIC; ECHINOCANDINS; FEMALE; HUMANS; LIPOPEPTIDES; MALE; MICROBIAL SENSITIVITY TESTS; MIDDLE AGED; MONTE CARLO METHOD; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 79955539687     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01430-10     Document Type: Article

References (55)

1. Ambrose, P. G. 2010. PK-PD in the development of antimicrobial agents for resistant pathogens: it's about the magnitude, shape and duration of drug exposure. In Proceedings from Issues in Antibacterial Resistance and Device and Drug Development. Food and Drug Administration, National Institute of Allergy and Infectious Diseases, and Infectious Diseases Society of America, Washington, DC. http://www.fda.gov/Drugs /NewsEvents/ucm211146.htm.
2. Ambrose, P. G., et al. 2007. Pharmacokinetics-pharmacodynamics of antimicrobial therapy: it's not just for mice anymore. Clin. Infect. Dis. 44:79-86.
3. Andes, D. 2003. In vivo pharmacodynamics of antifungal drugs in treatment of candidiasis. Antimicrob. Agents Chemother. 47:1179-1186.
4. Andes, D., and W. A. Craig. 2003. Pharmacodynamics of the new des-f(6)- quinolone garenoxacin in a murine thigh infection model. Antimicrob. Agents Chemother. 47:3935-3941.
5. Andes, D., and W. A. Craig. 2002. Pharmacodynamics of the new fluoroquinolone gatifloxacin in murine thigh and lung infection models. Antimicrob. Agents Chemother. 46:1665-1670.
6. Andes, D., et al. 2008. In vivo pharmacodynamic characterization of anidulafungin in a neutropenic murine candidiasis model. Antimicrob. Agents Chemother. 52:539-550.
7. Andes, D., et al. 2003. In vivo pharmacodynamics of HMR 3270, a glucan synthase inhibitor, in a murine candidiasis model. Antimicrob. Agents Chemother. 47:1187-1192.
8. Andes, D. R., D. J. Diekema, M. A. Pfaller, K. Marchillo, and J. Bohrmueller. 2008. In vivo pharmacodynamic target investigation for micafungin against Candida albicans and C. glabrata in a neutropenic murine candidiasis model. Antimicrob. Agents Chemother. 52:3497-3503.
9. Andes, D., et al. 2010. In vivo comparison of the pharmacodynamic target among echinocandin drugs and Candida species. Antimicrob. Agents Chemother. 54:2497-2506.
10. Arendrup, M., T. Horn, and N. Frimodt-Møller. 2002. In vivo pathogenicity of eight medically relevant Candida species in an animal model. Infection 30:286-291.
11. Baddley, J. W., M. Patel, S. M. Bhavnani, S. A. Moser, and D. R. Andes. 2008. Association of fluconazole pharmacodynamics with mortality in patients with candidemia. Antimicrob. Agents Chemother. 52:3022-3028.
12. Chandrasekar, P. H., and J. D. Sobel. 2006. Micafungin: a new echinocandin. Clin. Infect. Dis. 42:1171-1178.
13. Clinical and Laboratory Standards Institute. 2008. Development of in vitro susceptibility testing criteria and quality control parameters, 3rd ed. Approved guideline M23-A3. Clinical and Laboratory Standards Institute, Wayne, PA.
14. Craig, W. A. 1998. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin. Infect. Dis. 26:1-10.
15. Drusano, G. L. 2007. Pharmacodynamics of antivirals. In C. H. Nightingale, P. G. Ambrose, G. L. Drusano, and T. Murakawa (ed.), Antimicrobial pharmacodynamics in theory and clinical practice, 2nd ed. Informa Healthcare, New York, NY.
16. European Committee on Antimicrobial Susceptibility Testing. 2010. European Society of Clinical Microbiology and Infectious Diseases. http://www .eucast.org. Accessed 18 June 2010.
17. Garcia-Effron, G., D. P. Kontoyiannis, R. E. Lewis, and D. S. Perlin. 2008. Caspofungin-resistant Candida tropicalis strains causing breakthrough fungemia in patients at high risk for hematologic malignancies. Antimicrob. Agents Chemother. 52:4181-4183.
18. Hakki, M., J. F. Staab, and K. A. Marr. 2006. Emergence of a Candida krusei isolate with reduced susceptibility to caspofungin during therapy. Antimicrob. Agents Chemother. 50:2522-2524.
19. Hebert, M. F., et al. 2005. Pharmacokinetics of micafungin in healthy volunteers, volunteers with moderate liver disease, and volunteers with renal dysfunction. J. Clin. Pharmacol. 45:1145-1152.
20. Hernandez, S., et al. 2004. Caspofungin resistance in Candida albicans: correlating clinical outcome with laboratory susceptibility testing of three isogenic isolates serially obtained from a patient with progressive Candida esophagitis. Antimicrob. Agents Chemother. 48:1382-1383.
21. Hosmer, D. W., and S. Lemeshow. 1989. Applied logistic regression. John Wiley & Sons, Inc., New York, NY.
22. Kartsonis, N., et al. 2005. Caspofungin susceptibility testing of isolates from patients with esophageal candidiasis or invasive candidiasis: relationship of MIC to treatment outcome. Antimicrob. Agents Chemother. 49:3616-3623.
23. Krogh-Madsen, M., M. C. Arendrup, L. Heslet, and J. D. Knudsen. 2006. Amphotericin B and caspofungin resistance in Candida glabrata isolates recovered from a critically ill patient. Clin. Infect. Dis. 42:938-944.
24. Kuse, E. R., et al. 2007. Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. Lancet 369:1519-1527.
25. Laverdière, M., et al. 2006. Progressive loss of echinocandin activity following prolonged use for treatment of Candida albicans oesophagitis. J. Antimicrob. Chemother. 57:705-708.
26. Louie, A., et al. 2005. Pharmacodynamics of caspofungin in a murine model of systemic candidiasis: importance of persistence of caspofungin in tissues to understanding drug activity. Antimicrob. Agents Chemother. 49:5058-5068.
27. Merck & Co., Inc. 2009. Cancidas (caspofungin acetate) for injection, for intravenous use. Package insert. Merck & Co., Inc., Whitehouse Station, NJ.
28. Miller, C. D., B. W. Lomaestro, S. Park, and D. S. Perlin. 2006. Progressive esophagitis caused by Candida albicans with reduced susceptibility to caspofungin. Pharmacotherapy 26:877-880.
29. Mora-Duarte, J., et al. 2002. Comparison of caspofungin and amphotericin B for invasive candidiasis. N. Engl. J. Med. 347:2020-2029.
30. Ostrosky-Zeichner, L., et al. 2003. Antifungal susceptibility survey of 2,000 bloodstream Candida isolates in the United States. Antimicrob. Agents Chemother. 47:3149-3154.
31. Paderu, P., et al. 2007. Serum differentially alters the antifungal properties of echinocandin drugs. Antimicrob. Agents Chemother. 51:2253-2256.
32. Pappas, P. G., et al. 2009. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin. Infect. Dis. 48:503-535.
33. Pappas, P. G., et al. 2003. A prospective observational study of candidemia: epidemiology, therapy, and influences on mortality in hospitalized adult and pediatric patients. Clin. Infect. Dis. 37:634-643.
34. Pappas, P. G., et al. 2007. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin. Infect. Dis. 45: 883-893.
35. Park, S., et al. 2005. Specific substitutions in the echinocandin target Fks1p account for reduced susceptibility of rare laboratory and clinical Candida sp. isolates. Antimicrob. Agents Chemother. 49:3264-3273.
36. Pfaller, M. A., et al. 2008. In vitro susceptibility of invasive isolates of Candida spp. to anidulafungin, caspofungin, and micafungin: six years of global surveillance. J. Clin. Microbiol. 46:150-156.
37. Pfaller, M. A., et al. 2006. Global surveillance of in vitro activity of micafungin against Candida: a comparison with caspofungin by CLSI-recommended methods. J. Clin. Microbiol. 44:3533-3538.
38. Pfaller, M. A., et al. 2005. In vitro activities of anidulafungin against more than 2,500 clinical isolates of Candida spp., including 315 isolates resistant to fluconazole. J. Clin. Microbiol. 43:5425-5427.
39. Pfaller, M. A., et al. 2006. In vitro susceptibilities of Candida spp. to caspofungin: four years of global surveillance. J. Clin. Microbiol. 44:760-763.
40. Pfaller, M. A., and D. J. Diekema. 2007. Epidemiology of invasive candidiasis: a persistent public health problem. Clin. Microbiol. Rev. 20:133-163.
41. Pfaller, M. A., et al. 2008. Geographic and temporal trends in isolation and antifungal susceptibility of Candida parapsilosis: a global assessment from the ARTEMIS DISK Antifungal Surveillance Program, 2001 to 2005. J. Clin. Microbiol. 46:842-849. (Pubitemid 351379967)
42. Pfaller, M. A., et al. 2008. Correlation of MIC with outcome for Candida species tested against caspofungin, anidulafungin, and micafungin: analysis and proposal for interpretive MIC breakpoints. J. Clin. Microbiol. 46:2620-2629.
43. Pfaller, M. A., et al. 2006. Correlation of MIC with outcome for Candida species tested against voriconazole: analysis and proposal for interpretive breakpoints. J. Clin. Microbiol. 44:819-826.
44. Pfizer, Inc. June 2009. Eraxis™ (anidulafungin) for injection. Package insert. Pfizer, Inc., New York, NY.
45. R Development Core Team. 2006. R: a language and environment for statistical computing. R. Foundation for Statistical Computing, Vienna, Austria. http://www.r-project.org/. Accessed 18 June 2010.
46. Reboli, A. C., et al. 2007. Anidulafungin versus fluconazole for invasive candidiasis. N. Engl. J. Med. 356:2472-2482.
47. Rex, J. H., et al. 1997. Development of interpretive breakpoints for antifungal susceptibility testing: conceptual framework and analysis of in vitro-in vivo correlation data for fluconazole, itraconazole, and Candida infections. Subcommittee on Antifungal Susceptibility Testing of the National Committee for Clinical Laboratory Standards. Clin. Infect. Dis. 24:235-247.
48. SAS. 2002. 9.1.3 service pack 3 for Windows. SAS, Inc., Cary, NC.
49. Scheiner, L. B., and S. L. Beal. 1981. Some suggestions for measuring predictive performance. J. Pharmacokinet. Biopharm. 9:503-512.
50. Stevens, D. A., M. Ichinomiya, Y. Koshi, and H. Horiuchi. 2006. Escape of Candida from caspofungin inhibition at concentrations above the MIC (paradoxical effect) accomplished by increased cell wall chitin; evidence for -1,6-glucan synthesis inhibition by caspofungin. Antimicrob. Agents Chemother. 50:3160-3161.
51. SYSTAT Software, Inc. 2004. SYSTAT® 11. SYSTAT Software, Inc., Richmond, CA.
52. van Asbeck, E. C., K. V. Clemons, and D. A. Stevens. 2009. Candida parapsilosis: a review of its epidemiology, pathogenesis, clinical aspects, typing and antimicrobial susceptibility. Crit. Rev. Microbiol. 35:283-309.
53. Van Wart, S. A., et al. 2008. Population pharmacokinetics of micafungin in patients with invasive candidiasis, candidemia and esophageal candidiasis, abstr. A-011. Abstr. 48th Annu. Intersci. Conf. Antimicrob. Agents Chemother. (ICAAC)-Infect. Dis. Soc. Am. (IDSA) 46th Annu. Meet. American Society for Microbiology and Infectious Diseases Society of America, Washington, DC.
54. Wiederhold, N. P., et al. 2004. Pharmacodynamics of caspofungin in a murine model of invasive pulmonary aspergillosis: evidence of concentration-dependent activity. J. Infect. Dis. 190:1464-1471.
55. Yamato, Y., et al. 2002. Pharmacokinetics of the antifungal drug micafungin in mice, rats, and dogs and in its in vitro protein binding and distribution to blood cells. Jpn. J. Chemother. 50:74-79.