Lipid formulations of amphotericin B: Recent developments in improving the therapeutic index of a gold standard

Infectious Diseases in Clinical Practice

Volumn 7, Issue SUPPL. 1, 1998, Pages

  Walsh, Thomas J ^a   Hiemenz, John ^b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b FLORIDA HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B CHOLESTEROL SULFATE; AMPHOTERICIN B DEOXYCHOLATE; AMPHOTERICIN B LIPID COMPLEX; LIPOSOME;

ANTIFUNGAL ACTIVITY; DRUG EFFICACY; DRUG FORMULATION; DRUG INDICATION; HUMAN; MYCOSIS; NEPHROTOXICITY; NONHUMAN; REVIEW;

EID: 0031897067     PISSN: 10569103     EISSN: None     Source Type: Journal    
DOI: 10.1097/00019048-199803000-00004     Document Type: Review

References (93)

1. Beck Sague CM, Jarvis WR Secular trends in the epidemiology of nosocomial fungal infections in the United States, 1980-1990 J Infect Dis 1993;167:1247-51.
2. Pannuti C, Gingrich R, Pfaller MA, et al. Nosocomial pneumonia in patients having bone marrow transplant: attributable mortality and risk factors. Cancer 1992;69: 2653-62.
3. Anaissie E. Opportunistic mycosis in the immunocompromised host: experience at a cancer center and review. Clin Infect Dis 1992;14(1 Suppl):43S-52S.
4. Meyers JD Fungal infections in bone marrow transplant patients. Semin Oncol 1990;17(6 Suppl):10-3.
5. De Bock R. Epidemiology of invasive fungal infections in bone marrow transplantation. Bone Marrow Transplant 1994;14(5 Suppl):1S-2S.
6. Tollemar J, Ericzon BG, Holmberg K, et al. The incidence and diagnosis of invasive fungal infections in liver transplant recipients. Transplant Proc 1990;22:242-4.
7. Kanj SS, Welty-Wolf K, Madden J, et al. Fungal infections in liver transplant recipients. Transplant Proc 1990;22: 242-4.
8. Walsh TJ, Gonzalez C, Lyman CA, et al. Invasive fungal infections in children. Adv Pediatr Infect Dis 1995;11: 187-290.
9. Mitchell TG, Perfect JR. Cryptococcosis in the era of AIDS - 100 years after the discovery of Cryptococcus neoformans. Clin Microbiol Rev 1995;8:515-48.
10. Rex JH, Rinaldi MG, Pfaller MA. Resistance of Candida species to fluconazole. Antimicrob Agents Chemother 1995;39:1-8.
11. Wingard JR. Importance of Candida species other than C. albicans as pathogens in oncology patients. Clin Infect Dis 1995;20:115-25.
12. Nguyen MH, Peacock JE Jr, Morris AJ, et al. The changing face of candidemia: emergence of non-Candida albicans species and antifungal resistance. Am J Med 1996;100:617-23.
13. Boutati EI, Anaissie EJ. Fusarium, a significant emerging pathogen in patients with hematologic malignancy: ten years' experience at a cancer center and implications for management. Blood 1997;90:999-1008.
14. Bodey GP. New fungal pathogens. Curr Clin Top Infect Dis 1997;17:205-35.
15. Sarosi GA. Amphotericin B: still the "gold standard" for antifungal therapy. Postgrad Med 1990;88:151-66.
16. Gallis HA, Drew RH, Pickard WW. Amphotericin B: 30 years of clinical experience. Rev Infect Dis 1990: 308-29.
17. Denning DW, Stevens DA. Antifungal and surgical treatment of invasive fungal aspergillosis: review of 2121 published cases Rev Infect Dis 1990;12:1147-201.
18. Walsh TJ, Dixon DM. Nosocomial aspergillosis: environmental microbiology, hospital epidemiology, diagnosis, and treatment. Eur J Epidemiol 1989;5:131-42.
19. Bangham AD. Liposomes: realizing their promise. Hosp Pract 1992;27:51-62.
20. Ostro MJ, Cullis PR. Use of liposomes as injectable-drug delivery systems. Am J Hosp Pharm 1989;46:1576-87
21. New RRC, Chance ML, Heath S. Antileishmanial activity of amphotericin and other antifungal agents entrapped in liposomes. J Antimicrob Chemother 1981;8:371-81.
22. Graybill JR, Craven PC, Taylor RL, et al. Treatment of murine cryptococcosis with liposome-associated amphotericin B. J Infect Dis 1982;145:748-52.
23. Taylor RL, Williams DM, Craven PC, et al. Amphotericin B in liposomes: a novel therapy for histoplasmosis. Am Rev Respir Dis 1982;125:610-1.
24. Lopez-Berestein G, Mehta R, Hopfer R, et al. Liposome-encapsulated amphotericin B for treatment of disseminated candidiasis in neutropenic mice. J Infect Dis 1984;150:278-83.
25. Lopez-Berestein G, Fainstein V, Hopfer RL, et al. Liposomal amphotericin B for the treatment of systemic fungal infections in patients with cancer: a preliminary study. J Infect Dis 1985;151:704-10
26. Lopez-Berestein G, Bodey GP, Frankel LS, et al. Treatment of hepatosplenic fungal infections with liposomal amphotericin B. J Clin Oncol 1987;5:310-7.
27. Janoff AS, Boni LT, Popescu MC, et al. Unusual lipid structures selectively reduce the toxicity of amphotericin B. Proc Natl Acad Sci USA 1988;85:6122-6.
28. Janoff AS, Perkins WR, Saleton SL, et al. Amphotericin B lipid complex (ABLCTM): a molecular rationale for the attenuation of amphotericin B related toxicities. J Liposome Res 1993;3:451-72.
29. Clark JM, Whitney RR, Olsen SJ, et al. Amphotericin B lipid complex therapy of experimental fungal infections in mice. Antimicrob Agents Chemother 1991;35:615-21.
30. Olsen SJ, Swerdel MR, Blue B, et al. Tissue distribution of amphotericin B lipid complex in laboratory animals. J Pharm Pharmacol 1991;43:831-5.
31. Mitsutake K, Kohno S, Miyazaki Y, et al. In vitro and in vivo antifungal activities of liposomal amphotericin B and amphotericin B lipid complex. Mycopathologia 1994; 128:13-7.
32. Perfect J, et al. Amphotericin B lipid complex in the treatment of experimental cryptococcal meningitis and disseminated candidosis J Antimicrob Chemother 1994;33: 73-81.
33. Clemons KV, Stevens DA. Comparative efficacies of amphotericin B lipid complex and amphotericin B deoxycholate suspension against murine blastomycosis. Antimicrob Agents Chemother 1991;35:2144-6.
34. Kan VL, Bennett JE, Amantea MA, et al. Comparative safety, tolerance, and pharmacokinetics of amphotericin B lipid complex and amphotericin B deoxycholate in healthy male volunteers J Infect Dis 1991;164:418-21.
35. Walsh TJ, Whitcomb T, Piscitelli S, et al. Safety, tolerance, and pharmacokinetics of amphotericin B lipid complex in children with hepatosplenic candidiasis Antimicrob Agents Chemother (in press).
36. Kline S, Larsen TA, Fieber L, et al. Limited toxicity of prolonged therapy with high doses of amphotericin B lipid complex. Clin Infect Dis 1995;21:1154-8.
37. Sharkey PK, Graybill JR, Johnson ES, et al. Amphotericin B lipid complex compared with amphotericin B in the treatment of cryptococcal meningitis in patients with AIDS. Clin Infect Dis 1996;22:315-21.
38. Anaissie EJ, White M, Uzun O, et al Amphotericin B lipid complex versus amphotericin B for treatment of invasive candidiasis: a prospective, randomized, multicenter trial [abstract LM21]. In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1995 Sep 18; San Francisco (CA). Washington (DC): American Society for Microbiology; 1995. p. 330.
39. Walsh TJ, Hiemenz JW, Seibel N, et al., the ABLC Antifungal Study Group. Amphotericin B lipid complex in patients with invasive fungal infections: analysis of safety and efficacy in 556 cases. In: Program and abstracts of the XIII International Society for Human & Animal Mycology; 1997. p. 221.
40. Wingard JR. Efficacy of amphotericin B lipid complex injection (ABLC) in bone marrow transplant recipients with life-threatening systemic mycoses. Bone Marrow Transplant 1997;19:343-7.
41. Wolff MA, Ramphal R. Use of amphotericin B lipid complex for treatment of disseminated cutaneous Fusarium infection in a neutropenic patient. Clin Infect Dis 1995; 20:1568-9.
42. Gonzalez CE, Couriel DR, Walsh TJ. Disseminated zygomycosis in a neutropenic patient: successful treatment with amphotericin B lipid complex and granulocyte colony-stimulating factor Clin Infect Dis 1997;24:192-6.
43. Patterson TS, Barton LL, Shehab ZM, et al. Amphotericin B lipid complex treatment of a leukemic child with disseminated Fusarium solani infection. Clin Pediatr 1996; 35:257-60.
44. Meis JFGM, Kullberg B-J, Pruszczynski M, et al. Severe osteomyelitis due to the zygomycete Apophysomyces elegans. J Clin Microbiol 1994;32:3078-81.
45. Naguib MT, Huycke MM, Pederson JA, et al. Apophysomyces elegans infection in a renal transplant recipient. Am J Kidney Dis 1995;26:381-4.
46. Okhuysen PC, Rex JH, Kapusta M, et al. Successful treatment of extensive posttraumatic soft-tissue and renal infections due to Apophysomyces elegans. Clin Infect Dis 1994;19:329-31.
47. Oliver MR, Van Voorhis WC, Boeckh M, et al. Hepatic mucormycosis in a bone marrow transplant recipient who ingested naturopathic medicine. Clin Infect Dis 1996;22:521-4.
48. Hospenthal DR, Byrd JC, Weiss RB. Successful treatment of invasive aspergillosis complicating prolonged treatment-related neutropenia in acute myelogenous leukemia with amphotericin B lipid complex. Med Pediatr Oncol 1995;25:119-22.
49. Sundar S, Murray HW. Cure of antimony-unresponsive Indian visceral leishmaniasis with amphotericin B lipid complex. J Infect Dis 1996;173:762-5
50. Guo LSS, Fielding RM, Lasic DD, et al. Novel antifungal drug delivery: stable amphotericin B-cholesteryl sulfate discs Int J Pharm 1991;75:45-54.
51. Hanson LH, Stevens DA. Comparison of antifungal activity of amphotericin B deoxycholate with that of amphotericin B cholesteryl sulfate colloidal dispersion. Antimicrob Agents Chemother 1992;36:486-8.
52. Wang LH, Fielding RM, Smith PC, et al. Comparative tissue distribution and elimination of amphotericin B colloidal dispersion (Amphocil) and Fungizone after repeated dosing in rats. Pharm Res 1995;12:275-83.
53. Fielding RM, Singer AW, Wang LH, et al Relationship of pharmacokinetics and drug distribution in tissue to increased safety of amphotericin B colloidal dispersion in dogs. Antimicrob Agents Chemother 1992;36:299-307.
54. Clemons KV, Stevens DA. Comparative efficacy of amphotericin B colloidal dispersion and amphotericin B deoxycholate suspension in treatment of murine coccidioidomycosis. Antimicrob Agents Chemother 1991;35: 1829-33.
55. Hostetler JS, Clemons KV, Hanson LHH, Stevens DA Efficacy and safety of amphotericin B colloidal dispersion compared to those of amphotericin B deoxycholate suspension for treatment of disseminated murine cryptococcosis. Antimicrob Agents Chemother 1992;36:2656-60.
56. Allende MC, Lee JW, Francis P, et al. Dose-dependent antifungal activity and nephrotoxicity of amphotericin B colloidal dispersion in experimental pulmonary aspergillosis. Antimicrob Agents Chemother 1994;38:518-22.
57. Walsh TJ, Garrett K, Feurstein E, et al. Therapeutic monitoring of experimental invasive pulmonary aspergillosis by ultrafast computerized tomography: a novel non-invasive method for measuring responses of organism-mediated tissue injury. Antimicrob Agents Chemother 1995;39:1065-9.
58. Patterson T, Miniter P, Dijkstra J, et al. Treatment of experimental invasive aspergillosis with a novel amphotericin B/cholesterol-sulfate complex. J Infect Dis 1989; 159:717-24.
59. Bowden RA, Cays M, Gooley T, et al. Phase I study of amphotericin B colloidal dispersion for the treatment of invasive fungal infections after marrow transplant. J Infect Dis 1996;173:1208-15.
60. Herbrecht R. Safety of amphotericin B colloidal dispersion. Eur J Clin Microbiol Infect Dis 1997;16:74-80.
61. White MH, Anaissie EJ, Kusne S, et al. Amphotericin B colloidal dispersion vs. amphotericin B as therapy for invasive aspergillosis Clin Infect Dis 1997;24:635-42.
62. Adler-Moore JP, Proffitt RT Development, characterization, efficacy and mode of action of AmBisome, a unilamellar liposomal formulation of amphotericin B. J Liposomal Res 1993;3:429-50.
63. Anaissie E, Paetznick V, Proffitt R, et al. Comparison of the in vitro antifungal activity of free and liposomal-encapsulated amphotericin B. Eur J Clin Microbiol Infect Dis 1991;10:665-8.
64. Proffitt RT, Satorius A, Chiang SM, et al Pharmacology and toxicology of a liposomal formulation of amphotericin B (AmBisome) in rodents. J Antimicrob Chemother 1991;28(B Suppl):49-61.
65. Graybill JR, Bocanegra R Liposomal amphotericin B therapy of murine histoplasmosis. Antimicrob Agents Chemother 1995;39:1885-7.
66. Albert MM, Adams K, Luther MJ, et al. Efficacy of AmBisome in murine coccidioidomycosis. J Med Vet Mycol 1994;32:467-71.
67. Allen SD, Sorensen KN, Nejdl MJ, et al. Prophylactic efficacy of aerosolized liposomal (AmBisome) and non-liposomal (Fungizone) amphotericin B in murine pulmonary aspergillosis. J Antimicrob Chemother 1994;34: 1001-13.
68. Lee JW, Amantea MA, Francis PA, et al Pharmacokinetics and safety of a unilamellar liposomal formulation of amphotericin B (AmBisome) in rabbits. Antimicrob Agents Chemother 1994;38:713-8.
69. Boswell GW, Bekersky I, Buell D, et al. Toxicity and pharmacokinetics following single and multiple intravenous administration of a unilamellar vesicle formulation of amphotericin B (AmBisome) in rats. Antimicrob Agents Chemother (in press).
70. Gondal JA, Swartz RP, Rahman A. Therapeutic evaluation of free and liposome-encapsulated amphotericin B in the treatment of systemic candidiasis in mice. Antimicrob Agents Chemother 1989;33:1544-8.
71. Francis P, Lee JW, Hoffman A, et al. Efficacy of unilamellar liposomal amphotericin B in treatment of pulmonary aspergillosis in persistently granulocytopenic rabbits. J Infect Dis 1994;169:356-68
72. Phals S, Shaffner A. Comparison of activity of free and liposomal amphotericin B in vitro and in a model of systemic and localized murine candidiasis. J Infect Dis 1994;169:1057-61.
73. Walsh TJ, Bekersky I, Yeldandi V, et al. Pharmacokinetics of AmBisome in persistently febrile neutropenic patients receiving empirical antifungal therapy [abstract A11]. In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1995 Sep 17-20; San Francisco (CA). Washington (DC): American Society for Microbiology; 1995. p. 13.
74. Heinemann V, Bosse D, Jehn U, et al. Pharmacokinetics of liposomal amphotericin B (AmBisome) in critically ill patients. Antimicrob Agents Chemother 1997;41:1275-80.
75. Meunier F, Prentice HG, Ringden O. Liposomal amphotericin B (AmBisome): safety data from a phase II/III clinical trial. J Antimicrob Chemother 1991;28(B Suppl): 83-91.
76. Ringden O, Meunier F, Tollemar J, et al. Efficacy of amphotericin B encapsulated in liposome (AmBisome) in the treatment of invasive fungal infections in immunocompromised patients. J Antimicrob Chemother 1991, 28(B Suppl):73-82.
77. Mills W, Chopra R, Linch DC, et al. Liposomal amphotericin B in the treatment of fungal infections in neutropenic patients: a single-center experience of 133 episodes in 116 patients. Br J Haematol 1994;86:754-60.
78. Ng TTC, Denning DW. Liposomal amphotericin B (AmBisome) therapy in invasive fungal infections: evaluation of United Kingdom compassionate use data. Arch Intern Med 1995;155:1093-8.
79. Ringden O. Clinical experience with AmBisome with special emphasis on experience with children. Bone Marrow Transplant 1993;12(4 Suppl):149S-150S.
80. Tollemar J, Duraj F, Ericzon BG. Liposomal amphotericin B treatment in a 9-month-old liver recipient Mycosis 1990;33:251-2.
81. Pasic S, Flannagan L, Cant AJ. Liposomal amphotericin (AmBisome) is safe in bone marrow transplantation for primary immunodeficiency. Bone Marrow Transplant 1997;19:1229-32
82. Lackner H, Schwinger W, Urban C, et al. Liposomal amphotericin B (AmBisome) for the treatment of disseminated fungal infections in two infants of very low birth weight. Pediatrics 1992;89:1259-61.
83. Jarlov JO, Born P, Bruun B. Candida albicans meningitis in a 27 weeks premature infant treated with liposomal amphotericin-B (AmBisome). Scand J Infect Dis 1995;27: 419-20.
84. Dornbusch HJ, Urban CE, Pinter H, et al. Treatment of invasive pulmonary aspergillosis Ln severely neutropenic children with malignant disorders using liposomal amphotericin B (AmBisome), granulocyte colony-stimulating factor, and surgery: report of five cases. Pediatr Hematol Oncol 1995;12:577-86.
85. Tollemar J, Ringden O, Andersson S, et al. Randomized double-blind study of liposomal amphotericin B (AmBisome) prophylaxis of invasive fungal infections in bone marrow transplant recipients. Bone Marrow Transplant 1993;12:577-82.
86. Yardley V, Croft SL. Activity of liposomal amphotericin B against experimental cutaneous leishmaniasis. Antimicrob Agents Chemother 1997;41:752-6.
87. Davidson RN, di Martino L, Gradoni L, et al. Short-course treatment of visceral leishmaniasis with liposomal amphotericin B (AmBisome). Clin Infect Dis 1996;22: 938-43.
88. Kirsh R, Goldstein R, Tarloff J, et al. An emulsion formulation of amphotericin B improves the therapeutic index when treating systemic murine candidiasis. J Infect Dis 1988;138:1065-70
89. Chavanet P, Garry I, Charlier N, et al. Trial of glucose vs. fat emulsion in preparation of amphotericin B for use in HIV infected patients with candidiasis. BMJ 1992;305: 921-5.
90. Caillot D, Casanovas O, Solary E, et al. Efficacy and tolerance of an amphotericin B lipid (Intralipid) emulsion in the treatment of candidemia in neutropenic patients. J Antimicrob Chemother 1993;31:161-9.
91. Moreau P, Milpied N, Fayette N, et al. Reduced renal toxicity and improved clinical tolerance of amphotericin B mixed with intralipid compared with conventional amphotericin B in neutropenic mice. J Antimicrob Chemother 1992;30:535-41.
92. Trissel LA. Amphotericin B does not mix with fat emulsion. Am J Health Syst Pharm 1995;52:1463-4.
93. Persson U, Tennvall GR, Andersson S, et al. Cost-effectiveness analysis of treatment with liposomal amphotericin B vs. conventional amphotericin B in organ or bone marrow transplant recipients with systemic mycosis. PharmacoEconomics 1992;2:500-8.