The Safety and Efficacy of Amphotericin B Colloidal Dispersion in the Treatment of Invasive Mycoses

Amphotericin B colloidal dispersion (ABCD), a novel formulation of amphotericin B and cholesteryl sulfate in a 1:1 ratio, was developed to reduce the toxicity of amphotericin B yet retain its antifungal efficacy. In an open-label trial, ABCD at dosages as high as 6 mg/(kg·d) was administered to 168...

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Bibliographic Details
Published in:Clinical infectious diseases 1995-11, Vol.21 (5), p.1145-1153
Main Authors: Oppenheim, Beryl A., Herbrecht, Raoul, Kusne, Shimon
Format: Article
Language:English
Subjects:
Adult
AIDS
Amphotericin B - administration & dosage
Amphotericin B - adverse effects
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antifungal agents
Antifungals
Aspergillosis
Aspergillus
Biological and medical sciences
Candidiasis
Clinical Articles
Colloids
Creatinine - blood
Cryptococcosis
Dosage
Female
Fungal infections
Humans
Hypokalemia - chemically induced
Infections
Kidney - drug effects
Male
Medical sciences
Mycoses - drug therapy
Nephrotoxicity
Pharmacology. Drug treatments
Safety
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Summary:Amphotericin B colloidal dispersion (ABCD), a novel formulation of amphotericin B and cholesteryl sulfate in a 1:1 ratio, was developed to reduce the toxicity of amphotericin B yet retain its antifungal efficacy. In an open-label trial, ABCD at dosages as high as 6 mg/(kg·d) was administered to 168 patients with documented or presumed systemic mycoses. All patients had responded incompletely to at least 7 days' treatment with conventional amphotericin B (CAB), had experienced CAB-induced nephrotoxic effects, had preexisting renal impairment, or had experienced other CABrelated, treatment-limiting toxic effects. The clinical response to ABCD could be evaluated in 97 patients. Complete clinical response or improvement was noted in 48 (49%) of them after a mean treatment duration of 18.5 days. All 168 enrolled patients were evaluated with regard to safety of the treatment. Even at daily doses as high as 6 mglkg, and mean and median cumulative doses of 4.0 g and 2.4 g, respectively, ABCD had little renal toxicity: the mean change in serum level of creatinine from baseline to final value was −0.02 mg/dL. Hypokalemia developed in eight patients (5%). This study provides preliminary evidence that ABCD is effective in treating invasive mycoses and lacks the dose-limiting nephrotoxicity of CAB.
ISSN:1058-4838
1537-6591
DOI:10.1093/clinids/21.5.1145