THE SAFETY AND EFFICACY OF AMPHOTERICIN-B COLLOIDAL DISPERSION IN THETREATMENT OF INVASIVE MYCOSES

Amphotericin B colloidal dispersion (ABCD), a novel formulation of amp hotericin B and cholesteryl sulfate in a 1:1 ratio, was developed to r educe the toxicity of amphotericin B yet retain its antifungal efficac y. 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 myc oses. All patients had responded incompletely to at least 7 days' trea tment with conventional amphotericin B (CAB), had experienced CAB-indu ced nephrotoxic effects, had preexisting renal impairment, or had expe rienced other CAB-related, treatment-limiting toxic effects. The clini cal response to ABCD could be evaluated in 97 patients. Complete clini cal response or improvement was noted in 48 (49%) of them after a mean treatment duration of 18.5 days. Al 168 enrolled patients were evalua ted with regard to safety of the treatment. Even at daily doses as hig h as 6 mg/kg, and mean and median cumulative doses of 4.0 g and 2.4 g, respectively, ABCD had little renal toxicity: the mean change in seru m level of creatinine from baseline to final value was -0.02 mg/dL. Hy pokalemia developed in eight patients (5%). This study provides prelim inary evidence that ABCD is effective in treating invasive mycoses and lacks the dose-limiting nephrotoxicity of CAB.