A RANDOMIZED, DOUBLE-BLIND COMPARATIVE TRIAL EVALUATING THE SAFETY OF LIPOSOMAL AMPHOTERICIN B VERSUS AMPHOTERICIN B LIPID COMPLEX IN THE EMPIRICAL TREATMENT OF FEBRILE NEUTROPENIA

A RANDOMIZED, DOUBLE-BLIND COMPARATIVE TRIAL EVALUATING THE SAFETY OF LIPOSOMAL AMPHOTERICIN B VERSUS AMPHOTERICIN B LIPID COMPLEX IN THE EMPIRICAL TREATMENT OF FEBRILE NEUTROPENIA [Wingard JR, et al. CID 2000;31:1155]: The authors present a comparative trial of liposomal amphotericin B in two doses (3 mg/kg/day and 5 mg/kg/day) and amphotericin B colloidal dispersion (ABLC) (5 mg/kd/day) in 244 patients with febrile neutropenia. The results showed that liposomal amphotericin B (AmBisome) was less toxic in terms of infusion-related toxicity and nephrotoxicity, and the two drugs were equally effective in terms of efficacy. Results are shown in the table below: Table: Amphotericin B lipid preparations compared in 244 patients with febrile NeutropeniaComment. The results of this study are quite straightforward in demonstrating that AmBisome is less toxic than Amphotec, although the two drugs appear to be equally effective in terms of response rates. The major concern with both drugs is cost. The AWP for Amphotec in the dose used in this study is $560/day; for AmBisome it is $940/day for the low dose and $1316/day for the high dose. Jack Bennett from the NIH wrote the accompanying editorial [CID 2000;51:1164] in which he noted that physicians have been forced to choose amphotericin B preparations on the basis of either price or adverse reactions because there are no adequate studies comparing efficacy of any two amphotericin B formulations in proven mycotic infections. The dilemma posed here is that it is unclear that amphotericin B is needed at all. J. Wingard and colleagues conclude that AmBisome has a superior safety profile compared to Amphotec; Dr. Bennett concludes that decisions about these drugs has been moved “from the bedside to the board room” due to the high cost.