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
In this double-blind study to compare safety of 2 lipid formulations of amphotericin B, neutropenic patients with unresolved fever after 3 days of antibacterial therapy were randomized (1:1:1) to receive amphotericin B lipid complex (ABLC) at a dose of 5 mg/kg/d (n = 78), liposomal amphotericin B (L Amph) at a dose of 3 mg/kg/d (n = 85), or L Amph at a dose of 5 mg/kg/d (n = 81). L Amph (3 mg/kg/d and 5 mg/kg/d) had lower rates of fever (23.5% and 19.8% vs. 57.7% on day 1; P < .001), chills/rigors (18.8% and 23.5% vs. 79.5% on day 1; P <.001), nephrotoxicity (14.1% and 14.8% vs. 42.3%; P<.01), and toxicity-related discontinuations of therapy (12.9% and 12.3% vs. 32.1%; P = .004). After day 1, infusional reactions were less frequent with ABLC, but chills/rigors were still higher (21.0% and 24.3% vs. 50,7%; P < .001). Therapeutic success was similar in all 3 groups.
Wingard, JR; White, MH; Anaissie, E; Raffalli, J; Goodman, J; Arrieta, A; Albano, E; Bodensteiner, D; Broun, ER; Cagnoni, P; Greenberg, R; Hiemenz, J; Holcenberg, JS; Sepkowitz, K; Kreissman, S; Longo, WR; Roy, V; Uberti, J; Vesole, D; Buell, D; Thuma, N; Roloff, B; Hodosh, E
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