Journal Article

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

John R. Wingard, Mary H. White, Elias Anaissie, John Raffalli, Jesse Goodman and Antonio Arrieta

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 31, issue 5, pages 1155-1163
Published in print November 2000 | ISSN: 1058-4838
Published online November 2000 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/317451
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

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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.

Journal Article.  7118 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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