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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. L Amph/ABLC Collaborative Study Group.

Abstract
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.
AuthorsJ R Wingard, M H White, E Anaissie, J Raffalli, J Goodman, A Arrieta, L Amph/ABLC Collaborative Study Group
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 31 Issue 5 Pg. 1155-63 (Nov 2000) ISSN: 1058-4838 [Print] United States
PMID11073745 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antifungal Agents
  • Drug Carriers
  • Liposomes
  • Amphotericin B
Topics
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amphotericin B (adverse effects, therapeutic use)
  • Antifungal Agents (adverse effects, therapeutic use)
  • Child
  • Child, Preschool
  • Chills (chemically induced)
  • Double-Blind Method
  • Drug Carriers
  • Female
  • Fever (chemically induced)
  • Humans
  • Infusions, Intravenous
  • Liposomes
  • Male
  • Middle Aged
  • Mycoses (prevention & control)
  • Nausea (chemically induced)
  • Neutropenia (drug therapy, mortality)
  • Survival Rate
  • Vomiting (chemically induced)

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