A study was conducted to compare the renal effects of amphotericin B l
ipid complex (ABLC), a lipid formulation of the widely used antifungal
medication, with conventional amphotericin B (AmB) in the treatment o
f serious fungal infections, including invasive candidiasis, cryptococ
cal meningitis, and aspergillosis. The clinical experience of ABLC inc
ludes two types of open-label studies: randomized comparative (ABLC 5
mg/kg/d compared with AmB 0.6 to 1 mg/kg) and emergency use. In the co
mparative studies, changes in serum creatinine were evaluated three wa
ys: doubling of the baseline value, an increase from less than or equa
l to 1.5 mg/dL at baseline to greater than or equal to 1.5 mg/dL, and
an increase from less than or equal to 1.5 mg/dL at baseline to greate
r than or equal to 2.0 mg/dL. More patients in the AmB group reached t
hese end points than in the ABLC group (P less than or equal to 0.007)
, and the time needed to reach each of these end points was significan
tly shorter for the AmB group (P less than or equal to 0.02). Increase
d serum creatinine was reported as an adverse event more frequently by
patients receiving AmB than by patients receiving ABLC. In the emerge
ncy use study, a steady and statistically significant decrease in seru
m creatinine was observed among patients who started ABLC treatment wi
th serum creatinine greater than 2.5 mg/dL due to prior AmB treatment.
ABLC offers the physician a valuable, less nephrotoxic alternative to
AmB for the treatment of patients with severe, invasive fungal infect
ions, (C) 1998 by the National Kidney Foundation, Inc.