Renal sparing by amphotericin B colloidal dispersion: clinical experience in 572 patients.
Data from five clinical trials of amphotericin B colloidal dispersion (ABCD) in the treatment of invasive mycoses were pooled to analyze the renal sparing effects of ABCD. Serum creatinine levels at baseline and either during or at end of treatment were available for 499 of 572 patients (87.2%). The median cumulative dose of ABCD administered to the 499 evaluable patients was 4,050 (range: 30-74,250) mg, and the median duration of treatment was 18 (range: 1-407) days. For the entire group of evaluable patients, the median change in serum creatinine during treatment with ABCD was -0. 1 mg/dl; for the subgroups of patients enrolled in the trials because of amphotericin B toxicity or preexisting renal impairment, the median changes in serum creatinine were -0.3 and -0.2 mg/dl, respectively. There was no trend of increasing serum creatinine with increasing cumulative dose of ABCD (correlation coefficient = -0. 016). ABCD was prematurely discontinued in 19 of 572 patients (3.3%) because of elevated serum creatinine levels. Unlike conventional amphotericin B, ABCD is not associated with dose-dependent nephrotoxicity.
ALZA Corporation, Menlo Park, CA 94025, USA.
M
M
Gurwith
R
R
Mamelok
L
L
Pietrelli
C
C
Du Mond
D000666:Amphotericin B / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000494:pharmacology*; D002986:Clinical Trials as Topic; D003404:Creatinine / Q000097:blood; D003840:Deoxycholic Acid / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D008297:Male; D016896:Treatment Outcome
D000935:Antifungal Agents; D004338:Drug Combinations; D003840:Deoxycholic Acid; D000666:Amphotericin B; C059765:amphotericin B, deoxycholate drug combination; D003404:Creatinine