Assessment of nephrotoxicity in patients receiving amphotericin B lipid complex: a pharmacosurveillance study in Spain.

This study assessed the risk of haematological, renal and hepatic toxicity associated with amphotericin B lipid complex (ABLC; Abelcet) in a multicentre, open-label, non-comparative study of 93 patients from 17 different hospitals who received ABLC because of proven or suspected systemic fungal infection or leishmaniasis. Most (66%) patients had onco-haematological diseases. Optimum treatment with ABLC comprised a slow (2-h) infusion dose of 5 mg/kg/day for a minimum period of 14 days. Biochemical and haematological parameters were measured pre-, during and post-treatment. In the overall patient group, the mean serum creatinine concentration was similar pre- and post-study (1.00 +/- 1.14 mg/dL vs. 1.20 +/- 1.19 mg/dL; p > 0.05). There were no significant changes pre- and post-treatment in concentrations of haemoglobin, potassium, transaminases and bilirubin. There was no significant correlation between the dose administered and the concentrations of serum creatinine (Spearmann 0.22). There was no greater nephrotoxicity in the patients with previous renal failure, or in those who had received amphotericin B previously. There were serious adverse events in five patients, but other alternative causes that could explain these events were present in three of these patients. Fevers or chills were experienced by 23% of the patients during the ABLC infusion, but only in one case did this necessitate the suspension of treatment. It was concluded that ABLC is a drug with low nephrotoxicity, even when administered to patients with pre-existing renal insufficiency. Adverse events were generally slight or moderate, and were managed easily with appropriate pre-medication.