Comparison of the toxicity of amphotericin B in 5% dextrose with that of amphotericin B in fat emulsion in a randomized trial with cancer patients

A multicentric randomized trial was undertaken to compare the toxicity of a mphotericin B in 5% dextrose with that of amphotericin B in a fat emulsion (Intralipid) in cancer patients. Group 1 (n = 33) received amphotericin B d iluted in 5% dextrose with premedication consisting of promethazine plus an antipyretic. Group 2 (n = 28) received amphotericin B diluted in 20% Intra lipid without premedication. Amphotericin B was infused daily at a dose of 1 mg/kg of body weight over a 1-h period to members of both groups for empi rical antifungal therapy (in neutropenic patients) or for the treatment of documented fungal infections. The majority of patients (80%) received empir ical amphotericin B treatment. The two groups were comparable with regard t o age, gender, underlying disease, and the following baseline characteristi cs: use of other nephrotoxic drugs and serum levels of potassium and creati nine, The median cumulative doses of amphotericin B were 240 mg in group 1 and 245 mg in group 2 (P = 0.73), Acute adverse events occurred in 88% of p atients in group 1 and in 71% of those in group 2 (P = 0.11), Forty percent of the infusions in group I were associated with fever, compared to 23% in group 2 (P < 0.0001). In addition, patients in group 2 required less meper idine for the control of acute adverse events (P = 0.008), and fewer member s of this group presented with hypokalemia (P = 0.004) or rigors (P < 0.000 1). There was no difference in the proportions of patients with nephrotoxic ity (P 0.44). The success rates of empirical antifungal treatment were simi lar in the two groups (P = 0.9). Amphotericin B diluted in a lipid emulsion seems to be associated with a smaller number of acute adverse events and f ewer cases of hypokalemia than amphotericin B diluted in 5% dextrose.