Liposomal amphotericin B (AmBisome): safety data from a phase II/III clinical trial

Abstract

AmBisome is commmercially available preparation of amphotericin B incorporated in small unilamellar lipsomes. The analysis of safely data provided in a multicentre compassionate phase II/III study evaluating 133 episodes of therapy with AmBisome in patients with server underlying dieses is very encouraging. Rapid (30–60 min) administration of a high daily does of AmBisome is feasible without the well known side effects observed with the conventional formulation of amphotericin B (Fungizone). Although eleven of 71 patients with initially normal serum creatinine concentration showed increased values after AmBisome therapy, 17 patients among 50 with initially high creatinine concentrations recovered normal renal function during AmBisome treatment. Hypokalaemia was observed 24 episodes of treatment (18%). Increases in serum glutamyl oxaloacetic transaminase and alkaline phosphatase were also quit common in this selected population with severe underlying disease and the contribution of AmBisome appears a safe alrnative to conventional amphotericin B, and its eficacy should be further investigated.