CA Sable, B-Y Nguyen, JA Chodakewitz, M DeStefano, RS Berman, and Ml DiNubile


CA is the first member of the novel echinocandin class of and fungal drugs to be submitted to the FDA. Accordingly, its safety profile in Phase II/III trials to date is particularly important to view. CA was administered u a one-hour intravenous infusion of 35 (n=34), 50 (n.244) or 70 mg (n=71) dissolved in 0.9% saline solution as treatment of Candida (n=277; 79%) or Aspergillus (n=72; 21%) infections. The median duration of therapy was between 8-14 days, but patients (7°/.) received at least 50 mg/d for >4 wk. The tables contrast the frequencies of selected clinical and laboratory adverse events (AEs) in the 3 randomized trials of CA vs. amphotericin B desoxycholate (A0 0.5 mg/kg/d) or fuconazole (Flu 200 mg/d) for the treatment of mucosal Candida infections. The majority of patients enrolled in these studies of candidiasis were men with advanced HIV infection. Fever was judged to be related to CA in 23% of cases in the two controlled foals using As as the comparator. However, in the direct comparative study of CA vs. Flu, drug-related fever developed in only 4% of CA recipients, a rate comparable to that seen with Flu. CA was occasionally associated with symptoms such as rash and facial swelling, which could potentially have been mediated through endogenous hi-mine release; a reversible anaphylactic reaction occurred during the initial CA infusion in one patient. The most frequent drug-related laboratory AEs with CA were increased serum ALT, AST and alkaline phosphatase levels. Most of the increases in hepatic enzymes were

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Full conference title: 

Focus on Fungal Infections 11, March 14-16 2001
    • Focus on Fungal Infection 11 (2001)