AMPHOTERICIN-B LIPID COMPLEX FOR INVASIVE FUNGAL-INFECTIONS - ANALYSIS OF SAFETY AND EFFICACY IN 556 CASES

The safety and antifungal efficacy of amphotericin B lipid complex (AB LC) were evaluated in 556 cases of invasive fungal infection treated t hrough an open-label, single-patient, emergency-use study of patients who were refractory to or intolerant of conventional antifungal therap y, All 556 treatment episodes were evaluable for safety. During the co urse of ABLC therapy, serum creatinine levels significantly decreased from baseline (P < .02), Among 162 patients with serum creatinine valu es greater than or equal to 2.5 mg/dL at the start of ABLC therapy (ba seline), the mean serum creatinine value decreased significantly from the first week through the sixth week (P less than or equal to .0003), Among the 291 mycologically confirmed cases evaluable for therapeutic response, there was a complete or partial response to ABLC in 167 (57 %), including 42% (55) of 130 cases of aspergillosis, 67% (28) of 42 c ases of disseminated candidiasis, 71% (17) of 24 cases of zygomycosis, and 82% (9) of 11 cases of fusariosis, Response rates varied accordin g to the pattern of invasive fungal infection, underlying condition, a nd reason for enrollment (intolerance versus progressive infection), T hese findings support the use of ABLC in the treatment of invasive fun gal infections in patients who are intolerant of or refractory to conv entional antifungal therapy.