A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis.
Anidulafungin is a novel antifungal agent of the echinocandin class. This randomized, double-blind, double-dummy study compared the efficacy and safety of intravenous anidulafungin to that of oral fluconazole in 601 patients with endoscopically and microbiologically documented esophageal candidiasis. Patients received intravenous anidulafungin (100 mg on day 1, followed by 50 mg per day) or oral fluconazole (200 mg on day 1, followed by 100 mg per day) for 7 days beyond resolution of symptoms (range, 14-21 days). At the end of therapy, the rate of endoscopic success for anidulafungin (242 [97.2%] of 249 treated patients) was found to be statistically noninferior to that for fluconazole (252 [98.8%] of 255 treated patients; treatment difference, -1.6%; 95% confidence interval, -4.1 to 0.8). The safety profile of anidulafungin was similar to that of fluconazole; treatment-related adverse events occurred in 9.3% and 12.0% of patients, respectively. Laboratory parameters were similar between treatment arms. Anidulafungin is as safe and effective as oral fluconazole for the treatment of esophageal candidiasis, when assessed at the completion of therapy.
Vicuron Pharmaceuticals, King of Prussia, Pennsylvania 19406, USA. dkrause@vicuron.com
David S
DS
Krause
A E
AE
Simjee
Christo
C
van Rensburg
Johann
J
Viljoen
Thomas J
TJ
Walsh
Beth P
BP
Goldstein
Michele
M
Wible
Timothy
T
Henkel
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000077612:Anidulafungin; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002177:Candidiasis / Q000188:drug therapy*; D004311:Double-Blind Method; D054714:Echinocandins; D004935:Esophageal Diseases / Q000188:drug therapy / Q000382:microbiology*; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage / Q000627:therapeutic use*
D000935:Antifungal Agents; D054714:Echinocandins; D010456:Peptides, Cyclic; D015725:Fluconazole; D000077612:Anidulafungin