A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis.

(See the editorial commentary by Darouiche on pages 850–2 and the article by de Wet et al. on pages 842–9)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 in601 patients with endoscopically and microbiologically documented esophageal candidiasis. Patients receivedintravenous anidulafungin (100 mg on day 1, followed by 50 mg per day) or oral fluconazole (200 mg on day1, followed by 100 mg per day) for 7 days beyond resolution of symptoms (range, 14–21 days). At the end oftherapy, the rate of endoscopic success for anidulafungin (242 [97.2%] of 249 treated patients) was found tobe 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 offluconazole; treatment-related adverse events occurred in 9.3% and 12.0% of patients, respectively. Laboratoryparameters were similar between treatment arms. Anidulafungin is as safe and effective as oral fluconazolefor the treatment of esophageal candidiasis, when assessed at the completion of therapy.