Journal Article

A Randomized, Double-Blind Trial of Anidulafungin versus Fluconazole for the Treatment of Esophageal Candidiasis

David S. Krause, A. E. Simjee, Christo van Rensburg, Johann Viljoen, Thomas J. Walsh, Beth P. Goldstein, Michele Wible and Timothy Henkel

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 39, issue 6, pages 770-775
Published in print September 2004 | ISSN: 1058-4838
Published online September 2004 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/423378
A Randomized, Double-Blind Trial of Anidulafungin versus Fluconazole for the Treatment of Esophageal Candidiasis

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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.

Journal Article.  3856 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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