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, Timothy Henkel

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)770-775
Number of pages6
JournalClinical Infectious Diseases
Volume39
Issue number6
DOIs
StatePublished - Sep 15 2004
Externally publishedYes

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anidulafungin
Fluconazole
Candidiasis
Therapeutics
Echinocandins
Safety
Antifungal Agents
Double-Blind Method
Confidence Intervals

ASJC Scopus subject areas

  • Immunology

Cite this

Krause, D. S., Simjee, A. E., Van Rensburg, C., Viljoen, J., Walsh, T. J., Goldstein, B. P., ... Henkel, T. (2004). A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis. Clinical Infectious Diseases, 39(6), 770-775. https://doi.org/10.1086/423378

A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis. / Krause, David S.; Simjee, A. E.; Van Rensburg, Christo; Viljoen, Johann; Walsh, Thomas J.; Goldstein, Beth P.; Wible, Michele; Henkel, Timothy.

In: Clinical Infectious Diseases, Vol. 39, No. 6, 15.09.2004, p. 770-775.

Research output: Contribution to journalArticle

Krause, DS, Simjee, AE, Van Rensburg, C, Viljoen, J, Walsh, TJ, Goldstein, BP, Wible, M & Henkel, T 2004, 'A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis', Clinical Infectious Diseases, vol. 39, no. 6, pp. 770-775. https://doi.org/10.1086/423378
Krause, David S. ; Simjee, A. E. ; Van Rensburg, Christo ; Viljoen, Johann ; Walsh, Thomas J. ; Goldstein, Beth P. ; Wible, Michele ; Henkel, Timothy. / A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis. In: Clinical Infectious Diseases. 2004 ; Vol. 39, No. 6. pp. 770-775.
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