Anidulafungin versus fluconazole for invasive candidiasis

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Anidulafungin versus fluconazole for invasive candidiasis.

New England Journal of Medicine*

Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D,

Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ;

Anidulafungin Study Group.

Comment in:

ACP J Club. 2008 Jan-Feb;148(1):15.

N Engl J Med. 2007 Jun 14;356(24):2525-6.

N Engl J Med. 2007 Sep 27;357(13):1347-8; author reply 1348.

N Engl J Med. 2007 Sep 27;357(13):1347; author reply 1348.

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University of Medicine and Dentistry of New Jersey- Wood

Medical School and University Hospital, Camden, NJ

08103, USA. reboli-annette@...

BACKGROUND: Anidulafungin, a new echinocandin, has potent activity

against candida species. We compared anidulafungin with fluconazole

in a randomized, double-blind, noninferiority trial of treatment for

invasive candidiasis. METHODS: Adults with invasive candidiasis were

randomly assigned to receive either intravenous anidulafungin or

intravenous fluconazole. All patients could receive oral fluconazole

after 10 days of intravenous therapy. The primary efficacy analysis

assessed the global response (clinical and microbiologic) at the end

of intravenous therapy in patients who had a positive baseline

culture. Efficacy was also assessed at other time points. RESULTS:

Eighty-nine percent of the 245 patients in the primary analysis had

candidemia only. Candida albicans was isolated in 62% of the 245

patients. In vitro fluconazole resistance was infrequent. Most of

the patients (97%) did not have neutropenia. At the end of

intravenous therapy, treatment was successful in 75.6% of patients

treated with anidulafungin, as compared with 60.2% of those treated

with fluconazole (difference, 15.4 percentage points; 95% confidence

interval [CI], 3.9 to 27.0). The results were similar for other

efficacy end points. The statistical analyses failed to show

a " center effect " ; when data from the site enrolling the largest

number of patients were removed, success rates at the end of

intravenous therapy were 73.2% in the anidulafungin group and 61.1%

in the fluconazole group (difference, 12.1 percentage points; 95%

CI, -1.1 to 25.3). The frequency and types of adverse events were

similar in the two groups. The rate of death from all causes was 31%

in the fluconazole group and 23% in the anidulafungin group

(P=0.13). CONCLUSIONS: Anidulafungin was shown to be noninferior to

fluconazole in the treatment of invasive candidiasis.

(ClinicalTrials.gov number, NCT00056368 [ClinicalTrials.gov]).

Copyright 2007 Massachusetts Medical Society.

Publication Types:

Comparative Study

Multicenter Study

Randomized Controlled Trial

Research Support, Non-U.S. Gov't

PMID: 17568028 [PubMed - indexed for MEDLINE]