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Previous Volume 356:2472-2482 June 14, 2007 Number 24 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Sobel, J. D. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

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] ).

Source Information

From the University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School and Cooper University Hospital, Camden, NJ (A.C.R.); McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (C.R.); University of Alabama at Birmingham, Birmingham (P.G.P.); University of Mississippi, Jackson (S.W.C.); Miller School of Medicine at the University of Miami, Miami (D.H.K.); University of Toronto, University Health Network, Toronto (D.K.); University of Rochester, Rochester, NY (R.B.); Vicuron Pharmaceuticals, King of Prussia, PA (M.W., B.P.G., J.S., D.S.K.); the National Cancer Institute, Bethesda, MD (T.J.W.).

Address reprint requests to Dr. Reboli at the Division of Infectious Diseases, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, Cooper University Hospital, Education and Research Bldg., 401 Haddon Ave., Rm. 270, Camden, NJ 08103, or at reboli-annette{at}cooperhealth.edu.

Full Text of this Article

Related Letters:

Anidulafungin and Fluconazole for Candidiasis
Aberegg S. K., O'Brien J. M. Jr., Nir-Paz R., Moses A. E., Reboli A. C., Wible M., Walsh T. J.
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N Engl J Med 2007; 357:1347-1348, Sep 27, 2007. Correspondence

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