659. Does Weight Based Dosing of Fluconazole Influence the Outcome for Candidemia and Other Forms of Invasive Candidiasis (C/IC): A Retrospective Analysis of Data Collected in the Anidulafungin Versus Fluconazole Trial for C/IC
Session: Abstracts: Mycology
Friday, October 22, 2010
Background: As many as 55% of fluconazole doses administered to hospitalized patients are < 6 mg/kg.  Inadequate initial dosing has been cited as a risk factor for overall hospital mortality and may be exacerbated by rising rates of obesity.  The impact of weight in relation to fluconazole dose and therapeutic efficacy for C/IC has not been studied.

Methods: We retrospectively examined prospectively collected data from a randomized, double blind, phase 3 trial of anidulafungin versus fluconazole for C/IC.  The modified intention-to-treat population of the fluconazole arm of the study was the study population.  Each patient’s weight based dose for fluconazole (mg/kg) was calculated and study efficacy results at various endpoints were reported for two groups, those with doses < 6 mg/kg and doses > 6 mg/kg.  Univariate analysis was performed using Mann-Whitney test for quantitative variables and Chi-squared test or Fisher’s exact test for categorical variables. Logistic regression and classification trees (CART) were used to identify demographic and clinical characteristics associated with treatment success.

Results: 120 subjects were included in the study with 33% (n =40) receiving a dose >6 mg/kg.  At the end of IV therapy, 31 successes and 49  failures were noted in the < 6 mg/kg dosing cohort and 14 successes and 26  failures in the > 6 mg/kg cohort (p = 0.69).  Similar results were seen at all secondary endpoints.  By logistic regression only APACHE II score was a predictor of failure (p = 0.01) in patients with C/IC.

Conclusion: Guideline-recommended, weight-based dosing of fluconazole (6mg/kg) was not independently predictive of patient outcomes.  These findings suggest clinicians can use fixed doses of fluconazole for C/IC, but should be cautious using fluconazole in critically ill patients.

Subject Category: M. Mycology including clinical and basic studies of fungal infections

Trent G. Towne, Pharm.D , Department of Pharmacy Practice / Pharmacy Administration, Philadelphia College of Pharmacy, Philadelphia, PA
Laura Pontiggia, Ph.D. , Department of Mathmatics, Physics and Statistics, University of the Sciences In Philadelphia, Philadelphia, PA
Annette Reboli, MD , Cooper University Hospital, Camden, NJ


T. G. Towne, None

L. Pontiggia, None

A. Reboli, Yes
Pfizer: Consultant, Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium
Merck: Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium

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