Anidulafungin compared with fluconazole in severely ill patients with candidemia and other forms of invasive candidiasis: Support for the 2009 IDSA treatment guidelines for candidiasis.
Crit Care. 2011 Oct 25;15(5):R253
Authors: Kett DH, Shorr AF, Reboli AC, Reisman AL, Biswas P, Schlamm HT
Abstract
ABSTRACT: INTRODUCTION: During the past decade the incidence of Candida infections in hospitalized patients has increased, with fluconazole being the most commonly prescribed systemic antifungal agent for these infections. However, the 2009 Infectious Diseases Society of America (IDSA) candidiasis guidelines, which recommend an echinocandin for the treatment of candidemia/invasive candidiasis in patients who are considered to be 'moderately severe or severely' ill. To validate these guidelines, clinical trial data were reviewed, METHODS: A secondary analysis of data from a previously published prospective, randomized, double-blind clinical trial that compared anidulafungin to fluconazole for the treatment of invasive candidiasis and candidemia was performed. Baseline data were reviewed, which had been prospectively collected in a randomized. Patients with critical illness were identified at study entry using the following criteria: Acute Physiology and Chronic Health Evaluation (APACHE) II score of [greater than or equal to]15, evidence of severe sepsis (sepsis and [greater than or equal to]1 end-organ dysfunction) present, and/or patient was in intensive care. Global response rates were compared at the end of intravenous study treatment (the primary endpoint of the original study) and all-cause mortality at 14 and 28 days from study entry in this group. RESULTS: 163/245 (66.5%) patients fulfilled at least one criteria for critical illness (anidulafungin, n = 89; fluconazole, n = 74). There were no significant differences in baseline characteristics between the two treatment groups. The global response rate was 70.8% for anidulafungin and 54.1% for fluconazole (P = 0.03; 95% confidence interval [CI]: 2.0, 31.5); all-cause mortality was 10.1% versus 20.3% at 14 days (P = 0.08; 95% CI -0.9, 21.3) and was 20.2% versus 24.3% at 28 days (P = 0.57; 95% CI -8.8, 17.0) for anidulafungin and fluconazole, respectively. CONCLUSIONS: In this post-hoc analysis, anidulafungin was more effective than fluconazole for treatment of severely ill patients with candidemia, thus supporting the 2009 IDSA guidelines. Trial registration: Clinicaltrials.gov NCT00058682.
PMID: 22026929 [PubMed - as supplied by publisher]