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Better efficacy and significantly higher global success rate versus the gold standard fluconazole in the treatment of candidaemia*1

Full preview Global success at EOIVT of Ecalta and Fluconzaole

This trial was a pivotal, Phase III, randomised, double-blind, multicentre, multinational non-inferiority study, with a pre-specified two-step statistical analysis for superiority. Primary endpoint was global success (clinical and microbiological) at the end of IV therapy. Clinical success was defined as the resolution of the signs and symptoms of invasive candidiasis and no need for additional systemic antifungal therapy. Microbiological success was defined as the eradication of baseline Candida species (determined by follow-up culture) or presumed eradication if culture data were unavailable for a patient with a successful clinical response.1

  •  Global success rate was significantly higher with anidulafungin versus fluconazole (75.6% vs 60.2%; p=0.02)*1
  • Anidulafungin is more effective than fluconazole in severely ill patients2
    • A secondary analysis showed that the global success rate with anidulafungin was also more effective than fluconazole in patients with critical illness (70.8% vs 54.1%; p=0.03)2

Anidulafungin – effective in patients with deep-tissue candidiasis3

  • In a pooled analysis of data from one randomised, double-blind, comparative study and four open-label, non-comparative studies:3
    • The overall global success rate at EOIVT in patients with deep-tissue candidiasis was 79.1%

*Data at EOIVT for the MITT population, comprising 97% non-neutropenic and 3% neutropenic patients1.
†Critical illness was defined as an Acute Physiology and Chronic Health Evaluation (APACHE) II score ≥15, evidence of severe sepsis and/or patient was in intensive care.2
EOIVT, end of intravenous therapy; IV, intravenous; MITT, modified intention to treat.

References

  1. Reboli AC, et al. N Engl J Med 2007;356:2472-2482.
  2. Kett DH, et al. Critical Care 2011;15:R253.
  3. Aram J, et al. Abstract R691. Presented at the 24th ECCMID 2014.