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  • Poster presentation
  • Open Access

Anidulafungin for candidemia/invasive candidiasis in non-neutropenic ICU patients

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Critical Care201115 (Suppl 1) :P240

https://doi.org/10.1186/cc9660

  • Published:

Keywords

  • Candidiasis
  • Azole
  • Global Response
  • Anidulafungin
  • Sofa Score

Introduction

A recent study found anidulafungin (ANI) safe and effective for candidemia/invasive candidiasis (C/IC) in selected populations of ICU patients [1]. A post hoc analysis of this study was performed to evaluate the efficacy of ANI in the same populations, but in non-neutropenic C/IC patients only.

Methods

A prospective, open label, multinational, phase 3b study in adult ICU patients (APACHE II score <25) with ≥1 of the following: post-abdominal surgery; age ≥65 years; renal/hepatic insufficiency; solid organ transplant; neutropenia; and/or solid tumor. C/IC was confirmed from 96 hours before to 48 hours after the start of study treatment. Patients received i.v. ANI (200 mg on day 1, 100 mg/day thereafter) for ≥10 days, with optional oral azole step-down therapy, for a total treatment duration of 14 to 56 days. Primary efficacy endpoint was global response at end of all therapy (EOT) in the evaluable modified intent-to-treat (eMITT) population; that is, excluding patients with missing/unknown responses. For the present analysis, all patients with neutropenia were excluded.

Results

The total MITT population (that is, confirmed C/IC and ≥1 dose of ANI) included 170 patients, 157 (92.4%) of whom were non-neutropenic. In these patients at baseline, 69.4% had candidemia, mean APACHE II score was 16.3 (range 4 to 26) and mean SOFA score 7.4 (range 0 to 20). In non-neutropenic eMITT patients, global response at EOT was 71.1% (95% CI = 62.9, 78.4). At the end of i.v. therapy, 2 weeks post-EOT and 6 weeks post-EOT the global response was 72.4%, 61.2% and 52.0%, respectively. When missing/unknown responses were included and classed as failures, global success was 64.3% at EOT. The 90-day Kaplan-Meier survival estimate was 55.0% (95% CI = 47.2, 62.9). Among all non-neutropenic patients with ≥1 dose of ANI, treatment-related (due to ANI and/or azole) AEs and serious AEs occurred in 29/201 (14.4%) and 3/201 (1.5%) of patients, respectively. The most common treatment-related AE was erythema in four patients (2.0%). Other treatment-related AEs occurred in ≤1.5% of non-neutropenic patients.

Conclusions

ANI was effective and safe for the treatment of C/IC in selected populations of non-neutropenic ICU patients.

Authors’ Affiliations

(1)
Charité University Hospital, Berlin, Germany
(2)
Hospital São João, Porto, Portugal
(3)
University Hospital Leuven, Belgium
(4)
University Hospital Královské Vinohrady, Prague, Czech Republic
(5)
University Hospital Sf Spiridon, Iaśi, Romania
(6)
University Hospital A Gemelli, Rome, Italy
(7)
University Hospital Pisa, Italy
(8)
Hospital Bichat Claude Bernard, Paris, France
(9)
King's College Hospital, London, UK
(10)
University Hospital Attikon, Haidari, Greece
(11)
Hospital Son Llatzer, Palma de Mallorca, Spain
(12)
Pfizer, Sandwich, UK
(13)
Pfizer, Paris, France

References

  1. Paiva JA, et al.: Anidulafungin (ANID) for treatment of candidemia/invasive candidiasis (C/IC) in selected intensive care unit (ICU) populations. Crit Care Med 2010,38(12 Suppl):297.Google Scholar

Copyright

© Ruhnke et al. 2011

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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