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Int. J. Antimicrob. Agents · Dec 2012
Multicenter StudyEfficacy and safety of anidulafungin in elderly, critically ill patients with invasive Candida infections: a post hoc analysis.
- George Dimopoulos, José-Artur Paiva, Wouter Meersseman, Jan Pachl, Ioana Grigoras, Gabriele Sganga, Philippe Montravers, Georg Auzinger, Marcio Borges Sá, Paul J Miller, Tomas Marček, Michal Kantecki, and Markus Ruhnke.
- University Hospital Attikon, Athens, Greece. gdimop@med.uoa.gr
- Int. J. Antimicrob. Agents. 2012 Dec 1; 40 (6): 521-6.
AbstractPost hoc analysis of a non-comparative, prospective, multicentre, phase IIIb study was performed to compare efficacy and safety of anidulafungin in elderly (≥65 years) versus non-elderly (<65 years) Intensive Care Unit (ICU) patients with candidaemia/invasive candidiasis (C/IC). Adult ICU patients with confirmed C/IC meeting ≥1 of the following criteria were enrolled: post-abdominal surgery; solid tumour; renal/hepatic insufficiency; solid organ transplantation; neutropenia; age ≥65 years. Patients received anidulafungin (200 mg on Day 1, 100 mg/day thereafter) for ≥10 days followed by optional azole step-down therapy for a total treatment duration of 14-56 days. The primary efficacy endpoint was global (clinical and microbiological) response at the end of all therapy (EOT). Primary efficacy analysis was performed in the modified intent-to-treat (mITT) population (n=170), excluding unknown and missing responses. In total, 80 patients (47.1%) were aged ≥65 years and 90 (52.9%) were aged <65 years; the mean age difference between the two groups was 21.9 years. Global success at EOT in mITT patients was similar in elderly (68.1%) and non-elderly (70.7%) patients (P=0.719). However, global success rates were significantly lower in elderly versus non-elderly patients at 2 and 6 weeks after EOT (P=0.045 and P=0.016, respectively). Ninety-day survival was significantly lower (P=0.006) for elderly (42.8%) versus non-elderly patients (63.3%). The incidence and profile of adverse events were similar in elderly and non-elderly patients. Anidulafungin was effective and safe for treatment of C/IC in elderly ICU patients, despite higher baseline severity of illness scores.Copyright © 2012 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.
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