title: Efficacy and safety of anidulafungin in elderly, critically ill patients with invasive Candida infections: a post hoc analysis.
abstract: Post 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.
authors.affiliation: University Hospital Attikon, Athens, Greece. gdimop@med.uoa.gr
authors.forename: George
authors.initials: G
authors.lastname: Dimopoulos
authors.forename: José-Artur
authors.initials: JA
authors.lastname: Paiva
authors.forename: Wouter
authors.initials: W
authors.lastname: Meersseman
authors.forename: Jan
authors.initials: J
authors.lastname: Pachl
authors.forename: Ioana
authors.initials: I
authors.lastname: Grigoras
authors.forename: Gabriele
authors.initials: G
authors.lastname: Sganga
authors.forename: Philippe
authors.initials: P
authors.lastname: Montravers
authors.forename: Georg
authors.initials: G
authors.lastname: Auzinger
authors.forename: Marcio Borges
authors.initials: MB
authors.lastname: Sá
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Miller
authors.forename: Tomas
authors.initials: T
authors.lastname: Marček
authors.forename: Michal
authors.initials: M
authors.lastname: Kantecki
authors.forename: Markus
authors.initials: M
authors.lastname: Ruhnke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077612:Anidulafungin; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D058365:Candidiasis, Invasive / Q000188:drug therapy*; D016638:Critical Illness; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D054714:Echinocandins / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D054714:Echinocandins; D000077612:Anidulafungin