Efficacy and safety of anidulafungin in elderly, critically ill patients with invasive Candida infections: a post hoc analysis

• Published in: International journal of antimicrobial agents Vol. 40; no. 6; pp. 521 - 526
• Main Authors: Dimopoulos, George, Paiva, José-Artur, Meersseman, Wouter, Pachl, Jan, Grigoras, Ioana, Sganga, Gabriele, Montravers, Philippe, Auzinger, Georg, Sá, Marcio Borges, Miller, Paul J, Marček, Tomas, Kantecki, Michal, Ruhnke, Markus
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.12.2012
• Subjects: Adult; Aged; Aged, 80 and over; anidulafungin; anti-infective agents; Antifungal Agents - administration & dosage; Antifungal Agents - adverse effects; Azole; Candida; Candidaemia; candidiasis; Candidiasis, Invasive - drug therapy; Critical Illness; Drug-Related Side Effects and Adverse Reactions - epidemiology; Echinocandin; Echinocandins - administration & dosage; Echinocandins - adverse effects; Elderly; Female; Global success; Humans; Incidence; Infectious Disease; Male; Middle Aged; neoplasms; neutropenia; organ transplantation; patients; Post hoc analysis; Survival Analysis; Treatment Outcome; Echinocandin; Azole; Global success; Elderly; Post hoc analysis; Candidaemia
• ISSN: 0924-8579; 1872-7913
• DOI: 10.1016/j.ijantimicag.2012.07.018

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 (200mg on Day 1, 100mg/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.