Posaconazole (POS) Safety and Efficacy in Elderly Patients with Invasive Fungal Infections (IFIs)

JOHN R. PERFECT, MD1, DONALD R. GRAHAM, MD2, GAVIN CORCORAN, MD3, LISA PEDICONE, PhD3, ISSAM RAAD, MD4;

Author address: 

2Springfield Clinic Research, Springfield, IL, 3Schering-Plough Research Institute, Kenilworth, NJ, 4The University of Texas M.D. Anderson Cancer Center, Houston, TX.

Abstract: 

Background: The safety of antifungal agents in elderly patients is of paramount importance because many such patients have complex medical histories that may place them at increased risk for IFIs and serious adverse events (AEs). POS is an oral, extended-spectrum triazole antifungal that has been studied in patients with IFIs. We report on the safety of POS therapy in the treatment of IFIs in elderly patients and provide clinical outcomes data. Methods: An open-label, multicenter clinical trial of oral POS 800 mg/day in divided doses was conducted in patients intolerant of, or with disease refractory to, other antifungal therapy. Of 330 patients, 33 were 65 years old. Duration of POS therapy in elderly patients ranged from 7 to 352 days (median, 103 days). Complete or partial response was considered success; stable or persistent disease was considered non-success. Results: Of 33 elderly patients, 31 had proven/probable IFIs (MSG/EORTC criteria) that were refractory to, or intolerant of, other antifungal therapy, including 13 with aspergillosis, 4 with fusariosis, and 2 with zygomycosis. Of these 31 patients, 23 (74%) were successfully treated with POS. The most common treatment-related AEs in the elderly paralleled those reported in the overall population: nausea (15% elderly; 9% overall), vomiting (9% elderly; 6% overall), and headache (9% elderly; 5% overall). Discontinuation rates in elderly patients and the overall population were comparable. Conclusions: In this salvage therapy trial, POS was safe and well tolerated in elderly patients. Overall, the AEs most commonly associated with POS were similar among the overall and elderly population groups. Thus, POS may provide an option for IFIs in the elderly; it is administered orally, has a favorable safety profile, and has demonstrated clinical activity against diverse IFIs.
2004

abstract No: 

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Full conference title: 

42nd Annual Meeting Infectious Diseases Society of America
    • Infectious Diseases Society of America 42nd