Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections.

Published

Journal Article

BACKGROUND: Invasive fungal infections are found most frequently in immunosuppressed and critically ill hospitalized patients. Antifungal therapy is often required for long periods. Safety data from the clinical development program of the triazole antifungal agent, posaconazole, were analyzed. METHODS: A total of 428 patients with refractory invasive fungal infections (n = 362) or febrile neutropenia (n = 66) received posaconazole in 2 phase II/III open-label clinical trials. Also, 109 of these patients received posaconazole therapy for > or = 6 months. Incidences of treatment-emergent, treatment-related, and serious adverse events and abnormal laboratory parameters were recorded during these studies. RESULTS: Treatment-emergent, treatment-related adverse events were reported in 38% of the overall patient population. The most common treatment-related adverse events were nausea (8%) and vomiting (6%). Treatment-related serious adverse events occurred in 8% of patients. Low rates of treatment-related corrected QT interval and/or QT interval prolongation (1%) and elevation of hepatic enzymes (2%) were reported as adverse events. Treatment-emergent, treatment-related adverse events occurred at similar rates in patients who received posaconazole therapy for < 6 months and > or = 6 months. CONCLUSIONS: Prolonged posaconazole treatment was associated with a generally favorable safety profile in seriously ill patients with refractory invasive fungal infections. Long-term therapy did not increase the risk of any individual adverse event, and no unique adverse event was observed with longer exposure to posaconazole.

Full Text

Duke Authors

Cited Authors

  • Raad, II; Graybill, JR; Bustamante, AB; Cornely, OA; Gaona-Flores, V; Afif, C; Graham, DR; Greenberg, RN; Hadley, S; Langston, A; Negroni, R; Perfect, JR; Pitisuttithum, P; Restrepo, A; Schiller, G; Pedicone, L; Ullmann, AJ

Published Date

  • June 2006

Published In

Volume / Issue

  • 42 / 12

Start / End Page

  • 1726 - 1734

PubMed ID

  • 16705579

Pubmed Central ID

  • 16705579

Electronic International Standard Serial Number (EISSN)

  • 1537-6591

International Standard Serial Number (ISSN)

  • 1058-4838

Digital Object Identifier (DOI)

  • 10.1086/504328

Language

  • eng