Journal Article

Safety of Long-Term Oral Posaconazole Use in the Treatment of Refractory Invasive Fungal Infections

Issam I. Raad, John R. Graybill, Ana Beatriz Bustamante, Oliver A. Cornely, Veronica Gaona-Flores, Claude Afif, Donald R. Graham, Richard N. Greenberg, Susan Hadley, Amelia Langston, Ricardo Negroni, John R. Perfect, Punnee Pitisuttithum, Angela Restrepo, Gary Schiller, Lisa Pedicone and Andrew J. Ullmann

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 42, issue 12, pages 1726-1734
Published in print June 2006 | ISSN: 1058-4838
Published online June 2006 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1086/504328
Safety of Long-Term Oral Posaconazole Use in the Treatment of Refractory Invasive Fungal Infections

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

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 ⩾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 ⩾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.

Journal Article.  4895 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.