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Title: Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections
Authors: 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
Andrew J. Ullmann
University of Texas MD Anderson Cancer Center
University of Texas Health Science Center at San Antonio
Springfield Clinic
University of Kentucky Chandler Medical Center
Tufts Medical Center
Emory University Hospital
Duke University School of Medicine
David Geffen School of Medicine at UCLA
Merck & Co., Inc.
Hospital Nacional Cayetano Heredia
Instituto Mexicano del Seguro Social
Hospital de Infecciosas Francisco Javier Muniz
Clinica Cardiovascular Colombiana
Mahidol University
University of Cologne
Johannes Gutenberg Universitat Mainz
Keywords: Medicine
Issue Date: 15-Jun-2006
Citation: Clinical Infectious Diseases. Vol.42, No.12 (2006), 1726-1734
Abstract: 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. © 2006 by the Infectious Diseases Society of America. All rights reserved.
ISSN: 10584838
Appears in Collections:Scopus 2006-2010

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