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- Title
Safety of Long-Term Oral Posaconazole Use in the Treatment of Refractory Invasive Fungal Infections.
- Authors
Raad, Issam I.; Graybill, John R.; Bustamante, Ana Beatriz; Cornely, Oliver A.; Gaona-Flores, Veronica; Afif, Claude; Graham, Donald R.; Greenberg, Richard N.; Hadley, Susan; Langston, Amelia; Negroni, Ricardo; Perfect, John R.; Pitisuttithum, Punnee; Restrepo, Angela; Schiller, Gary; Pedicone, Lisa; Ullmann, Andrew J.
- 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%). Treatmentrelated 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.
- Subjects
MYCOSES; IMMUNOSUPPRESSION; CRITICALLY ill; HOSPITAL patients; ANTIFUNGAL agents; TRIAZOLES
- Publication
Clinical Infectious Diseases, 2006, Vol 42, Issue 12, p1726
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1086/504328