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

Publication ,  Journal Article
Raad, II; Graybill, JR; Bustamante, AB; Cornely, OA; Gaona-Flores, V; Afif, C; Graham, DR; Greenberg, RN; Hadley, S; Langston, A; Negroni, R ...
Published in: Clin Infect Dis
June 15, 2006

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.

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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

June 15, 2006

Volume

42

Issue

12

Start / End Page

1726 / 1734

Location

United States

Related Subject Headings

  • Triazoles
  • Mycoses
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Drug Administration Schedule
  • Dose-Response Relationship, Drug
  • Antifungal Agents
 

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Raad, I. I., Graybill, J. R., Bustamante, A. B., Cornely, O. A., Gaona-Flores, V., Afif, C., … Ullmann, A. J. (2006). Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections. Clin Infect Dis, 42(12), 1726–1734. https://doi.org/10.1086/504328
Raad, Issam I., John R. Graybill, Ana Beatriz Bustamante, Oliver A. Cornely, Veronica Gaona-Flores, Claude Afif, Donald R. Graham, et al. “Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections.Clin Infect Dis 42, no. 12 (June 15, 2006): 1726–34. https://doi.org/10.1086/504328.
Raad II, Graybill JR, Bustamante AB, Cornely OA, Gaona-Flores V, Afif C, et al. Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections. Clin Infect Dis. 2006 Jun 15;42(12):1726–34.
Raad, Issam I., et al. “Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections.Clin Infect Dis, vol. 42, no. 12, June 2006, pp. 1726–34. Pubmed, doi:10.1086/504328.
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. Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections. Clin Infect Dis. 2006 Jun 15;42(12):1726–1734.
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

June 15, 2006

Volume

42

Issue

12

Start / End Page

1726 / 1734

Location

United States

Related Subject Headings

  • Triazoles
  • Mycoses
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Drug Administration Schedule
  • Dose-Response Relationship, Drug
  • Antifungal Agents