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Posaconazole as salvage treatment of invasive fungal infections in patients with underlying renal impairment.

Publication ,  Journal Article
Hachem, RY; Langston, AA; Graybill, JR; Perfect, JR; Pedicone, LD; Patino, H; Raad, II
Published in: J Antimicrob Chemother
December 2008

OBJECTIVES: The aim of this study is to determine the efficacy and safety of posaconazole in patients with underlying renal impairment. Patients and methods We analysed the efficacy and safety of posaconazole in patients with renal impairment in a post hoc subanalysis of a Phase 3, multicentre, open-label trial in patients with invasive fungal infections (IFIs). In the Phase 3 study, 330 patients intolerant of or with IFIs refractory to standard antifungal therapy received posaconazole 800 mg daily in divided doses. In our subanalysis, 238 patients with proven/probable IFIs, including 65 patients with renal impairment (creatinine clearance < 50 mL/min or serum creatinine (sCR) level >2 mg/dL at baseline) and 173 patients with greater renal function [creatinine clearance >/= 50 mL/min (acceptable renal function)], formed the modified intent-to-treat population. Success was defined as complete or partial response, and non-success was defined as stable disease or treatment failure. RESULTS: Overall response rates were similar in the renal impairment group (49%) and in the acceptable renal function (50%) group. Seventeen of the 41 patients with renal impairment and aspergillosis responded. Adverse events occurred in 32/65 (49%) patients with renal impairment and in 72/173 (42%) patients with acceptable renal function. The most common adverse events in both groups were nausea (14% patients with renal impairment versus 8% with acceptable renal function), altered/elevated levels of other medications (8% versus 2%), increased sCR levels (6% versus 0%), vomiting (6% versus 4%), abdominal pain (5% versus 5%) and dizziness (5% versus 1%). CONCLUSIONS: These results suggest that posaconazole is effective and well tolerated in patients with refractory IFIs regardless of renal impairment.

Duke Scholars

Published In

J Antimicrob Chemother

DOI

EISSN

1460-2091

Publication Date

December 2008

Volume

62

Issue

6

Start / End Page

1386 / 1391

Location

England

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Salvage Therapy
  • Renal Insufficiency
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Aspergillosis
 

Citation

APA
Chicago
ICMJE
MLA
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Hachem, R. Y., Langston, A. A., Graybill, J. R., Perfect, J. R., Pedicone, L. D., Patino, H., & Raad, I. I. (2008). Posaconazole as salvage treatment of invasive fungal infections in patients with underlying renal impairment. J Antimicrob Chemother, 62(6), 1386–1391. https://doi.org/10.1093/jac/dkn401
Hachem, R. Y., A. A. Langston, J. R. Graybill, J. R. Perfect, L. D. Pedicone, H. Patino, and I. I. Raad. “Posaconazole as salvage treatment of invasive fungal infections in patients with underlying renal impairment.J Antimicrob Chemother 62, no. 6 (December 2008): 1386–91. https://doi.org/10.1093/jac/dkn401.
Hachem RY, Langston AA, Graybill JR, Perfect JR, Pedicone LD, Patino H, et al. Posaconazole as salvage treatment of invasive fungal infections in patients with underlying renal impairment. J Antimicrob Chemother. 2008 Dec;62(6):1386–91.
Hachem, R. Y., et al. “Posaconazole as salvage treatment of invasive fungal infections in patients with underlying renal impairment.J Antimicrob Chemother, vol. 62, no. 6, Dec. 2008, pp. 1386–91. Pubmed, doi:10.1093/jac/dkn401.
Hachem RY, Langston AA, Graybill JR, Perfect JR, Pedicone LD, Patino H, Raad II. Posaconazole as salvage treatment of invasive fungal infections in patients with underlying renal impairment. J Antimicrob Chemother. 2008 Dec;62(6):1386–1391.
Journal cover image

Published In

J Antimicrob Chemother

DOI

EISSN

1460-2091

Publication Date

December 2008

Volume

62

Issue

6

Start / End Page

1386 / 1391

Location

England

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Salvage Therapy
  • Renal Insufficiency
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Aspergillosis