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Side effects associated with itraconazole therapy

Matthew R Osborn1, Julio C Zuniga-Moya1, Patrick B Mazi1

  • 1Division of Infectious Diseases, Department of Internal Medicine, Washington University School of Medicine, 4523 Clayton Ave, MSC 8051-0043-15, St. Louis, MO 63110, USA.

The Journal of Antimicrobial Chemotherapy
|December 10, 2024
PubMed
Abstract

Insights

Long-term itraconazole therapy for histoplasmosis caused side effects in about a quarter of patients. Higher itraconazole serum levels were linked to adverse events, suggesting monitoring may improve treatment outcomes.

Area of Science:

  • Medical Mycology
  • Clinical Pharmacology

Background:

  • Itraconazole is a primary treatment for fungal infections like histoplasmosis.
  • Limited data exists on long-term itraconazole side effects compared to short-term use.
  • Fluconazole, often considered safer, shows significant toxicity in long-term treatment settings.

Purpose of the Study:

  • To assess the frequency, nature, and timing of itraconazole side effects in histoplasmosis patients.
  • To analyze treatment modifications due to side effects.
  • To investigate the relationship between patient characteristics, itraconazole serum levels, and side effect occurrence.

Main Methods:

  • A retrospective, single-center study of adult histoplasmosis patients on itraconazole for ≥28 days (2002-2021).
  • Characterization of reported side effects.
  • Propensity score matching to compare itraconazole serum levels in patients with and without side effects.

Main Results:

  • 27.8% of patients (63/227) experienced at least one side effect.
  • Common side effects included hepatotoxicity (7.0%), nausea/vomiting (6.6%), and diarrhea (6.2%).
  • Higher median itraconazole serum levels (2.9 vs. 1.8 mcg/mL) were observed in patients with side effects (P=0.009).

Conclusions:

  • Approximately 25% of patients on long-term itraconazole for histoplasmosis reported side effects.
  • Nearly two-thirds of affected patients required therapeutic intervention, including dose reduction or discontinuation.
  • Itraconazole demonstrated a lower side effect frequency compared to fluconazole in other studies.

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