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Published on: March 14, 2014
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.
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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