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Comparison of Adverse Event Profiles of Amphotericin B Formulations Using Real-World Data
Yuka Nokura1, Mika Maezawa1, Koumi Miyasaka1
1Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Cureus
|November 18, 2024
Summary
This study compared adverse events of Amphotericin B deoxycholate (AMPH-B) and liposomal AMPH-B (L-AMB). Liposomal AMPH-B showed better kidney tolerance, with hypokalemia being the most common adverse event for both antifungals.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Safety
Background:
- Amphotericin B deoxycholate (AMPH-B) is a potent antifungal, but its use is limited by toxicity.
- Liposomal Amphotericin B (L-AMB) was developed to improve the safety profile while retaining efficacy.
- Comparative analysis of real-world adverse event data is crucial for understanding drug safety profiles.
Purpose of the Study:
- To evaluate and compare the adverse event profiles of AMPH-B and L-AMB.
- To identify organ-specific differences in toxicity between the two formulations.
- To assess the safety of L-AMB relative to conventional AMPH-B using pharmacovigilance data.
Main Methods:
- Analysis of adverse event reports from the US FDA Adverse Event Reporting System (FAERS) database (January 2004 - March 2024).
- Utilized Medical Dictionary for Regulatory Activities (MedDRA) for preferred terms, Standardized MedDRA Queries (SMQs), and System Organ Classes (SOCs).
- Employed reporting odds ratio and proportional reporting rate to detect pharmacovigilance signals and compare organ-specific adverse events.
Main Results:
- Hypokalemia was the most frequently reported adverse event for both AMPH-B and L-AMB.
- Statistically significant differences in adverse events were observed in laboratory tests, respiratory, general/administration site, cardiac, and blood/lymphatic system disorders.
- No significant difference was found in renal and hepatic adverse event profiles between L-AMB and AMPH-B, suggesting L-AMB is more kidney-tolerant.
Conclusions:
- Liposomal Amphotericin B (L-AMB) demonstrates a potentially improved safety profile compared to conventional Amphotericin B deoxycholate (AMPH-B), particularly concerning renal toxicity.
- Real-world data from FAERS supports the clinical observation of better kidney tolerance with L-AMB.
- Further pharmacovigilance and clinical studies are warranted to fully elucidate the comparative safety of these antifungal agents.
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