Comparison of Adverse Event Profiles of Amphotericin B Formulations Using Real-World Data

Yuka Nokura; Mika Maezawa; Koumi Miyasaka; Sakiko Hirofuji; Satoshi Nakao; Moe Yamashita; Nanaka Ichihara; Kana Sugishita; Tomofumi Yamazaki; Hirofumi Tamaki; Kazuhiro Iguchi; Kohei Tahara; Mitsuhiro Nakamura

doi:10.7759/cureus.71588

Comparison of Adverse Event Profiles of Amphotericin B Formulations Using Real-World Data

Cureus. 2024 Oct 16;16(10):e71588. doi: 10.7759/cureus.71588. eCollection 2024 Oct.

Authors

Affiliations

¹ Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
² Department of Pharmacy, Kyushu University Hospital, Fukuoka, JPN.
³ Laboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, JPN.
⁴ Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, Gifu, JPN.

Abstract

Amphotericin B deoxycholate (AMPH-B) is a polyene macrolide with antifungal activity. Liposomal AMPH-B (L-AMB) was developed to reduce side effects while maintaining antifungal activity. This study was aimed at evaluating and comparing the adverse event profiles of AMPH-B and L-AMB using a spontaneous reporting system. We analyzed the adverse event reports of AMPH-B and L-AMB from the United States Food and Drug Administration Adverse Event Reporting System (FAERS). Case report counts of adverse events were generated according to the preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA). Standardized MedDRA queries (SMQs) and system organ classes (SOCs) were used to compare the organ-specific adverse event profiles of AMPH-B and L-AMB. The reporting odds ratio and proportional reporting rate were used to detect pharmacovigilance signals. The FAERS database contains 21,173,818 cases from January 2004 to March 2024. Adverse events were reported in 2438 cases receiving AMPH-B treatment and 3344 cases receiving L-AMB treatment, including 848 and 1591 cases receiving intravenous AMPH-B and L-AMB injections, respectively. The most frequently reported drug-related adverse event in the AMPH-B and L-AMB groups was hypokalemia. SOCs with statistically significant differences were "Inv" (laboratory tests), "Resp" (respiratory, thoracic, and mediastinal disorders), "Genrl" (general and systemic disorders and conditions at the site of administration), "Card" (cardiac disorders), and "Blood" (blood and lymphatic system disorders). No statistically significant difference was observed in the SMQ profile of adverse events in "Renal" (renal and urinary disorders) and "Hepat" (hepatobiliary disorders) between the L-AMB and AMPH-B formulations in this study. Based on real-world data from FAERS, adverse event profiles of AMPH-B and L-AMB were compared. No statistically significant difference was observed in the SMQ profile of adverse events in the renal and hepatic SOCs between the L-AMB and AMPH-B formulations. Our results suggest that L-AMB is more tolerated by the kidneys than AMPH-B.

Keywords: ambisome; amphotericin b; fda adverse event reporting system; fungizone; liposomal amphotericin b.

Grants and funding

The authors disclose the receipt of the following financial support for the research, authorship, and/or publication of this article. This research was partially supported by JSPS KAKENHI,Grant Numbers 23H05264, 21K11100, and 21K06646. The funders played no role in the study design, data collection and analysis, decision to publish this article, or article preparation.