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A real-world study based on the FAERS database evaluating adverse drug reactions in three amphotericin B lipid
Binliang Tong1, Jiaqi Wang2, Yanjing Zhang2,3
1Pharmacy Department, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.
Background:
Amphotericin B (AmB) remains the cornerstone in the treatment of severe fungal infections. However, selecting an appropriate lipid-based formulation for different clinical scenarios remains a challenge for clinicians and clinical pharmacists.
Methods:
Adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS) database (Q1 2004-Q3 2024) were retrospectively analysed to assess the safety profiles of three lipid formulations of AmB: liposomal amphotericin B (L-AmB), amphotericin B lipid complex (ABLC), and amphotericin B colloidal dispersion (ABCD). The baseline patient characteristics, AE distributions, and prognostic outcomes of severe AEs were examined. SPSS software was used to compare AE occurrences among the three groups.
Results:
A total of 3284 patient reports were included, comprising 3108 in the L-AmB group, 142 in the ABLC group, and 34 in the ABCD group. Within 30 days, AEs were reported in 666 cases (L-AmB), 72 cases (ABLC), and 13 cases (ABCD) (P < 0.001). AEs were categorised using the System Organ Class (SOC) and Standardized MedDRA Querie (SMQ). Compared with the L-AmB group, the ABLC group had a significantly higher incidence of hypersensitivity and hypertension; whereas hypokalemia was significantly lower (P < 0.001). Compared to the L-AmB and ABLC groups, the ABCD group had a significantly higher incidence of haematopoietic thrombocytopenia (P < 0.001). Prognostic analysis indicated that the incidence of life-threatening events was significantly higher in the ABCD group than in the L-AmB and ABLC groups (P < 0.001).
Conclusion:
The safety profiles of L-AmB, ABLC, and ABCD differ among organ systems. These findings highlight the need for individualised treatment strategies based on drug-specific safety characteristics and patient-specific clinical conditions to ensure optimal drug selection and patient safety.
Insights
Liposomal amphotericin B (L-AmB), amphotericin B lipid complex (ABLC), and amphotericin B colloidal dispersion (ABCD) have distinct safety profiles. Understanding these differences is crucial for selecting the best antifungal treatment for severe fungal infections.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Infectious Diseases
Background:
- Amphotericin B (AmB) is a critical antifungal agent for severe infections.
- Choosing the right lipid formulation of AmB presents a clinical challenge.
- Different AmB lipid formulations possess unique safety profiles.
Purpose of the Study:
- To compare the safety profiles of three AmB lipid formulations: L-AmB, ABLC, and ABCD.
- To analyze adverse event (AE) data from the FDA Adverse Event Reporting System (FAERS).
- To guide optimal drug selection for severe fungal infections.
Main Methods:
- Retrospective analysis of FAERS data (Q1 2004-Q3 2024).
- Examination of patient characteristics, AE distributions, and severe AE outcomes.
- Statistical comparison of AE occurrences across L-AmB, ABLC, and ABCD groups using SPSS software.
Main Results:
- 3284 patient reports analyzed: 3108 (L-AmB), 142 (ABLC), 34 (ABCD).
- AEs within 30 days were significantly different across formulations (P < 0.001).
- ABCD showed higher rates of hypersensitivity, hypertension, and life-threatening events compared to L-AmB and ABLC.
Conclusions:
- Liposomal amphotericin B (L-AmB), amphotericin B lipid complex (ABLC), and amphotericin B colloidal dispersion (ABCD) exhibit varying safety profiles.
- Individualized treatment strategies are essential, considering drug-specific safety and patient conditions.
- Optimizing drug selection enhances patient safety in managing severe fungal infections.
