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Comparative safety of amphotericin B lipid complex and amphotericin B deoxycholate as aerosolized antifungal
Richard H Drew1, Elizabeth Dodds Ashley, Daniel K Benjamin
1Division of Infectious Diseases, Duke University Medical Center, Durham, NC 27710, USA. richard.drew@duke.edu
Background:
Aerosolized administrations of amphotericin B deoxycholate (AmBd) and amphotericin B lipid complex (ABLC) in lung transplant recipients were compared for safety and tolerability. The incidence of invasive fungal infections in patients receiving aerosolized amphotericin B formulations as sole prophylaxis was determined.
Methods:
A prospective, randomized (1:1), double-blinded trial was conducted with 100 subjects. AmBd and ABLC were administered postoperatively by nebulizer at doses of 25 mg and 50 mg, respectively, which were doubled in mechanically ventilated patients. The planned treatment was once every day for 4 days, then once per week for 7 weeks. Treatment-related adverse events and invasive fungal infections were quantitated for 2 months after study drug initiation.
Results:
Intent-to-treat analysis revealed study drug was discontinued for intolerance in 6 of 49 (12.2%) and 3 of 51 (5.9%) patients in the AmBd- and ABLC-treated groups, respectively (p=0.313). Subjects receiving AmBd were more likely to have experienced an adverse event (odds ratio 2.16, 95% confidence interval 1.10, 4.24, p=0.02). Primary prophylaxis failure within 2 months of study drug initiation was observed in 7 of 49 (14.3%) AmBd-treated patients and 6 of 51 (11.8%) ABLC-treated patients. No fungal pneumonias were observed. Only two (2%) patients experienced documented primary prophylaxis failure with Aspergillus infections within the follow-up period.
Conclusions:
Both aerosol AmBd and ABLC appear to be associated with a low rate of invasive pulmonary fungal infection in the early posttransplant period. Patients receiving ABLC were less likely to experience a treatment-related adverse event.
Insights
Aerosolized amphotericin B lipid complex (ABLC) showed better tolerability than amphotericin B deoxycholate (AmBd) in lung transplant recipients, with similar efficacy in preventing invasive fungal infections.
Area of Science:
- Pulmonary Medicine
- Transplant Surgery
- Infectious Diseases
Background:
- Lung transplant recipients are at high risk for invasive fungal infections.
- Prophylaxis with aerosolized antifungals is crucial in this population.
- Comparing safety and efficacy of different antifungal formulations is essential.
Purpose of the Study:
- To compare the safety and tolerability of aerosolized amphotericin B deoxycholate (AmBd) versus amphotericin B lipid complex (ABLC) in lung transplant recipients.
- To determine the incidence of invasive fungal infections with these agents as sole prophylaxis.
Main Methods:
- A prospective, randomized, double-blinded trial involving 100 lung transplant recipients.
- Administration of AmBd (25 mg) or ABLC (50 mg) via nebulizer, with doubled doses for ventilated patients.
- Quantification of treatment-related adverse events and invasive fungal infections over 2 months.
Main Results:
- Fewer patients receiving ABLC discontinued treatment due to intolerance compared to AmBd (5.9% vs 12.2%).
- AmBd-treated patients were more likely to experience adverse events (OR 2.16, p=0.02).
- Similar rates of primary prophylaxis failure were observed (14.3% for AmBd, 11.8% for ABLC), with only 2% experiencing Aspergillus infections.
Conclusions:
- Both aerosolized AmBd and ABLC demonstrate low rates of invasive pulmonary fungal infections in early post-transplant period.
- ABLC is associated with a lower incidence of treatment-related adverse events compared to AmBd.
- Aerosolized ABLC may be a preferred option for antifungal prophylaxis in lung transplant recipients due to improved tolerability.
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