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Safety of aerosolized amphotericin B lipid complex in lung transplant recipients
S M Palmer1, R H Drew, J D Whitehouse
1Division of Pulmonary and Critical Care Medicine, Duke University Medical Center, Durham, NC 22710, USA.
Background:
Fungal infections remain an important cause of morbidity and mortality in lung transplant recipients. Aerosolized amphotericin B lipid complex (ABLC) may be more efficacious than conventional amphotericin B in the prevention of fungal infections in animal models, but experience with aerosolized ABLC in humans is lacking.
Methods:
We conducted a prospective, noncomparative study designed to evaluate safety of aerosolized ABLC in lung or heart-lung transplant recipients.
Results:
A total of 381 treatments were administered to 51 patients. Complete spirometry records were available for 335 treatments (69 in intubated patients, 266 in extubated patients). ABLC was subjectively well tolerated in 98% of patients. Pulmonary mechanics worsened by 20% or more posttreatment in less than 5% of all treatments. There were no significant adverse events related to study medication in any patient, and 1-year survival for all enrolled patients was 78%.
Conclusion:
Administration of nebulized ABLC is safe in the short-term and well-tolerated in lung transplant recipients. Additional prospective, randomized studies are needed to determine the efficacy of aerosolized ABLC alone or in conjunction with systemic therapies in the prevention of fungal infections in lung transplant recipients.
Insights
Nebulized amphotericin B lipid complex (ABLC) is safe and well-tolerated for lung transplant recipients. Further randomized trials are needed to confirm its efficacy in preventing fungal infections.
Area of Science:
- Pulmonology
- Transplant Medicine
- Infectious Diseases
Background:
- Fungal infections pose significant risks for lung transplant recipients.
- Aerosolized amphotericin B lipid complex (ABLC) shows promise in animal models for fungal infection prevention.
- Human data on aerosolized ABLC safety and efficacy is limited.
Purpose of the Study:
- To evaluate the safety of aerosolized amphotericin B lipid complex (ABLC) in lung and heart-lung transplant recipients.
- To assess the tolerability and adverse events associated with nebulized ABLC administration.
- To gather preliminary data for future efficacy studies.
Main Methods:
- Prospective, noncomparative study design.
- Administration of 381 aerosolized ABLC treatments to 51 lung or heart-lung transplant recipients.
- Monitoring of pulmonary mechanics via spirometry and assessment of adverse events.
Main Results:
- Aerosolized ABLC was subjectively well tolerated in 98% of patients.
- Significant pulmonary mechanics worsening (≥20%) occurred in less than 5% of treatments.
- No significant study medication-related adverse events were observed; 1-year survival was 78%.
Conclusions:
- Short-term administration of nebulized ABLC is safe and well-tolerated in lung transplant recipients.
- Further prospective, randomized studies are required to establish the efficacy of aerosolized ABLC.
- Efficacy needs evaluation both as monotherapy and in combination with systemic treatments for fungal infection prevention.
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