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Efficacy and safety of amphotericin B lipid-based formulations-A systematic review and meta-analysis
Laiza M Steimbach1, Fernanda S Tonin1, Suzane Virtuoso1,2
1Department of Pharmacy, Pharmaceutical Sciences Postgraduate Research Program, Federal University of Paraná, Curitiba, Brazil.
Abstract:
Invasive fungal infections, an important cause of mortality, are primarily treated using amphotericin B, which is available in different formulations, both conventional and lipid-based (liposomal, lipid complex, colloidal dispersion and Intralipid® infusion). The aim of our study was to determine the efficacy and safety of conventional amphotericin B vs its lipid-based formulations. A systematic review followed by pairwise meta-analysis was performed, including randomised controlled trials (RCTs) that evaluated the use of lipid-based amphotericin B in patients with any degree of immunosuppression and susceptibility to invasive fungal infection. An electronic search was conducted using PubMed, Scopus, Web of Science and Scielo databases. Extracted outcomes were related to efficacy (cure) and safety (incidence of adverse events). Results were evaluated and meta-analyses were performed. Twenty-three RCTs were identified (n=2677 participants) for meta-analysis. No significant differences between conventional amphotericin B and any of the five formulations evaluated were observed, with regard to the efficacy analysis. With respect to the adverse events of nephrotoxicity, fever, chills and vomiting, all lipid formulations presented better profiles than the conventional formulation. The present systematic review and meta-analysis showed that conventional amphotericin B presents the same efficacy profile as lipid-based formulations, although the latter were associated with a safer profile.
Insights
Conventional amphotericin B and its lipid formulations show similar efficacy for invasive fungal infections. Lipid formulations offer a safer profile, reducing adverse events like nephrotoxicity and fever.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Medicine
Background:
- Invasive fungal infections (IFIs) are a significant cause of mortality, especially in immunocompromised patients.
- Amphotericin B is a primary antifungal agent, available in conventional and various lipid-based formulations.
- Understanding the comparative efficacy and safety of these formulations is crucial for clinical decision-making.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials (RCTs) comparing conventional amphotericin B with its lipid-based formulations.
- To evaluate the efficacy (cure rates) and safety (adverse events) of these different amphotericin B formulations.
Main Methods:
- A systematic literature search was conducted across major databases (PubMed, Scopus, Web of Science, Scielo).
- Pairwise meta-analysis was performed on data from 23 RCTs involving 2677 participants.
- Outcomes assessed included treatment cure and incidence of adverse events such as nephrotoxicity, fever, chills, and vomiting.
Main Results:
- No statistically significant difference in efficacy was found between conventional amphotericin B and any of the lipid-based formulations.
- Lipid formulations demonstrated a significantly better safety profile, with lower incidence of nephrotoxicity, fever, chills, and vomiting compared to conventional amphotericin B.
Conclusions:
- Conventional amphotericin B and its lipid-based formulations exhibit comparable efficacy in treating invasive fungal infections.
- Lipid-based amphotericin B formulations are associated with improved safety and reduced adverse events, making them a preferable option in clinical practice.
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