Evaluating real-life clinical and economical burden of amphotericin-B deoxycholate adverse reactions

Abstract

Background: Amphotericin-B (AMB) is associated with toxicity such as renal impairment, hypokalemia and infusion-related events (IRE). With the advent of AMB lipid formulations and newer antifungal drugs, presenting improved safety profiles, it was suggested that using the conventional deoxycholate (AMB-D) formulation should no longer be regarded acceptable. Objectives: Evaluation of reallife incidence of AMB-D-related adverse-drug effects (ADE) and associated costs. Setting: Hadassah Hebrew University Medical Center, Jerusalem, Israel, a tertiary 1,100-bed teaching hospital. Methods: A 1-year single-center prospective observational study following all patients administered AMB-D. Various parameters related to AMBD administration were recorded. Main outcome measures: Subsequent ADE-related events, discontinuations, switch to alternative antifungals and related resource-utilization were monitored. Results: Among 119 patients (60 children, 59 adults) receiving AMB-D, serum creatinine doubling from baseline, hypokalemia and IRE occurred in 14.3 %(15 %in children, 13.6 % in adults), 16.8 % (16.6 % in children, 16.9 % in adults) and 10.9 % (10 % in children, 11.8 % in adults), respectively. AMB-D was discontinued due to an ADE in 12.6 % of patients (6.7 % in children, 18.6 % in adults). The total annual cost associated with AMB-D use was €58,600. Conclusion: The clinical as well as economic burden of AMB-D associated ADE, as observed in real-life settings, appears to be manageable. Considering the significant cost implications associated, as suggested by simulated evaluation of an overall theoretic replacement of AMB-D by an equivalent volume of alternative antifungals, total abandonment of AMB-D appears unjustified. © Springer Science+Business Media B.V. 2012.