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 real-life 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 AMB-D 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 <euro>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.
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 real-life 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 AMB-D 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 <euro>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.
Authors: Thomas J Walsh; Elias J Anaissie; David W Denning; Raoul Herbrecht; Dimitrios P Kontoyiannis; Kieren A Marr; Vicki A Morrison; Brahm H Segal; William J Steinbach; David A Stevens; Jo-Anne van Burik; John R Wingard; Thomas F Patterson Journal: Clin Infect Dis Date: 2008-02-01 Impact factor: 9.079
Authors: Stephan Harbarth; John P Burke; James F Lloyd; R Scott Evans; Stanley L Pestotnik; Matthew H Samore Journal: Clin Infect Dis Date: 2002-12-02 Impact factor: 9.079
Authors: T J Walsh; R W Finberg; C Arndt; J Hiemenz; C Schwartz; D Bodensteiner; P Pappas; N Seibel; R N Greenberg; S Dummer; M Schuster; J S Holcenberg Journal: N Engl J Med Date: 1999-03-11 Impact factor: 91.245
Authors: Jane P Barrett; Katerina A Vardulaki; Christopher Conlon; Jonathan Cooke; Pascual Daza-Ramirez; E Glyn V Evans; Peter M Hawkey; Raoul Herbrecht; David I Marks; Jose M Moraleda; Gilbert R Park; Stephen J Senn; Claudio Viscoli Journal: Clin Ther Date: 2003-05 Impact factor: 3.393
Authors: Rebecca S Campbell; Paresh Chaudhari; Harlen D Hays; Robert J Taylor; Brian H Nathanson; Samuel A Bozzette; David L Horn Journal: Clinicoecon Outcomes Res Date: 2013-10-24