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


OBJECTIVE
Evaluation of real-life incidence of AMB-D-related adverse-drug effects (ADE) and associated costs.


METHODS
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.


CONCLUSIONS
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.
Pharmacy Division, Hadassah-Hebrew University Medical Center, Kiryat-Hadassah, 91120, Jerusalem, Israel. ehud.horwitz@mail.huji.ac.il
Ehud
E
Horwitz
Oren
O
Shavit
Rivka
R
Shouval
Amnon
A
Hoffman
Mervyn
M
Shapiro
Allon E
AE
Moses
D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000009:adverse effects* / Q000191:economics*; D000935:Antifungal Agents / Q000009:adverse effects* / Q000191:economics*; D002648:Child; D002675:Child, Preschool; D003840:Deoxycholic Acid / Q000009:adverse effects* / Q000191:economics*; D004338:Drug Combinations; D016527:Drug Costs / Q000706:statistics & numerical data*; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D007557:Israel; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D000935:Antifungal Agents; D004338:Drug Combinations; D003840:Deoxycholic Acid; D000666:Amphotericin B; C059765:amphotericin B, deoxycholate drug combination