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 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: Ehud Horwitz, Oren Shavit, Rivka Shouval, Amnon Hoffman, Mervyn Shapiro, Allon E Moses
• Journal: International journal of clinical pharmacy (Int J Clin Pharm) Vol. 34 Issue 4 Pg. 611-7 (Aug 2012) ISSN: 2210-7711 [Electronic] Netherlands
• PMID: 22674178 (Publication Type: Journal Article)

Chemical References

• Antifungal Agents
• Drug Combinations
• Deoxycholic Acid
• Amphotericin B
• amphotericin B, deoxycholate drug combination

Topics

• Adolescent
• Adult
• Aged
• Amphotericin B (adverse effects, economics)
• Antifungal Agents (adverse effects, economics)
• Child
• Child, Preschool
• Deoxycholic Acid (adverse effects, economics)
• Drug Combinations
• Drug Costs (statistics & numerical data)
• Female
• Health Care Costs (statistics & numerical data)
• Humans
• Infant
• Israel
• Male
• Middle Aged
• Prospective Studies