Prospective audit of the effectiveness of hydrocortisone premedication on drug delivery reactions following amphotericin B lipid complex

ABSTRACT

Objective: Amphotericin B lipid complex (ABLC), a lipid-based formulation of amphotericin B, is an effective treatment for fungal infections, but is associated with mild to moderate drug delivery reactions (DDRs), such as fever, rigors and chills, in some patients. Although clinical studies have indicated that premedication with hydrocortisone may reduce the incidence of DDRs, there are currently limited confirmatory data from clinical practice. The aim of the audit was to assess prospectively a hydrocortisone premedication strategy with ABLC to reduce the rate of DDRs.

Methods: Over an 18-month period, all cancer patients treated with ABLC at The Royal Shrewsbury Hospital were audited prospectively. Each patient received 100 mg of intravenous hydrocortisone 15–30 minutes prior to each ABLC infusion. The primary outcome was to determine the DDR rate per cycle of ABLC.

Results: A total of 275 cycles of ABLC (mean dosage 930.6 mg) were administered during the course of the study period, and 16.0% were associated with DDRs. The majority of reactions occurred following the first infusion of a cycle (15.3%; subsequent infusions: 2.9%). The most common DDRs were rigor (15.3%) and fever (12.7%). There was no significant difference in the DDR rate (17.2 vs. 15.5%) or types of reactions between ABLC-naïve and previously treated patients. The dosage of ABLC administered had no effect on the DDR rate. Female gender, being neutropenic and younger age were found to be predictive of having a DDR.

Conclusions: The audit demonstrates that premedication with hydrocortisone results in a low incidence of DDRs following ABLC. The main limitation of this study is the lack of a randomised control group.

Key words: :

• ABLC
• Adverse events
• Audit
• Hydrocortisone
• Premedication

Acknowledgements

Declaration of interest: This study was sponsored by Cephalon Ltd; research activities, data handling, statistical analyses and medical writing services were supported by Cephalon Ltd. The sponsors were not involved in the drafting, preparation or writing of this manuscript. No competing interests exist for either of the authors.

Dr Ian Keary and Mr Thomas Richards of Strategen Ltd provided medical writing services and editorial support for the authors. Strategen Ltd received fees from Cephalon Ltd in this regard.

Notes

* These results were presented as a poster at the 2008 British Oncology Pharmacy Association symposium 17–19th October, Liverpool, UK