Work

Premedication Practices and Incidence of Infusion-related Reactions in Patients Receiving AMPHOTEC: Data from the PRoACT-Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability

Year: 2008

Type: article

Abstract: Background: Clinical trials have suggested infusion-related reactions (IRR) may occur at a higher rate with Amphotericin B Cholesteryl Sulfate Complex for Injection (AMPHOTEC) vs. other forms of amphotericin B. However, these trials did not permit the use of pre-medications upfront, which are now commonly used. This observational study was undertaken to describe use of pre-medications and determine the rate of IRR in the real-world setting. Methods: The Patient Registry of AMPHOTEC Clinical Tolerability (PRoACT) is a multi-center, worldwide observational registry capturing real-world data about current pre-medication practices and incidence of IRR in patients receiving AMPHOTEC therapy. Patients beginning treatment with AMPHOTEC were eligible for enrollment, and were treated according to their site's standard treatment practice. Incidence of IRR was collected during the first 10 days of AMPHOTEC therapy. Additional labs (serum creatinine, liver function tests) were collected up to 12 wks after treatment start and at drug discontinuation. Results: From November 1, 2006 to December 31, 2007, 180 hospitalized adult and pediatric patients from 20 world-wide sites were enrolled in PRoACT. Evaluable data on 170 patients from 18 sites are available and reported here (median age 37 yrs [range 0–72]; 51.8% male; 21.8% Asian; 78.2% white). There were a total of 1230 AMPHOTEC infusions (mean/median [range] dose 167 mg/150 mg [15–580 mg]). Most infusions (90%; 1105/1230) had pre-medications. Common pre-medications included: dexamethasone, methylprednisone, acetaminophen. The IRR rate was 12% (147/1230). The most common IRR were chills (n = 85), fever (n = 86) and rigors (n = 65); most (86%) were low severity (Common Toxicity Criteria stage 1 or 2). Other IRR occurred in < 1.1% of injections. Pre-treatment was associated with decreased odds for IRR (OR: 0.41, p < .002 [Chi square]). Conclusions: These data suggest a low rate of IRR with AMPHOTEC; pre-treatment is associated with decreased IRR incidence.

Source: International Journal of Infectious Diseases

DOI: 10.1016/j.ijid.2008.05.763

Authors: G. Krivàn, M. Mrsic, K. David, D. Paterson

Institutions: Unified Szent István and Szent László Hospital, University Hospital Centre Zagreb, University of Pittsburgh

Language: English

Topic: Antifungal resistance and susceptibility

Subfield: Infectious Diseases

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,900