JAC Advance Access published online on September 23, 2008
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkn394
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Original research |
Pre-medication practices and incidence of infusion-related reactions in patients receiving AMPHOTEC®: data from the Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability (PRoACT) registry
1 University of Pittsburgh, Pittsburgh, PA, USA 2 Centre for Clinical Research, University of Queensland, Brisbane, Australia 3 ProSanos Corporation, Harrisburg, PA, USA 4 University Hospital Centre, Zagreb, Croatia 5 Institute of Haematology and Blood Transfusion, Prague, Czech Republic 6 Huashan Hospital, Shanghai, China 7 Department of Paediatric Oncology, Brno, Czech Republic 8 Szent Laszlo Hospital, BMT Unit, Budapest, Hungary 9 Clinical Centre of Serbia, Belgrade, Serbia 10 The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
Received 8 July 2008; returned 8 August 2008; revised 15 August 2008; accepted 23 August 2008
* Corresponding author. Tel: +1-717-635-2140; Fax: +1-717-635-2575; E-mail: kristin.david{at}prosanos.com
Background: Clinical studies have suggested that rates of infusion-related reactions (IRRs) may be higher with amphotericin B colloidal dispersion (ABCD) versus other forms of amphotericin B. However, these studies did not permit the use of pre-medications upfront, which are now commonly used.
Objectives: To describe the use of pre-medications and determine the rate of IRRs in the real-world setting.
Methods: PRoACT, a multicentre, worldwide observational registry, captured real-world data about pre-medication practices and IRRs in patients receiving ABCD. Eligible patients were those beginning treatment with ABCD; treatment was according to the site's standard treatment practice. Incidence of IRRs was collected during the first 10 days of ABCD therapy. Clinical response data were collected 12 weeks after treatment start.
Results: One hundred and seventy patients from 21 worldwide sites were included (median age 37 years; 52% male). There were a total of 1230 ABCD infusions (mean dose 2.8 mg/kg/day); 90% of the infusions (1105/1230) had pre-medication. Common pre-medications included corticosteroids, antihistamines, paracetamol (acetaminophen) and metamizole. The overall IRR rate was 12% (147/1230) and was lower in infusions with pre-medication (11%) versus no pre-medication (22%), P < 0.001. Corticosteroids were associated with a decreased incidence of IRRs (P < 0.05), while paracetamol and antihistamines were not. The most common IRRs were chills (7%), fever (7%) and rigors (5%). Clearance of the fungal infection occurred in 52% of the participants.
Conclusions: These data suggest a lower rate of IRRs with ABCD than previously reported. Pre-medication is associated with decreased IRR incidence. Corticosteroids in particular appear to decrease IRRs while paracetamol and antihistamines, though commonly used, do not.
Key Words: liposomal , tolerability , fungal infections