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

Paterson, David L., David, Kristin, Mrsic, Mirando, Cetkovsky, Petr, Weng, Xin-Hua, Sterba, Jaroslav, Krivan, Gregerly, Boskovic, Darinka, Lu, Minqiang, Zhu, Li-Ping and on behalf of the PRoACT Investigators (2008) 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. Journal of Antimicrobial Chemotherapy, 62 6: 1392-1400. doi:10.1093/jac/dkn394


Author Paterson, David L.
David, Kristin
Mrsic, Mirando
Cetkovsky, Petr
Weng, Xin-Hua
Sterba, Jaroslav
Krivan, Gregerly
Boskovic, Darinka
Lu, Minqiang
Zhu, Li-Ping
on behalf of the PRoACT Investigators
Title 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
Journal name Journal of Antimicrobial Chemotherapy   Check publisher's open access policy
ISSN 0305-7453
Publication date 2008-09-23
Year available 2008
Sub-type Article (original research)
DOI 10.1093/jac/dkn394
Open Access Status Not yet assessed
Volume 62
Issue 6
Start page 1392
End page 1400
Total pages 9
Editor Johnson, Alan P.
Place of publication United Kingdom
Publisher Oxford University Press
Language eng
Subject C1
920109 Infectious Diseases
110309 Infectious Diseases
Abstract 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.
Formatted abstract
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.
Keyword liposomal
tolerability
fungal infections
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

 
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Created: Sun, 29 Mar 2009, 21:21:52 EST by Carmen Buttery on behalf of UQ Centre for Clinical Research