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An internet-based multinational study of patients receiving Amphotericin B products [Abstract]

Milligan, D., Rayon Suarez, C., Tramarin, A., Ullmann, A. J., Wandt, H., Bacchus-Gerybadze, L., Lopez Jiminez, F.J., Chopra, R., Sanz Alonso, M. A., Nowak, R., Garcia de Soria, V. G., Irone, M., Egerer, G., Vazquez Lopez, L., Sandoe, J. and Barnes, Rosemary Ann 2001. An internet-based multinational study of patients receiving Amphotericin B products [Abstract]. Clinical Infectious Diseases 33 (7) , p. 1225. 10.1086/520257

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Abstract

Background: Amphotericin B (amB) has been the standard therapy for most systemic mycoses but is associated with significant adverse events (AEs) including nephrotoxicity (NT). Lipid-based formulations of amB (l-amB) have been developed to diminish these toxicities. Objectives were to estimate response to therapy, identify the incidence of NT and other AEs, and assess the use of medical resources used to monitor and treat NT and other AEs. Methods: A multinational observational study was initiated to prospectively collect data on hospitalized adult patients (pts) receiving amB or l-amB. The first day of therapy constituted the beginning of the observation period. Pts were followed until discharge. Data were entered into a relational database via the Internet using validated software. NT was defined a priori as a 50% increase in baseline serum creatinine (SCr) with a peak of 2.0mg/dl. Results: From 12/00 to 4/01, 16 European hospitals contributed data on 123 pts. 94 pts had complete records and were evaluated. 68% initially received amB, 13% lipid complex, 18% liposomal formulation, and 1% colloidal dispersion. Gender, race, and baseline SCr did not differ by therapy (59% male, 97% Caucasian, 1.0 mg/dl). AmB pts were older than l-amB pts (53 vs 45 yrs, p50.01). 14% of all pts had proven fungal infections at therapy start. 62% of these documented infections were candida. Leukemia or lymphomas were most prevalent medical conditions (79%). 8 of the 11 allogeneic bone marrow transplant pts received l-amB. 23% of amB switched to l-amB. Favorable response based on initial therapy was 60% for amB and 37% for l-amB pts. Reported AEs were 73% for amB and 40% for l-amB pts. Occurrence of NT was 23% for amB and 15% for l-amB pts. On average, any pt initially treated with amB or l-amB were ordered 1.3 or 0.7 laboratory tests, 0.1 or 0.1 imaging procedures, 5.5 or 0.3 medications, and 1.9 or 0.3 consultations due to drug-related AEs. Conclusions: Use of the Internet has to lead to efficiency in data collection. AmB and l-amB drug-related AEs occurred frequently and contributed to an increase in medical resources consumed. L-amB may reduce the incidence of certain AEs compared to amB and influence therapy costs.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: Q Science > QR Microbiology
R Medicine > R Medicine (General)
Additional Information: Abstracts of the 39th annual meeting of the Infectious Diseases Society of America October 25-28, 2001
Publisher: University of Chicago Press
ISSN: 1058-4838
Last Modified: 04 Jun 2017 04:27
URI: http://orca-mwe.cf.ac.uk/id/eprint/39476

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