Drug safety evaluation of defibrotide Journal Article


Authors: Richardson, P. G.; Corbacioglu, S.; Ho, V. T. V.; Kernan, N. A.; Lehmann, L.; Maguire, C.; Maglio, M.; Hoyle, M.; Sardella, M.; Giralt, S.; Holler, E.; Carreras, E.; Niederwieser, D.; Soiffer, R.
Article Title: Drug safety evaluation of defibrotide
Abstract: Introduction: Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of chemotherapeutic conditioning used in preparation for hematopoietic stem-cell transplantation (SCT). Defibrotide (DF) has been shown in Phase II and III trials to improve complete response in patients with severe VOD (sVOD). None of the articles, to date, provide a comprehensive review of the safety of DF in VOD and/or a range of other conditions. Areas covered: This article reviews current clinical findings on DF, primarily in terms of safety for use in treatment and prophylaxis of VOD, and relevant safety data for its use in other diseases. The literature review was conducted using a PubMed search with the fixed term 'defibrotide' in combination with ≥ 1 of 'safety', 'veno-occlusive disease' (with and without 'treatment', 'prevention'), 'oncology', 'myeloma', 'microangiopathy', 'anti-thrombotic' and 'peripheral vascular disorder'. Related articles from the EBMT and ASH conference websites were also included. Expert opinion: DF was well tolerated in majority of the studies. The safety profile of DF is largely favourable with toxicities comparable to control populations in the setting of SCT complicated by sVOD. © 2013 Informa UK, Ltd.
Keywords: treatment; prophylaxis; safety; prevention; veno-occlusive disease; defibrotide; sinusoidal obstruction syndrome; anti-inflammatory; antithrombotic; endothelial protective; profibrinolytic
Journal Title: Expert Opinion on Drug Safety
Volume: 12
Issue: 1
ISSN: 1474-0338
Publisher: Informa Healthcare  
Date Published: 2013-01-01
Start Page: 123
End Page: 136
Language: English
DOI: 10.1517/14740338.2012.749855
PROVIDER: scopus
PUBMED: 23228043
DOI/URL:
Notes: --- - "Export Date: 2 January 2013" - "CODEN: EODSA" - "Source: Scopus"
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MSK Authors
  1. Nancy Kernan
    493 Kernan
  2. Sergio Andres Giralt
    798 Giralt