Richardson, Paul G. and Corbacioglu, Selim and Ho, Vincent Trien-Vinh and Kernan, Nancy A. and Lehmann, Leslie and Maguire, Craig and Maglio, Michelle and Hoyle, Margaret and Sardella, Marco and Giralt, Sergio and Holler, Ernst and Carreras, Enric and Niederwieser, Dietger and Soiffer, Robert (2013) Drug safety evaluation of defibrotide. EXPERT OPINION ON DRUG SAFETY, 12 (1). pp. 123-136. ISSN 1474-0338
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | STEM-CELL TRANSPLANTATION; HEPATIC VENOOCCLUSIVE DISEASE; THROMBOTIC THROMBOCYTOPENIC PURPURA; ACUTE MYOCARDIAL-INFARCTION; DEEP VENOUS THROMBOSIS; CONTROLLED CLINICAL-TRIAL; ACUTE-RENAL-FAILURE; BONE-MARROW TRANSPLANTATION; RANDOMIZED CONTROLLED-TRIAL; HIGH-RISK POPULATION; anti-inflammatory; antithrombotic; defibrotide; endothelial protective; prevention; profibrinolytic; prophylaxis; safety; sinusoidal obstruction syndrome; treatment; veno-occlusive disease |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) Medicine > Abteilung für Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation |
| Depositing User: | Petra Gürster |
| Date Deposited: | 27 May 2020 07:58 |
| Last Modified: | 27 May 2020 07:58 |
| URI: | https://pred.uni-regensburg.de/id/eprint/17522 |
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