Key result
Defibrotide was well tolerated in the majority of studies, demonstrating a largely favorable safety profile with toxicities comparable to control populations in stem-cell transplantation.
Why the study?
Is defibrotide safe for the treatment and prophylaxis of veno-occlusive disease and other conditions?
Is defibrotide safe for the treatment and prophylaxis of veno-occlusive disease and other conditions?
Defibrotide has a favorable safety profile and is well tolerated for the treatment and prophylaxis of veno-occlusive disease.
Answers are grounded in this paper and cite their sources.
May support VOD management in transplantation; leaves open need for randomized safety confirmation.
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.
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Richardson et al. (2012) conducted a review in Hepatic veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS). Defibrotide was evaluated on Safety and tolerability. Defibrotide was well tolerated in the majority of studies, demonstrating a largely favorable safety profile with toxicities comparable to control populations in stem-cell transplantation.
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