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Drug Safety

Erschienen in:

01.03.2008 | Review Article

A Benefit-Risk Review of Systemic Haemostatic Agents

Part 1: In Major Surgery

verfasst von: Dr Ian S. Fraser, Robert J. Porte, Peter A. Kouides, Andrea S. Lukes

Erschienen in: Drug Safety | Ausgabe 3/2008

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Abstract

Systemic haemostatic agents play an important role in the management of blood loss during major surgery where significant blood loss is likely and their use has increased in recent times as a consequence of demand for blood products outstripping supply and the risks associated with transfusions. Their main application is as prophylaxis to reduce bleeding in major surgery, including cardiac and orthopaedic surgery and orthotopic liver transplantation. Aprotinin has been the predominant agent used in this setting; of the other antifibrinolytic agents that have been studied, tranexamic acid is the most effective and e-aminocaproic acid may also have a role. Eptacog alfa (recombinant factor VIIa) has also shown promise. Tranexamic acid, e-aminocaproic acid and eptacog alfa are generally well tolerated; however, when considering the methods to reduce or prevent blood loss intra- and postoperatively, the benefits of these agents need to be weighed against the risk of adverse events. Recently, concerns have been raised about the safety of aprotinin after an association between increased renal dysfunction and mortality was shown in retrospective observational studies and an increase in allcause mortality with aprotinin relative to tranexamic acid or e-aminocaproic acid was seen after a pre-planned periodic analysis of the large BART (Blood conservation using Antifibrinolytics in a Randomized Trial) study. The latter finding resulted in the trial being halted, and aprotinin has subsequently been withdrawn from the market pending detailed analysis of efficacy and safety results from the study. Part 1 of this benefit-risk review examines the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in surgery, and provides individual benefit-risk profiles that may assist clinicians in selecting appropriate pharmacological therapy in this setting.

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Titel: A Benefit-Risk Review of Systemic Haemostatic Agents
Part 1: In Major Surgery
verfasst von: Dr Ian S. Fraser
Robert J. Porte
Peter A. Kouides
Andrea S. Lukes
Publikationsdatum: 01.03.2008
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 3/2008
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.2165/00002018-200831030-00003

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

A Benefit-Risk Review of Systemic Haemostatic Agents

Part 1: In Major Surgery

Abstract

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Abstract

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