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Published on 29 August 2013

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Exembol® receives acceptance from the Scottish Medicines Consortium

 

 

Exembol® is a selective direct thrombin inhibitor that reversibly inhibits both free and clot-bound thrombin.[1] Anticoagulant effects are produced rapidly with a predictable dose response effect.[2] Exembol® has a short half-life[1] and its anticoagulant effects are rapidly reversible.[2]
Studies have shown that Exembol® is generally well tolerated and improves patient outcomes in HIT.[3] A study of 497 HIT patients demonstrated that Exembol® therapy significantly reduced the risk of new thrombosis and death due to thrombosis in patients with HIT compared to a historical control group.[3] In addition the Exembol® treated patients had a more rapid recovery of platelet count. These benefits were realised without an increased bleeding risk compared with historical control group patients who received standard treatment at that time.[3] Exembol® has also been shown to provide effective anticoagulation in patients with renal dysfunction or failure,[4] conditions often associated with HIT patients in an intensive care unit setting.
The SMC’s decision means that adult patients with suspected or confirmed heparin-induced thrombocytopenia type II (HIT) who require parenteral antithrombotic therapy, will now be able to more readily get access to Exembol® on the NHS in Scotland. Treatment with Exembol® is included in the British Society for Haematology guidelines for patients with HIT.[5]
“HIT is relatively uncommon, but it is a real issue with potentially devastating outcomes for patients,” says Professor Nigel Webster, ICU Physician, Aberdeen. “The SMC guidance represents a therapeutic advance in management of HIT, and Exembol® is a welcome addition to the category.”
References:
  1. Exembol (argatroban) Summary of Product Characteristics. 2012
  2. Swan SK, Hursting MJ. The pharmacokinetics and pharmacodynamics of argatroban: effects of age, gender and hepatic or renal dysfunction. Pharmacotherapy 2000;20(3):318-329
  3. Lewis BE et al. Argatroban anticoagulant therapy in patients with heparin-induced thrombocytopenia. Circulation 2001;103:1838-1843
  4. Hursting MJ, Murray PT. Argatroban anticoagulation in renal dysfunction: a literature analysis. Nephron Clin Pract 2008;109:c80-c94
  5. Watson et al. Guidelines on the diagnosis and management of heparin-induced thrombocytopenia: second edition. Br J Haematol. 2012 Dec:159(5): 528-40 doi: 10.1111/bjh.12059. Epub 2012 Oct 9


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