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Argatroban. (New & Approved).

(Texas Biotechnology, GlaxoSmithKline)

A synthetic direct thrombin inhibitor, approved for use as an anticoagulant for people who have or who are at risk of heparin-induced thrombocytopenia (HIT) and are undergoing percutaneous coronary interventions (PCIs). Previously approved for prophylaxis or treatment of thrombosis in people with HIT. The first direct thrombin inhibitor approved for HIT patients who are undergoing angioplasty. Argatroban does not have a trade name.

* Recommended Dosage: An intravenous bolus, followed by an infusion for the duration of angioplasty. Can be continued at a lower infusion rate after the procedure if anticoagulation is required.

* Special Considerations: Not approved for use in bypass surgery or other cardiac indications.

* Comment: Approval was based on studies of 91 patients undergoing PCIs who had HIT or heparin-dependent antibodies. "You could safely and effectively perform angioplasty in patients in this very prothrombotic state," said one of the investigators, Dr. William Matthai, an interventional cardiologist at the University of Pennsylvania, Philadelphia. Rates of major bleeding and intracranial hemorrhage, were similar to those in historical controls of heparinized patients undergoing PCIs.

No other agent is approved for patients with HIT who are undergoing angioplasty, but argatroban and other direct thrombin inhibitors have been used off-label for this indication, he noted. HIT, an immune-mediated reaction to heparin associated with thrombocytopenia, is paradoxically associated with thrombosis rather than increased bleeding. The incidence may be as high as 1% in some populations who have received heparin, said Dr. Matthai, who is a consultant to, is on the speaker's bureau for, and has received research funding from the manufacturers of argatroban.
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Author:Mechcatie, Elizabeth
Publication:OB GYN News
Date:May 15, 2002
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