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April 03, 2003. Argatroban is a small molecule direct thrombin inhibitor sold in the U.S. as Texas Biotechnology (NASDAQ: TXBI) and GlaxoSmithKline’s (NYSE: GSK) Novastan. In a modestly-powered trial, argatroban in combination with a glycoprotein (gp) IIb/IIIa inhibitor was shown to provide a therapeutic effect for patients undergoing percutaneous coronary interventions (PCI). The data, presented at the recently concluded American College of Cardiology meeting, support further, more rigorous, investigation of argatroban / gp IIb/IIIa inhibitor combination therapy for patients undergoing PCI.
Currently, Argatroban is indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia, and as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia undergoing PCI. It has not enjoyed the label expanding efficacy profiles generated by The Medicines Company’s (NASDAQ: MDCO) direct thrombin inhibitor Angiomax in various coronary artery thrombotic scenarios in samplings of the general population. More rigorous investigation is unlikely to show that argatroban has a superior magnitude of therapeutic effect in these scenarios, but might provide some evidence of relative non-inferiority sufficient enough for label expansion. In any case, Angiomax should continue to be the direct thrombin inhibitor of choice for coronary arterial thrombotic lesions for the foreseeable future.
In a pilot study, argatroban was administered in patients undergoing PCI as a 250 mcg/kg bolus followed by 15 mcg/kg/min during the procedure. This dosing scheme was augmented when biochemical evidence of subtherapeutic blood levels was obtained. A gp IIb/IIIa inhibitor was administered concurrently. The primary composite efficacy endpoint was vascular death, myocardial infarction, or urgent revascularization at 30 days.
101 patients were enrolled and completed the PCI procedure. Abciximab (Eli Lilly’s [NYSE: LLY] ReoPro) was given to 99 study subjects and eptifibatide (Millennium’s [NASDAQ: MLNM] Integrilin) was given to 2 patients. 96 patients were treated with stenting.
The primary efficacy endpoint occurred in 3 (3%) study subjects. Overall, there were no vascular deaths and 3 myocardial infarctions, 2 of which were accompanied by urgent revascularizations. Argatroban’s adverse effect profile was reassuring with only 2 major bleeding events observed.
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