Clinical Trials of Fondaparinux

Fondaparinux (GlaxoSmithKline) has been evaluated in several clinical trials for the prevention of venous thromboembolism in patients undergoing major orthopedic surgery (148-151,175,176). Approval was obtained for use in hip fracture, hip replacement, and knee replacement surgeries (177). Dosing of fondaparinux is once daily at 2.5 mg s.c. to be started not before 6-8 h after surgery to avoid unwanted bleeding. Patients with low body weight and renal insufficiency require dose adjustment. Overall, there was no reduction in the bleeding risk compared to enoxaparin. Monitoring is not recommended. However, it is advised to closely monitor any thrombocytopenia under fondaparinux treatment. If the platelet count falls to < 100,000 jxl 1 fondaparinux should be discontinued, and it should be used with caution in patients with a history of HIT.

Following the success of these trials, fondaparinux was evaluated in several trials of patients undergoing high-risk abdominal surgery and in acutely ill medical patients with restricted mobility (178,179). The global MATISSE trials evaluated fondaparinux for the treatment of patients with acute deep-vein thrombosis (DVT) and acute pulmonary embolism (PE) (180,181). Approval was recently obtained for treatment of acute DVT when administered in conjunction with warfarin and for the treatment of acute PE when administered in conjunction with warfarin when initial therapy is administered in the hospital. The treatment dose is 7.5 mg s.c. daily for patients with a body weight between 50 and 100 kg. Dose adjustment is necessary in patients with low body weight.

Other clinical settings in which fondaparinux is being studied include interventional cardiology procedures, adjunct treatment to thrombolytic agents, acute coronary syndrome, special population studies, and drug interaction studies.

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