Abstract
Background: The standard initial treatment of venous thromboembolism (VTE) patients in Japan is intravenous unfractionated heparin, requiring laboratory monitoring and hospitalization. Fondaparinux is a synthetic antithrombotic agent with specific anti–factor Xa activity. Its pharmacokinetic properties allow for a simple, fixed-dose, oncedaily regimen of subcutaneous injection, without the need for monitoring. We examine the efficacy and safety of fondaparinux in Japanese patients. Methods: Patients received fondaparinux (5.0 or 7.5 mg, adjusted according to body weight, age, creatinine clearance) subcutaneously once-daily and given for until the use of vitamin K antagonists resulted in an international normalized ratio above 1.5. Results: Forty-two patients were included. 4 patients (9.5%) received fondaparinux in part on an outpatient basis. Standard therapy (fondaparinux to warfarin) had been used for 28 patients (66.7%) Switching from unfractionated heparin for 14 patients (33.3%). There was no recurrence of symptomatic venous thromboembolism. Treatment-related adverse events occurred in 4 patients (9.5%). Major bleeding occurred in 1 patient required blood transfusion and minor bleeding occurred in three patients treated with fondaparinux. Two patients died during the observation period, however all of them were cancer related death. Conclusions: Once-daily, subcutaneous administration of fondaparinux without monitoring is effective and safe in the initial treatment of VTE patients.
