Prevention of Venous Thrombosis in Other Clinical Settings

Additional clinical studies have examined the utility of fondaparinux in the prevention of VTE following general surgery and in the medical patient. In general surgery patients, the PEGASUS study compared the efficacy of 2.5 mg fondapar-inux versus dalteparin administered preoperatively and then once daily at a dose of 5000 IU (Agnelli et al., 2005). The primary endpoint was venographically evident DVT and symptomatic VTE to day 10. The objective of this non-inferiority study was met, without a significant increase in major hemorrhage, prompting approval of fondaparinux by the FDA for the prevention of VTE following abdominal surgery.

In a population of medically ill patients, fondaparinux was compared to placebo in the prevention of venographically detected DVT and symptomatic VTE to day 15 of blinded therapy (Cohen et al., 2006). This international study of 849 patients illustrates the activity of fondaparinux in medical thromboprophylaxis, with a reduction in symptomatic and venographically evident VTE. The approval for fondaparinux in this clinical setting is under review.

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