Treatment of VTE

The treatment of VTE was assessed in two large, international studies (Buller et al., 2003, 2004). The primary outcome measure for both non-inferiority studies was the incidence of symptomatic VTE during a total treatment period of 3 mo.

TABLE 2 Indications for the Use of Fondaparinux

Indication

Dose and administration

U.S. approval

Venous thromboembolism prevention Hip fracture

Elective hip or knee replacement

Abdominal surgery

Medical

2.5 mg/d sc o.d. for up to 32 days 2.5 mg/d sc o.d. for up to 11 days 2.5 mg/d sc o.d. for up to 10 days 2.5 mg/d sc o.d.

Yes Yes Yes

Under review

Venous thromboembolism treatment Acute treatment of deep vein thrombosis or pulmonary embolism

5mg (<50 kg), 7.5 mg (50-100 kg), Yes or 10 mg (>100 kg) sc o.d. in fixed weight adjusted dose for minimum of 5 days and until INR & 2.0 on two occasions 24 h apart

Acute coronary syndrome

Unstable angina/non-ST elevation MI ST elevation MI

2.5 mg/d sc o.d. for 8 days 2.5 mg/d iv bolus followed by 2.5 sc o.d. for 8 days

Under review! Under review!

a a aUndergoing expedited review by the Food and Drug Administration as of March 2007.

Abbreviations: INR, international normalized ratio; MI, myocardial infarction; o.d., once-daily; sc, subcutaneous; iv, intravenous.

In MATISSE-DVT, patients with acute DVT were randomized to receive either sc fondaparinux, given once daily, or enoxaparin, given twice daily at a dose of 1 mg/kg. Patients in both arms of the study were transitioned to vitamin K antagonist therapy for the remainder of the protocol. There was no significant difference in efficacy (fondaparinux 3.9%; enoxaparin 4.1%) or tolerability.

In MATISSE-PE, patients with symptomatic acute pulmonary embolism were randomized to once-daily sc fondaparinux versus standard therapy with UFH. Again, all patients were transitioned to oral therapy with a vitamin K antagonist. The incidence of recurrent VTE was not significantly reduced in patients treated with fondaparinux (3.8%) compared to UFH (5.0%). Notably, patients with a serum creatinine over 2.0mg/dL were excluded from this study, which leaves some uncertainty regarding the tolerability of fondaparinux in patients with severe renal dysfunction. Based on the favorable results of the MATISSE studies, fondaparinux was approved for the treatment of VTE (Table 2).

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