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Rivaroxaban feasible for treatment of DVT
7 September 2010
MedWire News: Rivaroxaban, a direct oral factor Xa inhibitor, is as effective as treatment with enoxaparin plus warfarin in the prevention of recurrent venous thromboembolism (VTE) among patients with acute deep vein thrombosis (DVT), study findings indicate.
Speaking at the European Society of Cardiology 2010 Congress in Stockholm, Sweden, Harry Büller (Academic Medical Center, Amsterdam, The Netherlands) reported the findings of the multinational EINSTEIN-DVT study.
The study was designed to investigate the potential use of rivaroxaban as a replacement for standard therapy among patients with acute symptomatic DVT, but without concomitant symptomatic pulmonary embolism (PE).
In total, 3449 patients were randomly assigned to receive either oral rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg daily) or standard treatment with bodyweight-adjusted enoxaparin (1 mg/kg twice daily) followed by warfarin or acenocoumarol, dose adjusted to maintain a therapeutic international normalized ratio (range 2.0-3.0) for 3, 6, or 12 months, based on the physician’s assessment at baseline.
Büller reported that recurrent symptomatic VTE (DVT, fatal or non-fatal PE) occurred in 2.1% of the rivaroxaban recipients and 3.0% of the patients receiving standard therapy, demonstrating the non-inferior efficacy of rivaroxaban. In fact, rivaroxaban was associated with a 33% reduced risk for recurrent symptomatic VTE compared with the current standard treatment.
The EINSTEIN-DVT study also demonstrated similar rates of major and clinically relevant non-major bleeding for rivaroxaban compared with standard therapy (8.1% vs 8.1%). Furthermore, there was no evidence of liver toxicity.
“The results of the EINSTEIN-DVT trial indicate that rivaroxaban is an effective and safe treatment for acute symptomatic DVT,” said Büller.
He added: “The single-drug approach with rivaroxaban will provide clinicians and patients with an attractive, simple, alternative regimen for the initial and long-term treatment of DVT.”
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