September 1st, 2013

Positive Results for Edoxaban in VTE/PE

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A new entrant in the growing oral anticoagulant field shows promise for the treatment of venous thromboembolism (VTE) and pulmonary embolism (PE). The drug, edoxaban, is a new, once-daily Factor Xa inhibitor with a rapid onset of action that is under development by Daiichi Sankyo. Results of the Hokusai-VTE trial were presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in the New England Journal of Medicine.

The Hokusai-VTE investigators randomized 4921 patients with VTE and 3319 patients with PE to either warfarin or edoxaban. The trial differed from some earlier trials with new oral anticoagulants in that patients were treated following a lead-in period with heparin. In addition, patients were treated for as short as three months or as long as a year at the discretion of the physician, though patients were followed for a full year. Patients with low body weight or renal impairment received a half dose of edoxaban. The investigators said the design was intended to reflect the full spectrum of conditions clinicians see in real life.

  • At one year, the primary efficacy outcome, recurrent symptomatic VTE, occurred in 3.2% of the edoxaban group and 3.5% of the warfarin group (HR 0.89, CI 0.70-1.13, p<0.001 for noninferiority).
  • Major or clinically relevant nonmajor bleeding occurred in 8.5% of the edoxaban group and 10.3% of the warfarin group (HR 0.81, CI 0.71-0.94, p=0.004 for superiority).
  • In the subset of 938 PE patients with right ventricular dysfunction, recurrent VTE was significantly lower in the edoxaban group (3.3% versus 6.2%, HR 0.52, CI 0.28-0.98).

Because it evaluated all patients at 12 months, regardless of treatment length, the investigators said that the trial design “allowed for a better understanding of the outcomes that may be expected in clinical practice.”

Primary results of the ENGAGE AF-TIMI 48 study of edoxaban in atrial fibrillation are scheduled to be presented in November at the American Heart Association meeting in Dallas.


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