Phase III darexaban results revealed

Jul 10 2012

By Piriya Mahendra

The direct oral factor Xa inhibitor darexaban is effective for the prevention of venous thromboembolism (VTE) in Japanese patients undergoing major abdominal surgery, researchers find.

A Phase III study shows that patients treated with darexaban 15 mg twice daily had a 12-day VTE incidence of 2.6% compared with 15.0% in patients who were treated with mechanical prophylaxis (intermittent pneumatic compression and/or elastic stockings).

As reported in Thrombosis Research, the incidence of all bleeding events was 9.5% in the darexaban group compared with 3.9% in the mechanical prophylaxis group.

In the darexaban group, bleeding events that resulted in discontinuation occurred in five patients, of whom two had anastomotic hemorrhage, one had lower gastrointestinal hemorrhage, one had subcutaneous hemorrhage, and one had hemorrhoid hemorrhage.

By contrast, none of the patients in the mechanical prophylaxis group withdrew from the study due to bleeding events.

"All bleeding events in this study were resolved (with or without drug therapy), and were deemed clinically acceptable for this patient population requiring anticoagulant therapy," remark Masato Sakon (Nishinomiya Municipal General Hospital, Japan) and Mashio Nakamura (Mie University, Japan).

Overall, 74.1% of the darexaban group reported adverse events compared with 76.5% of the mechanical prophylaxis group. The most common adverse events reported were constipation and insomnia.

None of the patients died during the study.

The study comprised 117 Japanese patients aged at least 40 years who were randomly assigned to receive darexaban (n=77) or mechanical prophylaxis (n=40).

The incidence of VTE in Japan has steadily increased in recent years, with some studies reporting rates as high as 24.3%.

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