The FINANCIAL — Bristol-Myers Squibb Company and Pfizer announced the results of the Phase 3 ADOPT trial, which evaluated apixaban versus enoxaparin in acutely ill medical patients, did not meet the primary efficacy outcome of superiority to enoxaparin for the endpoint of venous thromboembolism and VTE-related death at day 30.
The apixaban arm had a 13 percent lower rate of events than enoxaparin followed by placebo, which favored apixaban but was not statistically significant and thus no clinically directive conclusion can be drawn. The key safety outcome of major bleeding was low in both groups but occurred in more patients treated with apixaban than with enoxaparin . The study results were presented during a late-breaking session at the annual American Heart Association Scientific Sessions in Orlando, FL, and published in the New England Journal of Medicine.
“Solving the problem of VTE post-hospitalization remains a critical unmet need in preventing medically ill patients from developing deep vein thrombosis and pulmonary embolism,” said Dr. Samuel Z. Goldhaber, senior cardiologist at Brigham and Women’s Hospital, and Professor of Medicine, Harvard Medical School, Boston, MA. “ADOPT provides important insights for clinical trialists designing studies of extended duration VTE prophylaxis among medically ill hospitalized patients."
ELIQUIS , a new oral direct Factor Xa inhibitor, is part of a class of agents being studied for their potential to prevent and treat blood clots in multiple indications. ELIQUIS is currently approved in the 27 countries of the European Union for the prevention of VTE in adult patients who have undergone elective total hip or knee replacement surgery.
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