NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) Saturday announced positive results from a Phase 3 trial that studied ELIQUIS compared with placebo in patients for the prevention of recurrent venous thromboembolismin.
The Phase 3 study involved 2,486 patients who had already completed 6 to 12 months of anticoagulation treatment for venous thromboembolismin, or VTE, including deep vein thrombosis or pulmonary embolism. The study asssessed treatment with ELIQUIS over a one-year period compared with placebo.
In the trial, extended treatment with ELIQUIS 2.5 mg and 5 mg twice daily, demonstrated superiority versus placebo in the reduction of the composite endpoint of symptomatic, recurrent VTE, and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the ELIQUIS 2.5 mg and 5 mg groups, respectively) - the primary efficacy outcome of the trial and was statistically significant.
The rate of the primary safety outcome of major bleeding was comparable across treatment groups. The rate of the composite of major bleeding and clinically relevant non-major bleeding for the 5 mg treatment group (4.3%) was higher versus the placebo group (2.7%), while the rate for the 2.5 mg treatment group (3.2%) was similar to the placebo group.
The findings were published online today in The New England Journal of Medicine and announced at a press briefing during the 54th Annual Meeting of the American Society of Hematology (ASH).
VTE encompasses two serious conditions: deep vein thrombosis, a blood clot in a vein, usually in the leg, that partially or totally blocks the flow of blood; and pulmonary embolism, a blood clot blocking one or more vessels in the lungs.
VTE continues to be a major cause of morbidity and mortality, with approximately 900,000 patients in the U.S. and approximately 1 million patients in the EU diagnosed every year.
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