Edoxaban Effective in Preventing Stroke, Reducing Bleeding and Cardiovascular Death in Patients With Atrial Fibrillation

According to the United States Centers for Disease Control and Prevention, over 800,000 Americans die each year from heart disease and stroke. Stroke is the leading cause of serious long-term disability and death in the US. In addition to lifestyle changes, medications such as anti-blood clotting drugs are helpful in the prevention of stroke.

A late-breaking clinical trial to be presented at the American Heart Association Scientific Sessions on November 19, 2013 and published simultaneously online in The New England Journal of Medicine, demonstrates that high- and low-dose edoxaban were at least as effective in preventing stroke or systemic embolism (blood clot), while significantly reducing bleeding and cardiovascular death, compared to warfarin.

"Our study findings represent good news for patients and health care providers," said Robert Giugliano, MD, SM, FACC, FAHA, BWH Cardiovascular Division, lead study author. "We believe that once-daily edoxaban represents a new, effective, safe and convenient treatment to prevent stroke for many patients with atrial fibrillation, with the benefits of less bleeding and cardiovascular death, compared to standard therapy with warfarin."

Edoxaban and warfarin are anti-blood clotting medications. Edoxaban is a once-daily oral factor Xa inhibitor currently being studied in clinical trials. Warfarin is a common drug prescribed to prevent the formation of blood clots, and has been the standard oral blood thinner for over five decades.

Led by the TIMI (Thrombolysis In Myocardial Infarction) Study Group at Brigham and Women's Hospital (BWH) and Harvard Medical School, the ENGAGE AF-TIMI 48 trial was the largest (21,105 participants) and longest (2.8 years average follow-up) trial of a novel anticoagulant to date in patients with atrial fibrillation. The study compared two dose-regimens of once-daily edoxaban versus warfarin.

Researchers recruited participants with atrial fibrillation (irregular heart rate) who were at moderate-to-high risk for stroke. The trial was conducted at 1,393 centers in 46 countries. Participants were enrolled from November 2008 to November 2010.

Prevent Stroke

Prevent stroke - the second single biggest killer and the leading cause of disability amongst adults in Australia

1 in 6 people will have a stroke - behind these numbers are real lives. Strokes can happen to anyone so it is important to know your stroke risk.

Stroke is not a heart attack. A stroke happens when the supply of blood to the brain is suddenly disrupted. Blood is carried to the brain by blood vessels called arteries.

Blood may stop moving through the artery because the artery is blocked by a clot or plaque, or because the artery breaks or burst. When blood stops flowing, the brain does not get the oxygen it needs, and so brain cells in the area die, and permanent damage can be done.