A New Alternative to Warfarin

A new drug not yet available in the United States was as effective in preventing strokes and safer than the blood-thinner warfarin in patients with atrial fibrillation, according to a clinical trial presented at the American Heart Association’s Scientific Sessions 2013.



 

A new drug not yet available in the United States was as effective in preventing strokes and safer than the blood-thinner warfarin in patients with atrial fibrillation, according to a clinical trial presented at the American Heart Association’s Scientific Sessions 2013.

The ENGAGE AF-TIMI 48 Trial included more than 21,000 a-fib patients in 1,400 hospitals in 46 countries. Participants were randomly assigned to receive a high dose of edoxaban at 60 milligrams (mg) per day, a low dose of edoxaban at 30 mg per day or warfarin.

Edoxaban performed as well as warfarin in preventing strokes, while significantly reducing the risk of bleeding and cardiovascular disease-related death.

  • Compared with warfarin, major bleeding was 20 percent lower among patients taking the high dose of edoxaban and 53 percent lower among those taking the low dose.
  • Compared with warfarin, the high dose of edoxaban was associated with a 14 percent reduction in cardiovascular death; the low dose was associated with a 15 percent reduction.

Instead of depleting the body’s clotting proteins like warfarin, edoxaban singles out one key clotting protein called Xa to prevent clots.

“Edoxaban is a more targeted, simpler approach to preventing blood clots,” said Robert P. Giugliano, M.D., lead author of the study and a researcher and physician at Brigham and Women’s Hospital in Boston.

Warfarin is the most common treatment for atrial fibrillation, or a-fib, an irregular heartbeat that can increase the risk for stroke. Determining the right dose of warfarin may require multiple blood tests; too much may increase the risk for bleeding and too little can increase the risk of blood clots.

Researchers will continue to study edoxaban’s side effects and determine which patient populations may benefit most. They will develop standards for monitoring dosing and determine how best to quickly reverse its effects if needed in an emergency.

“Atrial fibrillation is a common problem among the elderly, and as Americans live longer we need safer, yet effective treatments,” Giugliano said. “Once-daily edoxaban may be an important alternative to warfarin.”

See full press release

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