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New drug may be as effective as common blood thinner for stroke prevention


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American Heart Association Late-Breaking Clinical Trial Report LBCT 5/Abstract: 15039 (Hall E)

Study Highlights:

  • The new drug edoxaban may be as safe and effective as warfarin for stroke prevention in patients with atrial fibrillation.
  • In a large, international, multicenter study, edoxaban was associated with lower risks of bleeding compared with warfarin.

Embargoed until 10:45 a.m. CT/11:45 a.m. ET Tuesday, Nov. 19, 2013
This release is featured in an embargoed media briefing at 8:30 a.m. CT, Tuesday, Nov. 19.
DALLAS, Nov. 19, 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 late-breaking clinical trial presented at the American Heart Association’s Scientific Sessions 2013.

The ENGAGE AF-TIMI 48 Trial included more than 21,000 atrial fibrillation patients in 46 countries in 1,400 hospitals. 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 lose 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. “It inhibits the body’s ability to form a clot at a very critical juncture of the clotting pathway and behaves in a more predictable way.”

During the trial, the assigned dose of edoxaban was reduced for some patients based on their kidney function, body weight or because they were taking certain medications. Some patients who started out on the 60 mg of edoxaban were lowered to 30 mg, and some who began the study at 30 mg of edoxaban were switched to 15 mg.

Warfarin is the most common treatment for atrial fibrillation, 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 study edoxaban’s side effects, which patient populations may benefit most, develop standards for monitoring dosing and determine how best to quickly reverse its effects if needed in an emergency. Edoxaban is currently approved for use only in Japan in patients undergoing orthopedic surgery who are at risk for blood clots in the legs.

“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.”

Co-authors are C.T. Ruff, M.D.; E. Braunwald, M.D.; S.A. Murphy; S.D. Wiviott, M.D.; J.L. Halperin, M.D.; A.L. Waldo, M.D.; M.D. Ezekowitz, M.D.; J.I. Weitz, M.D.; J. Spinar, M.D.; W. Ruzyllo, M.D.; M. Ruda, M.D.; Y. Korestune, M.D.; J.M. Betcher; M. Shi; L.T. Grip; S.P. Patel; I. Patel, M.D.; J.J. Hanyok; M. Mercuri; and E.M. Antman, M.D., on behalf of the ENGAGE AF-TIME 48 Investigators.  Disclosures

Daiichi-Sankyo funded the study.

For more news from AHA Scientific Sessions 2013, follow @HeartNews #AHA13 on Twitter.


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Note: Actual presentation is 11:41 a.m. CT/12:41 p.m., Tuesday, Nov. 19, 2013 in Hall E.

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