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Alternative to Warfarin May Cut Risk of Bleeding

Dabigatran etexilate does well in trial of atrial fibrillation patients

SUNDAY, Nov. 15 (HealthDay News) -- The anti-clotting drug dabigatran etexilate (Pradaxa) may be more effective and safer than warfarin at preventing clots and stroke in patients with atrial fibrillation, a new Swedish study has found.

Warfarin is effective in preventing blood clots that can cause stroke in patients with atrial fibrillation (abnormal heart rhythm) and other diseases, but the drug has a narrow therapeutic range in which it prevents strokes but doesn't cause bleeding, according to the researchers. This means that effective warfarin treatment requires regular laboratory monitoring to ensure warfarin levels remain in the range that lowers the risk of stroke without increasing the risk of bleeding.

This study included 18,113 atrial fibrillation patients in 44 countries who were randomly selected to receive either oral treatment with standard warfarin (6,022 patients) or dabigatran etexilate at either 110 milligrams (6,015 patients) or 150 milligrams (6,076 patients).

After one to three years of follow-up, 1.69 percent of patients in the warfarin group suffered a stroke or serious clot per year, compared with 1.53 percent and 1.11 percent of patients taking 110-milligram and 150-milligram doses of dabigatran etexilate, respectively, the study authors, from University Hospital in Uppsala, found.

Rates per year of major bleeding were 3.36 percent in the warfarin group and 2.71 percent and 3.11 percent for patients taking 110-milligram and 150-milligram doses of dabigatran etexilate, respectively.

The study was scheduled to be presented Sunday at the American Heart Association's annual meeting in Orlando, Fla.

The patients in the study were an average age of 72 and included some who'd suffered a prior stroke (13 percent), patients with high blood pressure (79 percent), those who'd never taken an oral anti-clotting drug for more than two months (50.4 percent), and those who weren't using an oral anti-clotting drug when they enrolled in the study (34 percent).

Dabigatran etexilate is approved for use in Canada and Europe but not in the United States.

More information

The American Academy of Family Physicians has more about atrial fibrillation.

-- Robert Preidt

SOURCE: American Heart Association, news release, Nov. 15, 2009

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