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Anti-Clotting Drug May Cause Severe Bleeding With No Benefit
Date:7/25/2011

By Steven Reinberg
HealthDay Reporter

SUNDAY, July 24 (HealthDay News) -- For patients suffering chest pain, adding a new anti-clotting drug, Eliquis, to dual antiplatelet therapy may result in severe bleeding without reducing the risk of heart attack and stroke, a new study finds.

A trial evaluating the combination treatment was halted early when the risk of severe bleeding among those taking Eliquis (apixaban) became apparent.

"It is very clear there is an increased risk of bleeding, and in most patients it doesn't appear there is a lot of benefit to outweigh the risk of bleeding," said researcher Dr. John H. Alexander, co-director of cardiovascular research at the Duke Clinical Research Institute of Duke University Medical Center in Durham, N.C.

"We know high-risk patients with acute coronary syndromes continue to have events, and we know antiplatelet therapy is effective," said Alexander. The researchers expected to see some increase in bleeding when they added Eliquis to other anti-clotting therapy, but the bleeding was significant and "there was nothing to offset that increase in bleeding, so we stopped the trial," he said.

The conclusion: "Combination treatment with an anticoagulant and dual antiplatelet therapy should be avoided unless there is a clear indication for both, as in some patients with atrial fibrillation," Alexander said.

The report was published online July 24 in the New England Journal of Medicine to coincide with presentation of the study results at the International Society on Thrombosis and Haemostasis Congress, July 23-28 in Kyoto, Japan.

For the study, researchers randomly assigned 7,392 patients who were receiving standard antiplatelet therapy with two drugs to an additional 5 milligrams of Eliquis or a dummy pill twice daily. The study was double-blind, meaning that neither the patients nor the researchers knew who was taking Eliquis or a dummy pill.


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