Apixaban Beats Warfarin for Stroke Prevention, Lives Saved

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Warfarin has long been the standard drug administered to prevent stroke and systemic embolism in patients with atrial fibrillation, but there’s a new kid moving onto the block. Apixaban (Eliquis) is a new anticoagulant that has proven more effective than warfarin in a number of critical factors, including lives saved.

Apixaban is better tolerated than warfarin

Researchers from Duke University Medical Center announced their findings from ARISTOTLE, a randomized, double-blind clinical trial of apixaban, at the European Society of Cardiology gathering in Paris, France, and the news is significant. According to Christopher B. Granger, MD, professor of medicine at Duke and the study’s lead author, compared with warfarin, “apixaban resulted in an additional 21 percent relative reduction in stroke or systemic embolism.”

In addition, apixaban use also was associated with a 31 percent reduction in major bleeding and an 11 percent reduction in overall death. Hemorrhagic stroke was reduced by about 50 percent.

ARISTOTLE involved 18,201 patients enrolled from 39 countries. Participants were given either 5 mg twice daily of apixaban or warfarin for an average of 1.8 years.

This is not the first time apixaban has demonstrated its effectiveness in preventing stroke. In 2010, the drug was the focus of the AVERROES study, where it was tested in patients with atrial fibrillation who could not take warfarin.

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In the study, 5,600 patients were randomly assigned to take either apixaban or aspirin. The monitoring committee found a greater than 50 percent reduction in risk for stroke and systemic embolism. This study was the first to use apixaban in patients with atrial fibrillation.

About 15 percent of strokes are a result of untreated atrial fibrillation, and having atrial fibrillation increases a person’s risk of strike by about fivefold. Approximately 2.6 million Americans have atrial fibrillation, which is the most common type of irregular heartbeat.

John Alexander, MD, a cardiologist at Duke and a study co-author, noted other advantages of apixaban over warfarin. “It does not require monitoring and has few interactions with other medications or foods,” he explained. “Apixaban was better tolerated than warfarin, with fewer discontinuations.”

Use of warfarin requires patients to undergo regular blood tests to monitor their dose, and they must avoid certain foods and medications. Warfarin is also associated with an increased risk of intracranial hemorrhage.

Thus the findings of this latest study from Duke are significant, because “there is an enormous unmet need for treatment of patients at risk for stroke associated with atrial fibrillation,” according to Granger, and part of the reason is that warfarin has limitations.

Entry of apixaban into the treatment picture could mean better prevention of stroke and systemic embolism, lives saved, and no need for anticoagulation monitoring. Apixaban has not yet been approved for prevention of stroke or systemic embolism in patients with atrial fibrillation in any country.

SOURCES:
Duke University Medical Center
Pfizer press release, Aug. 28, 2011

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