06:21pm Wednesday 18 October 2017

AHA perspective on FDA committee decision on Rivaroxaban

Atrial fibrillation is the most common form of irregular heartbeat, which carries a substantially increased risk of stroke.
“For the millions of patients with atrial fibrillation, stroke is a real health threat, and the emerging studies of new anticoagulant drugs like rivaroxaban has been very encouraging,” said Gordon Tomaselli, M.D. president of the American Heart Association. “However, it’s too soon to predict the overall impact that rivaroxaban or similar drugs will have on patients until these new drugs are used more widely.”
 
Rivaroxaban is one of several new anticoagulant drugs being studied as alternatives to warfarin, the main anti-clotting medication used for more than 50 years. Warfarin is challenging to use – healthcare providers must take frequent blood tests and adjust the dosage based on those results, and patients have to realize that certain drugs and foods may interact with warfarin, changing its blood-thinning effect.
 
With any anticoagulant drug, including the new drugs being studied, patients may face the risk of excessive bleeding or of the medication having an inadequate effect. Another issue that must be considered for each patient is how quickly the anticoagulant effect wears off when the drug is stopped and whether the effect can be reversed if bleeding or a need for emergency surgery emerges.
 
In its review, the FDA committee reviewed results from the ROCKET-AF trial, a study of rivaroxaban in patients with atrial fibrillation, presented at the American Heart Association’s 2010 Scientific Sessions meeting. This presentation suggested that rivaroxaban was not inferior to warfarin in preventing strokes and blood clots, without showing an increased bleeding risk. However, the study fell short of proving the superiority of rivaroxaban to warfarin.
 
The American Heart Association’s does not yet have guideline recommendations on the use of rivaroxaban – these will be based on the final FDA decision.
An estimated 2.2 million people are living with atrial fibrillation. About 15 percent to 20 percent of people who have strokes have this arrhythmia.
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The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding External link.
 
CONTACT:
Tagni McRae: (214) 706-1383; Tagni.McRae@heart.org
Julie Del Barto (broadcast): (214) 706-1330; Julie.DelBarto@heart.org
General inquiries: (214) 706-1396

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