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(HealthNewsDigest.com) – DALLAS, Sept. 8, 2011 — The American Heart Association notes the FDA advisory committee’s recommendation today to give market approval for rivaroxaban, an oral anticoagulant drug, for the prevention of stroke and blood clots in patients with atrial fibrillation.
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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