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    Rivaroxaban helps lower risks in acute coronary syndrome patients, study finds

    Rivaroxaban (Xarelto, Janssen Pharmaceuticals), an oral anticoagulant that directly inhibits factor Xa, reduced the risk of death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS), according to a report presented at the American Heart Association's Scientific Sessions 2011, Orlando, Fla. The study was also published in the New England Journal of Medicine and online.

    Researchers analyzed data from more than 15,000 hospitalized patients who had a recent ACS. Study participants were randomized to receive either standard of care plus twice-daily doses of either 2.5-mg or 5-mg rivaroxaban or standard of care and placebo. Patients received treatment for a mean of 13 months and up to 31 months.

    "Rivaroxaban significantly reduced the primary efficacy end point of death from cardiovascular causes, myocardial infarction, or stroke, as compared with placebo, with rates of 8.9% and 10.7%, respectively," the researchers reported.

    The anticoagulant was also able to reduce the risk of death, including all causes of death, by more than 30%, and stent thrombosis was reduced by 31% in patients who received rivaroxaban compared to patients who didn't receive the therapy. However, as with other types of anticoagulants, more internal bleeding occurred among those taking rivaroxaban than those who received placebo. The increase in TIMI major bleeding for patients receiving rivaroxaban was significant compared with placebo, with rates of 2.1% and 0.6%, respectively. But there was no significant different in the rates of fatal bleeding associated with patients taking rivaroxaban as compared with placebo (0.3% vs. 0.2%).

    "Our findings are important because blocking the production of thrombin is an important new way to improve acute coronary syndrome patients' long-term risk of death, stroke, and heart attack after being hospitalized with an acute coronary syndrome," said C. Michael Gibson, MD, senior investigator of the TIMI Study Group, Harvard Medical School, and the principal investigator in the ATLAS ACS studies of rivaroxaban for this indication.

    In July 2011 FDA first approved rivaroxaban to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery. In early November 2011, rivaroxaban was approved by FDA to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Xarelto is the only oral anticoagulant approved in the United States that offers once-daily dosing, without the need for routine blood monitoring.
     
    “The approval of Xarelto offers physicians a new option to reduce stroke risk in patients who are living with atrial fibrillation, and the continuous threat of strokes,” Gerald V. Naccarelli, MD, professor of medicine, chief of division of cardiology, Pennsylvania State University College of Medicine and Milton S. Hershey Medical Center, said in a company release. “A majority of my atrial fibrillation patients are on multiple medicines for conditions that further increase the risk of stroke. I welcome a therapy like Xarelto that has demonstrated effectiveness and safety in these patients, with the added convenience of a once-daily dose.”
     
    Xarelto is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation at a dose of 20 mg once daily, or 15 mg once daily for patients with moderate-to-severe renal impairment, taken with the evening meal. There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.
     
    Atrial fibrillation (AFib) is the most common cardiac rhythm disorder and affects more than 2.2 million people in the United States. In patients with AFib, the heart’s irregular heartbeat makes them vulnerable to the formation of a blood clot in the atria, which sometimes can break off and travel to the brain, potentially resulting in a stroke. The presence of common conditions such as high blood pressure, heart failure, diabetes, and prior stroke, along with being over aged 75 years, are factors that further increase the risk of stroke in people living with AFib. People living with AFib are at a 5-fold increased risk for stroke compared with the general population.  
     

    The approval of Xarelto in this indication was based on the pivotal, double-blind phase 3 ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation) global clinical trial, in which once-daily rivaroxaban effectively reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with major bleeding rates comparable to warfarin. In bleeding categories of great concern, such as bleeding into a critical organ and fatal bleeding, fewer events were observed with rivaroxaban. In the categories of bleeding resulting in transfusions and gastrointestinal bleed, more events were observed with rivaroxaban. To see the details of the ROCKET AF trial published in the New England Journal of Medicine, click here.