New Anticoagulant Pill Works Well in Trial
In March, a U.S. Food and Drug Administration advisory panel voted 15-2 that rivaroxaban, a long-sought alternative to commonly used blood thinners that have to be injected and are tricky to monitor, had benefits that outweighed its bleeding risks. Although the FDA is not bound by the panel's decision, it typically follows suit on these recommendations.
For the study, Mega's group treated 3,491 patients who had had heart attacks or unstable angina with either aspirin or aspirin plus the anti-clotting drug clopidogrel (Plavix).
The patients were then randomly assigned to a placebo or rivaroxaban, at doses ranging from 5 milligrams to 20 milligrams a day. The researchers looked for any significant bleeding and deaths, heart attacks and stroke.
There was an increase in bleeding episodes with rivaroxaban. Over six months, the researchers found that risk increased with dosage. At 5 milligrams, the risk increased 2.2 times, while the 20-milligram dose raised the risk fivefold.
However, patients receiving rivaroxaban had a 21 percent reduction in heart attacks, strokes, ischemic events and deaths compared with patients taking placebo.
Add A New Comment
Add A New CommentComments
There are no comments yet. Be the first to get the conversation started.