Aug. 10, 2011 -- The newly approved drug Xarelto appears to prevent strokes at least as well as the standard treatment warfarin in people who have a heart condition that puts them at high risk for blood clots, a study shows.
Xarelto was approved by the FDA in July to prevent dangerous blood clots in people having hip and knee replacement surgery.
Next month, a panel of experts will consider whether the agency should also approve its use as a once-daily treatment for atrial fibrillation.
Atrial fibrillation causes the heart to pump in an irregular, uncoordinated way that may allow blood to pool and clot in its upper chambers. Those clots can travel to the brain, causing a stroke.
"Warfarin, which we found in the '50s and '60s, is a very good drug in preventing stroke, but it's sometimes difficult to use," says study researcher Manesh R. Patel, MD, a cardiologist at Duke University.
Because it works by blocking vitamin K, foods that are high in that nutrient, like dark leafy greens, can make warfarin less effective. A host of other medications including some antibiotics and painkillers can interact with the drug, blocking or enhancing its effect.
Doctors typically require patients on warfarin to get monthly blood tests to make sure it's working properly and "not making the blood too thick or too thin, so to speak," Patel says.
Patients were randomly assigned to take either a daily dose of warfarin or Xarelto. To prevent people from knowing which treatment they were getting, both groups were also assigned to take a placebo pill.