May 30, 2011
PRADAXA is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. PRADAXA lowers the chance of blood clots forming in your body.
The drug may prove a new option for patients who now use standard blood thinners such as warfarin to control the heart condition.
More than 2 million Americans have atrial fibrillation, which occurs when the heart's two upper chambers beat quickly and out of sync, the FDA said Wednesday in a news release.
Pradaxa (dabigatran) is an anti-clotting drug that inhibits an enzyme involved in blood clotting. Clinical studies of the drug found that when compared with warfarin, people with atrial fibrillation had fewer strokes on Pradaxa than those on warfarin, the FDA said.
One such trial was presented in February at the American Stroke Association annual meeting in San Antonio. It included more than 3,600 patients with atrial fibrillation and a previous stroke who were randomly chosen to receive warfarin, a low dose of Pradaxa (110 milligrams) twice a day or a higher dose (150 mg) of Pradaxa twice a day for about two years.
The rate of stroke or transient ischemic attack (TIA, often called "mini- stroke") in those taking warfarin was about 2.7% a year and 2.3% a year for those taking Pradaxa, not a significant difference.
However, the lower dose of Pradaxa caused less bleeding and was easier to manage than warfarin, a famously difficult drug to administer and monitor.
"In contrast to warfarin, dabigatran is given in a fixed dose twice daily independent of body weight, sex, food, whatever, and you don't need to monitor the coagulation system," study author Dr. Hans-Christoph Diener, chairman of neurology at University Hospital in Essen, Germany, said during a news conference held during the meeting.