Pradaxa Approved to Fight Dangerous Irregular Heartbe... (ransient ischemic attack or stroke and s...)

Pradaxa Approved to Fight Dangerous Irregular Heartbeat, Stroke

Date:10/20/2010

ransient ischemic attack or stroke and suffer from atrial fibrillation, dabigatran is as effective as warfarin," he added. "And it's much easier to handle."

Patients receiving Pradaxa had more heart attacks than those taking warfarin, but the absolute difference was small, the authors stated. Also, Pradaxa patients had higher rates of gastrointestinal bleeding.

The study was funded by Boehringer-Ingelheim GmbH, which makes the drug.

Those findings were echoed by a study published last year in the New England Journal of Medicine. In that trial, also funded by the drugmaker, Pradaxa proved equal to warfarin in preventing dangerous venous clots, but much easier for doctors and patients to manage.

"For patients and health-care providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs and therefore does not require routine blood-coagulation testing," wrote the international team of researchers led by Dr. Sam Schulman of McMaster University and the Henderson Research Center in Hamilton, Ontario, Canada.

And last November, two other promising reports on Pradaxa were presented at the American Heart Association meeting in Orlando. Those studies found the drug to be safe and effective in preventing blood clots when patients were treated for acute coronary syndrome, a cluster of symptoms that might indicate a heart attack. It was also found superior to warfarin in preventing strokes in patients with atrial fibrillation.

Pradaxa, which is produced in 75 milligram and 150 milligram strengths, is not without side effects or risk, however. According to the FDA, as with other anti-clotting drugs, a potential side effect is life-threatening bleeding. Other potential adverse reactions include stomach discomfort or pain, nausea, heartburn and bloating.

"It's premature to say that a drug like dabigatran will take the place of warfarin,"
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