A study shows that risk reductions experimental stroke drug
The investigational drug reduces the risk of stroke in patients with irregular heart beat more than tripled compared to warfarin party drug - but perhaps at a price, according to a new study published Sunday.
Patients who took the new drug dabigatran, manufactured by German pharmaceutical company Boehringer Ingelheim, a little more heart attacks or abdominal pain, according to research presented at the European Society of Cardiology in Barcelona.
Patients with irregular heartbeats are five times more likely than a stroke in healthy people.
Approximately one sixth of all strokes occur in patients with cardiac arrhythmia, the risk factors like smoking or obesity. In the U.S. there are about 2 million people with this condition.
Until now, most of these patients are warfarin, which have been around since the 1950s, and has side effects such as bleeding risk and changes in lifestyle were necessary because of dietary restrictions.
Doctors hope the new drug can improve treatment for patients who need to be continuously monitored when they were put on warfarin and avoid alcohol and foods such as spinach and cranberries.
The new study of dabigatran created - which has not yet been approved in the United States, but as Pradaxa sold in 40 countries to prevent clotting - after doctors more than 18,000 patients with atrial fibrillation, or rhythm irregular heartbeat in the world for some two years followed, beginning in 2005. Patients took either warfarin or etexilate, in different dosages.
On warfarin in a patient reduces the risk of stroke dramatically to about 0.38 percent per year, according to the study, also published online in The New England Journal of Medicine. Complications of warfarin have been invited, but because it is difficult to dose and are confusing for patients to use, doctors said.
Dabigatran, the risk is further reduced to about 0.10 percent per year, says the study.
"It's certainly a big step forward," said Dr Fausto Pinto, director of the Institute of Cardiology, University of Lisbon, Portugal, and program chair of the European Society of Cardiology.
Dabigatran "could replace warfarin," because it is easier for physicians and patients to use, "said Pinto, who is not involved in the study.
Last year, the market for anti-clotting drug was about 13.6 billion U.S. dollars worldwide.
Obtain approval of dabigatran could take years for Boehringer Ingelheim, data submitted to regulatory agencies.
Dr. Clyde Yancy, medical director of the Baylor Heart and Vascular Institute in Dallas and president of the American Heart Association, said more information on the reasons for dabigatran seemed slightly increased the number of heart attacks are, but in the Overall, the data were encouraging.
"The patient wants a little easier for their atrial fibrillation to take years, and it may be," said Yancy. "Therefore, this may be changing all that.
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