Promising Results of Drug Trial Could Herald a Replacement for Popular Blood Thinner

˜First Breakthrough in 60 Years for Preventing Stroke in Patients with Atrial Fibrillation,' Says Dr. Michael Ezekowitz, Lankenau Cardiologist and Lead U.S. Researcher

WYNNEWOOD, Pa.--(BUSINESS WIRE)--Aug 31, 2009 - Researchers today published promising results for a drug that could lead to a replacement for the very effective but difficult-to-use blood thinner Coumadin® (sold generically as Warfarin), taken by millions of Americans to reduce their risk of stroke. In the New England Journal of Medicine, lead U.S. researcher, clinical cardiologist and Vice President of the Lankenau Institute for Medical Research Dr. Michael Ezekowitz hailed the study results as “the first breakthrough in 60 years for preventing stroke in patients with atrial fibrillation.”

The study by German pharmaceutical manufacturer Boehringer Ingelheim was the largest stroke prevention trial ever conducted among patients with atrial fibrillation. Involving 18,113 patients in 44 countries, the clinical trial compared the new drug, Dabigatran, to Warfarin.

“The magnitude of these results cannot be understated,” Dr. Ezekowitz said. “For years, the primary drug option cardiologists have had in preventing strokes in patients with atrial fibrillation is the anticoagulant Coumadin. Although it is highly effective, it is a very difficult to control.

“This study points to another solution that is potentially more effective and safer. This should be welcome news for patients with atrial fibrillation who are at risk for stroke.”

Atrial fibrillation, estimated to affect three million in the U.S., is the leading heart arrhythmia. It is caused by a malfunction of electrical signals that direct the heart's pumping action. The result is a rapid and chaotic contraction of the atria. Individuals often experience shortness of breath, fatigue and palpitations. In some cases, atrial fibrillation can lead to stroke.

Dr. Ezekowitz listed the following features of Dabigatran:

 

  • Like Coumadin, it can be taken by mouth, but unlike Coumadin – which takes four days to work – Dabigatran acts within two hours
  • Dabigatran, unlike Coumadin, has very few drug-to-drug interactions and, unlike Coumadin, does not require patient monitoring
  • Dabigatran is superior to Coumadin at the higher dose without compromising safety, and is safer than Coumadin at the lower dose without compromising effectiveness

According to Dr. Ezekowitz, “Another remarkable aspect is that we identified precisely the correct dosage of Dabigatran to give to patients. If the dosage of a blood thinner is too high, the patient can experience bleeding. If it's too low, a stroke can occur. This trial not only identified a drug that is more effective than Coumadin, it also revealed the precise dosage that needs to be administered.”

Additional information at http://www.LIMR.org and http://www.mainlinehealth.org/oth/Page.asp?PageID=OTH000886.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6039225&lang=en

 

Contact: Lankenau Institute for Medical Research
Tava Shanchuk
Office: 484-476-3429
Cell: 716-698-5865
shanchukt@mlhs.org
or
Buchanan Public Relations
Emily DiTomo
Office: 610-649-9292
Cell: 484-557-9318
emily@buchananpr.com

 

Posted: September 2009

View comments

Hide
(web2)