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Study Sees More Side Effects from Pradaxa

Filed May 9th, 2012 Laurie

At the Thrombosis and Hemostasis Summit of North America on May 4, Alere Inc. announced preliminary results from the largest study comparing Coumadin and Pradaxa therapies administered in a real-world setting.

Mark Wurster, MD, and his team of researchers found that complications necessitating therapy discontinuation occurred more often with Pradaxa than it did with Coumadin. Also, Pradaxa-related complications occurred more quickly than Coumadin-related complications.

Pradaxa is the first oral thrombin/Xa inhibitor cleared for use by the FDA in the United States. The medication, which has been on the market since 2010, is used for the prevention of thromboembolic complications related to atrial fibrillation. There were many pre-approval studies conducted on the drug, but studies of the drug used in real-world therapy are few and far between. There is also very little information available about the frequency of side effects or complications for patients on Pradaxa, especially in comparison to patients taking Coumadin.

The “Dabigatran in the Real World” study is still active and the final report will include information on major contributing factors like renal function, co-morbid conditions, and concomitant medication use. Dr. Wurster is set to host a webinar to discuss the study’s conclusions, including that Coumadin is still an affordable, safe, and effective options for patients, on Wednesday, May 23.

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