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Pradaxa Clinical Trial Analysis Sees Higher Heart Attack Risk

Jan 10, 2012 | Parker Waichman LLP

A new study is raising more concerns about Pradaxa. According to researchers from the Cleveland Clinic, people taking Pradaxa may be at a higher risk of suffering heart attacks and chest pain.

The large study used to gain Pradaxa its 2010 approval did hint at a small increased risk of heart attack among people taking the medication, according to The Wall Street Journal.   Since then, researchers have been trying to determine if Pradaxa does pose an increased risk.

In conducting this study, the Cleveland Clinic researchers analyzed data from seven Pradaxa clinical trials. All of the studies compared patients taking Pradaxa to those taking other blood thinners or a placebo.  The study found that Pradaxa boosted the risk of a heart attack and a condition known as acute coronary syndrome by 33%.  ACS encompasses both heart attacks and chest pain. The added risk for any one individual of having a heart attack if on Pradaxa - known as the absolute increased risk - was 0.27 percent.

"For persons with atrial fibrillation, dabigatran has a favorable benefit-risk profile, but for other uses the risk of heart attack has to be taken into account," said lead researcher Dr. Ken Uchino, director of the Vascular Neurology Fellowship Training Program at the Cleveland Clinic.

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