A U.S. Food and Drug Administration (FDA) study of more than 134,000 Medicare patients found that Pradaxa was associated with significantly reduced risks of ischemic stroke, intracranial hemorrhage and death, and a significantly increased risk of major gastrointestinal hemorrhage, compared with warfarin in patients with non-valvular atrial fibrillation (NVAF).The study found no difference in major bleeds or myocardial infarction with Pradaxa compared to warfarin. The study, which was published online in Circulation, further reinforces the favorable benefit/risk profile of Pradaxa, as shown in the pivotal RE-LY trial for stroke risk reduction in NVAF.
“This is the largest and most rigorous post-marketing study of Pradaxa in routine clinical practice and supports the positive risk/benefit profile of Pradaxa,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc. “Patient safety is of utmost importance and we are pleased to see these findings further support the value of Pradaxa a treatment option for NVAF patients”.
The FDA study is based on data from elderly patients older than 65 years enrolled in Medicare who started therapy with Pradaxa or warfarin between October 2010 and December 2012. Each group comprised 67,207 patients. The analysis showed that Pradaxa was generally associated with better patient outcomes compared to warfarin. The primary outcomes were:
•20% reduced risk of ischemic stroke.
•No difference in major hemorrhage.
•66% reduced risk of intracranial hemorrhage.
•28% increased risk of gastrointestinal bleeding.
•No difference in acute myocardial infarction.
The study also found the following secondary outcomes:
•14% reduced risk of mortality.
•No difference in all hospitalized bleeds.
The FDA had announced initial findings of their analysis in a Drug Safety Communication on its website in May 2014, stating that “As a result of our latest findings, we still consider Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.” This study was performed as part of the SafeRx Project, a joint initiative of the Centers for Medicare & Medicaid Services (CMS) and the FDA.
Date: November 4, 2014
Source: PR Newswire
Filed Under: Drug Discovery