Boehringer Ingelheim's Pradaxa Safe And Effective, FDA Study Reaffirms

Boehringer Ingelheim’s Pradaxa is safe and effective, according to a Food and Drug Administration (FDA) study of 134,000 patients. The company announced the results in a press release, stating that the oral anticoagulant showed a favorable benefit/risk profile. When compared to warfarin in patients with non-valvular atrial fibrillation (NVAF), Pradaxa (dabigatran etexilate mesylate) was more effective at reducing the risk of ischemic stroke, intracranial hemorrhage, and death. However, Pradaxa showed a significantly increased risk of major gastrointestinal hemorrhage, especially at the higher dose.

Boehringer Ingelheim is publishing the post-marketing study results in Circulation journal. Sabine Luik, MD, senior VP of Medicine & Regulatory Affairs at Boehringer Ingelheim, said, “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.”

FDA Pradaxa Study

The FDA released the results of its Pradaxa vs. Warfarin study on Medicare patients, stating that the study findings are consistent with the results of the studies that formed the basis for the Pradaxa approval, except for myocardial infarction (MI). In this study, MI rates were similar, whereas in the clinical trial results that were provided to the FDA to form its basis for Pradaxa’s approval, MI higher with Pradaxa, but not statistically significant. The new study, the federal agency says, is different from the previous studies in that it includes a “much larger and older patient population” and “a more sophisticated analytical method to capture and analyze the events of concern.” The FDA has concluded from the study that Pradaxa still has a “favorable benefit to risk profile.” The agency made no changes to the label or added any further guidance.

Stroke Treatments

Pradaxa may reduce the risk of stroke and systemic embolism in patients with NVAF. Boehringer Ingelheim and the FDA compared the drug to warfarin, because warfarin, a Vitamin K-inhibiting anticoagulant, was a leading treatment for NVAF. In its approval of Pradaxa for atrial fibrillation, the FDA stated that patients who took Pradaxa had fewer strokes than those who took warfarin. Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, highlighted another advantage of Pradaxa over warfarin, saying, “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.”