New Real-World Analysis Finds Lower Risk of Major Bleeding and Similar Risk of Stroke with Standard Dose of Pradaxa® Compared to Rivaroxaban in NVAF Patients Newly Initiating Treatment

Ridgefield, Conn., Boehringer Ingelheim today announced results from a retrospective, observational real-world study assessing the safety and effectiveness of novel oral anticoagulants (NOACs) among patients with non-valvular atrial fibrillation (NVAF) treated through the U.S. Department of Defense Military Health System. The study examined major bleeding and stroke rates in NVAF patients who had initiated treatment with Pradaxa® compared to those treated with rivaroxaban or apixaban. The results were presented at the International Stroke Conference 2018 in Los Angeles, California.

“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said Todd C. Villines, M.D., Assistant Professor of Medicine at Georgetown School of Medicine, and lead investigator of the study. “As a researcher and treating physician I hope that this large-scale, U.S. practice-based comparison will provide additional insight on available NOAC therapies, including Pradaxa.”

The approved labelling for Pradaxa does not include data comparing the product to other NOAC therapies, and there are no clinical trials providing a head-to-head comparison of NOAC therapies. Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with NVAF.

The study analyzed data from NVAF patients newly initiating treatment with Pradaxa, rivaroxaban or apixaban. The study examined two cohorts: one that resulted in 12,763 propensity score matched Pradaxa (150 mg bid) and rivaroxaban (20 mg daily) patients, and another that resulted in 4,802 propensity score matched Pradaxa (150 mg bid) and apixaban (5 mg bid) patients. The primary outcomes for the study were risk of major bleeding and stroke.

Pradaxa patients demonstrated lower rates of major bleeding compared to rivaroxaban patients [2.08 percent (266/12,763) vs 2.53 percent (323/12,763); hazard ratio (HR) 0.82; 95 percent confidence interval (CI) 0.70-0.97; p=0.0182] and similar rates of stroke [0.60 percent (77/12,763) vs 0.78 percent (100/12,763); HR 0.77, CI 0.57-1.04; p=0.0844]. In the exploratory analysis, Pradaxa and apixaban patients showed similar rates of major bleeding [1.60 percent (77/4,802) vs 1.21 percent (58/4,802); HR 1.37, CI 0.97-1.94; p=0.0702] and stroke [0.44 percent (21/4,802) vs 0.35 percent (17/4,802); HR 1.26, CI 0.66-2.39; p=0.4892].

Limitations of the study include the potential for residual confounding as an observational, on-treatment study. The study also used data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited Pradaxa users available for matching with apixaban.

“There are countless factors to consider when choosing a medicine to treat a chronic condition. Assessing Pradaxa in the real-world setting, especially against other NOACs, is part of our responsibility to patients and physicians making those complex treatment decisions,” said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We believe that research and information are the most powerful tools physicians have to help them provide their patients with ideal care."