BRIEF—New real-world analysis assesses Pradaxa risks

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 US Department of Defense Military Health System.

The study examined major bleeding and stroke rates in NVAF patients who had initiated treatment with the German drug major’s Pradaxa (dabigatran etexilate mesylate) compared to those treated with rivaroxaban or apixaban. The results were presented at the International Stroke Conference 2018 in Los Angeles, California.

Todd Villines, Assistant Professor of Medicine at Georgetown School of Medicine, and lead investigator of the study, said: “As a researcher and treating physician I hope that this large-scale, US 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.

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