Padaxa reduced cardiovascular mortality by 27% compared with warfarin.
New data suggest that Padaxa (dabigatran etexilate mesylate) can improve real-world safety and efficacy in patients with non-valvular atrial fibrillation compared with warfarin, according to a press release from Boehringer Ingelheim.
Padaxa demonstrated a lower risk of stroke and bleeding in patients with atrial fibrillation compared with warfarin, according to a presentation at the International Stroke Conference 2017.
Included in the study were 7245 patients treated with Pradaxa and 14,490 patients treated with warfarin who had not previously been treated with an oral anticoagulant. Data were gathered from a claims database between October 1, 2010 and April 30, 2014. Patients were mostly male, with a mean age of 74, and a mean stroke risk score of 2.2.
Compared with warfarin, treatment with Pradaxa was linked to a 26% reduced risk of stroke in patients with atrial fibrillation. Additionally, patients treated with Pradaxa had a 20% reduced risk of major bleeding, which is a common side effect of anticoagulants. Bleeding risks can be serious and sometimes fatal in patients taking anticoagulants. Since Pradaxa reduced the risk of bleeding, certain patients may benefit from taking the drug over other anticoagulants.
Boehringer Ingelheim also reported that Pradaxa was observed to lower risk for serious secondary outcomes. These patients saw a 68% reduction in the risk of hemorrhagic stroke, an 18% reduced risk of brain bleeds, and a 48% reduced risk of venous thromboembolism.
Overall, the investigators found that treatment with Pradaxa reduced mortality risk by 27% compared with warfarin, which was significant.
Pradaxa is an anticoagulant indicated to prevent stroke blood clots in patients with atrial fibrillation and to treat blood clots in patients with deep vein thrombosis or pulmonary embolism. Common adverse events include gastritis-like symptoms and bleeding.
Real-world data can provide insight into how the drug performs outside of controlled clinical trials, where use of the drug is carefully monitored. These real-world outcomes show Pradaxa’s superiority to treatment with warfarin, and may provide patients and physicians with additional information to consider when making treatment decisions for non-valvular atrial fibrillation.
“By combining our deep understanding of the patient journey with access to robust real-world data, we are improving the understanding of treatment for patients with chronic conditions such as NVAF,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “These data offer valuable real-world insights on patient outcomes, and are an important complement to our robust clinical trial program, in which Pradaxa demonstrated superior efficacy and a favorable risk-benefit profile compared to warfarin.”