BI released dabigatran etexilate for the treatment of non-valvular atrial fibrillation real world research positive data

BI released dabigatran etexilate for the treatment of non-valvular atrial fibrillation real world research positive data

BI released dabigatran etexilate for the treatment of non-valvular atrial fibrillation real world research positive data

January 26, 2018 Source: Sina Pharmaceutical

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On January 25, Boehringer Ingelheim (BI) announced a retrospective and observational real-world study that was used by the US Department of Defense's military health system for new oral anticoagulants (NOACs). The safety and efficacy of treatment in patients with non-valvular atrial fibrillation (NVAF) was evaluated. The study compared the incidence of major bleeding and stroke in patients receiving NVAF with Pradaxa (dabigabate mesylate) compared with patients receiving rivaroxaban or apixaban. This result was announced at the International Stroke Conference in Los Angeles, California in 2018.

Dr. Todd C. Villines, MD, assistant professor of medicine at Georgetown Medical School and chief researcher of the study, said: "As more and more Americans with atrial fibrillation begin to receive NOAC treatment, compare drugs like this one. Real-world analysis of effectiveness and safety will become very important. As a researcher and treating physician, I hope that this large-scale, comparative study based on US medical practice can provide more about NOAC therapy (including Pradaxa)."

The approved Pradaxa specification does not include data on this product compared to other NOAC treatments, and there are currently no clinical trials that provide a head-to-head comparison of the NOAC treatment regimen. Pradaxa reduces the risk of stroke and systemic embolism in NVAF patients.

The study analyzed data from NVAF patients who had just started using Pradaxa, rivaroxaban, or apixaban, and performed two cohort analyses: 12,763 patients with Pradaxa (150 mg twice daily) and rivaroxaban (20 mg daily) Patient cohort and a cohort of patients with Pradaxa (150 mg twice daily) and apixaban (5 mg twice daily) in 4802 patients. The primary goal of the study was the risk of major bleeding and stroke.

Compared with patients treated with rivaroxaban, patients receiving Pradaxa had a lower risk of major bleeding [2.08%, (266/12763) vs 2.53% (323/12763), hazard ratio (HR) 0.82; 95% (CI) 0.70-0.97 ;p=0.0182], and stroke risk was similar [0.60% (77/12763) vs 0.78% (100/12763); HR 0.77, CI 0.57-1.04; p=0.0844]. In the exploratory analysis, the rate of major bleeding was similar in Pradaxa and apxaban patients [1.60% (77/4802) vs 1.21% (58/4802); HR 1.37, CI 0.97-1.94; p=0.0702], and the stroke rate was similar [0.44 %(21/4802) vs 0.35%(17/4802); HR 1.26, CI 0.66-2.39; p=0.4892].

Limitations of this study include the possibility of classifying residual confounding into observational, therapeutic studies. The study also used data from electronic health records, which may not be the best approach to determining baseline risk and outcome. Finally, the number of Pradaxa users who can match apixaban patients is limited.

Dr. Sabine Luik, Senior Vice President of Medical Affairs at Boehringer Ingelheim, said: "There are countless factors to consider when choosing drugs for chronic diseases. In the real world, we evaluate Pradaxa and other NOACs, which we make for patients and doctors. One of the responsibilities of complex treatment decisions. We believe that research and information analysis data are the most powerful tools doctors have to help them provide the ideal care for their patients. (Sina Medical Compilation/David)

Article Reference Source: 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

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