Pradaxa Data Questioned in BMJ, Boehringer Ingelheim Responds

Boehringer Ingelheim has issued a statement regarding a recent article published in BMJ on the use of Pradaxa (dabigatran etexilate mesylate) and monitoring of anticoagulant activity and plasma levels.

The BMJ article states that Pradaxa is part of a new generation of oral anticoagulants indicated to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF); these new anticoagulants have been recommended in guidelines from Canada, Europe, and the U.S. over older treatments like warfarin because they do not require plasma level or anticoagulant activity monitoring and subsequent dose adjustment. However, BMJ asserts that Boehringer Ingelheim withheld from regulators analyses that calculated how many major bleeds dose adjustment can prevent. Internal Boehringer Ingelheim documents revealed that if the plasma levels of Pradaxa were measured and the dose adjusted accordingly, major bleeds could be reduced by 30–40% compared to warfarin with little to no effect on the risk of ischemic stroke. The plasma levels at which the dose adjustment should occur to reduce the risk of a major bleed were also noted in the documents.

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In response, Boehringer Ingelheim claims that the allegations made by BMJ were reported months ago in the media and have been previously addressed by the company. The company has provided regulators with complete data and analyses of clinical evidence demonstrating Pradaxa’s benefits and safety. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have confirmed the Randomized Evaluation of Long-term anticoagulant therapY (RE-LY) Trial conclusions and determined that Pradaxa provided important health benefits when used as directed.

In 2012, researchers at Boehringer Ingelheim performed preliminary, exploratory simulations with mathematical models to understand whether dose adjustments based on plasma concentrations might further improve Pradaxa’s benefits and safety. The simulations did not provide reliable predictions of actual patient outcomes so they were not provided to regulators. However, all of the data that was used for the simulations had already been provided. Boehringer Ingeleim states that it is inappropriate to provide regulators simulations that are unreliable and have limitations.

Pradaxa is a direct thrombin inhibitor indicated to reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF), as treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients treated with parenteral anticoagulant for 5–10 days, and to reduce risk of recurrent DVT/PE in patients who have been previously treated.

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