Boehringer plans new real-world data on Pradaxa

Five years on from the first breakthrough presentation of the pivotal RE-LY clinical trial of Pradaxa (dabigatran etexilate) for the prevention of stroke in non-valvular atrial fibrillation (NVAF), extensive clinical trial and real-world data support Pradaxa in various indications.

German family-owned pharma major Boehringer Ingelheim says it continues to grow the evidence base for Pradaxa to improve care for patients at risk of blood clots and today announces the initiation of Phase III of the GLORIA-AF registry program in North America and in Europe. During this final phase of the registry program, data on the overall safety and effectiveness of antithrombotic treatments will be collected.

"The body of evidence supporting Pradaxa, based on clinical trials, analyses of large real-world databases and different regulatory assessments since the RE-LY trial was first presented, is both robust and consistent," said Jorg Kreuzer, therapeutic area head cardiovascular medicine, Boehringer Ingelheim. "And we will continue our research both in clinical trials and in clinical practice to further strengthen this evidence base for Pradaxa to support the confident use of our treatment by physicians and patients, so that patients can receive the best possible care," Prof Kreuzer added.