- Recent analysis of real world data document again the positive safety and efficacy profile of Pradaxa® as proven in clinical trials1-3
- Final Phase of GLORIA™-AF Registry Program now initiated in North America and Europe
- Extensive clinical research in established and new indications underway to improve patient care with Pradaxa®
INGELHEIM, Germany I September 1, 2014 I 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),4 extensive clinical trial and real-world data support Pradaxa® in various indications.1-12 Boehringer Ingelheim 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.13
“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 Professor Jörg 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.”
The extensive research programme by Boehringer Ingelheim for Pradaxa®, aimed at deepening the science behind effective clot prevention and providing support for everyday patient management, will eventually include over 100,000 patients.4-19 The research programme covers both clinical studies and analyses of everyday clinical practice and includes the GLORIA™-AF registry, the recently announced RE-CIRCUIT™, RE-DUAL PCI™ and RE-SPECT ESUS™* studies for Pradaxa®†, and the RE-VERSE AD™ trial to investigate the antidote idarucizumab‡ in the clinical setting in patients taking Pradaxa®.4-19
Beyond the Boehringer Ingelheim research programme, independent studies have been conducted that support the efficacy and safety profile of Pradaxa®.1-3 The U.S. Food and Drug Administration recently reinforced the favourable efficacy and safety profile of Pradaxa® based upon a large analysis of Medicare data.§3 The analysis involved 134,000 patients, 65 years or older and its findings were consistent with results of the clinical RE-LY® trial that supported the global approval of Pradaxa® for stroke prevention in non-valvular atrial fibrillation.3-5 The study found that, among new users of blood-thinning drugs, Pradaxa® was associated with a similar risk of myocardial infarction (MI) compared to warfarin and an increased risk of major gastrointestinal (GI) bleeding, just like in RE-LY®.3-5 But most importantly, the study also showed that with Pradaxa®, there was a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin treatment.3
* Dabigatran etexilate is not approved in any country for patients with ESUS.
†The new trial announcements have not received indication approvals.
‡ Idarucizumab is the recommended International Nonproprietary Name (INN). The antidote is still under investigation and has not yet been approved for clinical use.
§ In the United States, the licensed doses for dabigatran etexilate are 150mg twice daily and 75mg twice daily for the prevention of stroke and systemic embolism in adult patients with non-valvular AF.20 The dose of 75mg twice daily is not authorised in Europe for this indication.21
