Presentations to include research around antidote for dabigatran, a post-hoc analysis of data from the RE-LY® trial and data from the GLORIA™-AF registry

RIDGEFIELD, Conn. -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that data from three company-sponsored PRADAXA studies will be presented at the American College of Cardiology 63rd Annual Scientific Session (ACC.14) in Washington, D.C., March 29 to 31, 2014.

An oral presentation will highlight pre-clinical data on the development of a specific antidote to reverse dabigatran in cases of bleeding. The investigational fully humanized antibody fragment, known as the Fab (idarucizumab*), was discovered and is being studied by Boehringer Ingelheim.

Post-hoc analysis of data from the pivotal RE-LY® trial, presented during a poster session, will describe the use of dabigatran compared to warfarin in patients with atrial fibrillation and valvular heart disease (VHD). PRADAXA is currently approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) based on RE-LY, one of the largest stroke prevention studies ever conducted in patients with NVAF. PRADAXA is not currently approved for patients with VHD.

Another poster presentation will provide data from the ongoing long-term GLORIA-AF registry, a worldwide prospective observational study – the largest of its kind – designed to identify factors influencing the selection of antithrombotic treatment to prevent stroke in patients with NVAF and to collect data on associated outcomes in clinical practice. The new data provide the first assessment of baseline characteristics of dabigatran and vitamin K antagonist (VKA) groups of patients in North America.

Further information regarding the data presentations includes:

Oral Presentation

• Sunday, March 30
   Session: Emerging and Procedural Issues in Arrhythmias
  • A Specific Antidote to Dabigatran Reduces Blood Loss in Dabigatran- and Trauma-induced Bleeding in a Pig Model (Lead Author: O. Grottke) [Abstract No. 921-03, 10:45-11:00 a.m., Room 145B]

Poster Presentations

• Saturday, March 29
   Session: Arrhythmias and Clinical EP: State of the Art Anticoagulation for Atrial Fibrillation
  • Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial (Lead Author: M. Ezekowitz) [Abstract No./Poster No: 1109-115, 10:00–10:45 a.m., Hall C]  
    
• Sunday, March 30
   Session: Arrhythmias and Clinical EP: New Observations Affecting Clinical Management
  • The Global Registry Program on Long-Term Oral Anti-thrombotic Treatment In Patients with Atrial Fibrillation (GLORIA-AF): First Assessment of Baseline Characteristics of Dabigatran and VKA Cohorts in North America (Lead Author: K. Rothman) [Abstract No./Poster No: 1217-104, 3:45-4:30 p.m., Hall C]

Additional information about PRADAXA will be available at the Boehringer Ingelheim Pharmaceuticals, Inc. booth #3227 at the ACC Scientific Session.

Source: Boehringer Ingelheim Pharmaceuticals, Inc.