New Safety and Efficacy Data for Pradaxa to be Presented at American Heart Associatio?n Scientific Sessions

Boehringer Ingelheim Pharmaceuticals, Inc. has announced that data from eight company-sponsored PRADAXA studies will be presented at the American Heart Association's (AHA) Scientific Sessions in Dallas, 16–20 November 2013.

The presentations — a mix of new clinical, epidemiological and pre-clinical data — will include long-term (median 4.6 years, maximum 6.7 years) follow-up data from the pivotal Phase III RE-LY trial and its extension study, RELY-ABLE; real-world safety data on PRADAXA compared with warfarin; and early clinical data on a specific antidote for dabigatran.

In addition, a journal article published in Circulation in 2012 will receive a "Best Paper" award during a special session. The article reported data on myocardial ischemic events seen in RE-LY, one of the largest stroke prevention clinical studies ever conducted in non-valvular atrial fibrillation (NVAF) patients. Further, a mortality analysis from RE-LY will be presented during the "Best of AHA Specialty Conferences".

Detailed information regarding the data presentations includes

Special Conferences and Presentations 

     •  Sunday Morning Programme, 17 November, Groundbreaking Studies in the Practice of Cardiovascular Medicine: Circulation Editors' Choices
         –  Best Paper Award: Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial (Best Paper Award Recipient: S. Hohnloser) [8–11 am]

     •  Monday, 18 November, Best of AHA
         – Stroke-Related Specific Mortality and Influencing Factors in Patients with Atrial Fibrillation in the RE-LY Trial (Lead Author: J. Le Heuzey) [Abstract No./Poster No. 9191/ISC39, 9:30–11 am]

Oral Presentations

     •  Monday, 18 November 
         –  A Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Healthy Male Volunteers (Lead Author: S. Glund) [Abstract No. 17765, 9:30–9:45 am]
         – RE-LY and RELY-ABLE: Long-term Follow-up of Patients with Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for up to 6.7 Years (Lead Author: M.D. Ezekowitz) [Abstract No. 10684, 11:45 am–noon]

     •  Wednesday, 20 November
         –  Monitoring the Safety and Effectiveness of Dabigatran and Warfarin in Routine Care: An Interim Analysis Using US Healthcare Utilization Data (Lead Author: J.D. Seeger) [Abstract No. 15187, 11–11:15 am]

Poster Presentations

     •  Sunday, 17 November
         –  Resuscitation With Different Infusion Solutions does not Influence Binding of Dabigatran to its Specific Antidote in a Pig Model of Hemorrhagic Shock. (Lead Author: O. Grottke) [Abstract No. 356, 7-8–30 am] (Note: this is part of the Best Original Resuscitation Science Poster Session).
         – Efficacy and Safety of Dabigatran Compared with Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation — a RE-LY Trial Analysis (Lead Author: Z. Hijazi) [Abstract No./Poster No. 13190/4026, 3–4:30 pm]

     •  Tuesday, 19 November
         – Benefits of Dabigatran versus Warfarin in Hypertensive Patients with Atrial Fibrillation: Results From The Re-ly Trial (Lead Author: R. Nagarakanti) [Abstract No./Poster No. 11087/4072, 3–4:30 pm]