New efficacy and safety data for dabigatran to be announced at American Heart Association’s Scientific Sessions 2013


Boehringer Ingelheim has announced the upcoming presentation of the latest efficacy and safety data for the novel oral anticoagulant dabigatran etexilate (Pradaxa) at the 2013 American Heart Association’s (AHA) Scientific Sessions (16–20 November, Dallas, USA).

The company announced that data from eight presentations sponsored by Boehringer Ingelheim are included in the scientific programme.

Presentations will include the first results from a healthy volunteer study of a dabigatran-specific antidote as an additional option for physicians in emergency situations where the reversal of the anticoagulation effect of dabigatran is required. In addition, unique outcome data from over six years of follow-up data from the pivotal phase III RE-LY trial and its extension study RELY-ABLE will be announced, as well as real-world data from routine care on dabigatran compared to warfarin in patients with non-valvular atrial fibrillation.

In addition, the company announced, previously presented clinical research on dabigatran from the RE-LY trial, one of the largest clinical studies ever conducted in stroke prevention in patients with non-valvular atrial fibrillation, will be recognised and awarded during the congress, highlighting the scientific value the work around this trial continues to provide to the medical community. An article by Stefan Hohnloser, University Hospital, Frankfurt, Germany, which was originally published in 2012, has been chosen by the Circulation editors to receive the ‘Best Paper Award: Clinical Science’. The article analysed data on myocardial ischaemic events reported in the RE-LY trial and concluded that for the broader composite endpoint of relevant cardiovascular ischaemic events, the incidence was numerically lower with dabigatran than with warfarin. A scientific presentation by Jean-Yves Le Heuzey, European Georges Pompidou Hospital, Paris, France, first shown at the International Stroke Conference 2013, will be featured in the ‘Best of AHA Specialty Conferences’.