BOEHRINGERINGELHEIM today, Monday, August 20, announced that it will present nine sub-analysis from the RE-DUAL PCITMtrialand GLORIATM-AF Registry Programme at the upcoming ESC Congress 2018, organised by the European Society of Cardiology, taking place in Munich, Germany on August 25-29, 2018. The primary data from these studies have contributed to a positive label update for dabigatran etexilate (Pradaxa®) in the European Union, EU.

The primary RE-DUAL PCITM trial investigated anticoagulation in patients with non-valvular atrial fibrillation (AF) following percutaneous coronary intervention, PCI, and stent placement. Data showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran etexilate when compared to triple therapy with warfarin without compromise on efficacy.1,2

GLORIATM-AF is a large, prospective, observational study program run in over 40 countries worldwide. The primary analysis of nearly 5000 AF patients treated with dabigatran etexilate showed that the rates of stroke, major bleeding and life-threatening bleeding were low, confirming the sustained safety and effectiveness of dabigatran etexilate over two years of follow-up in clinical practice.3 These data are consistent with the long-term safety profile observed in other real-world evidence studies, as well as in randomised clinical trials.3

Both studies have helped to further confirm the safety profile of dabigatran etexilate in high risk patient populations, as well as in a real-world setting. In recognition of this, the European Medicines Agency, EMA, has recently authorised the inclusion of data from both studies within the SmPC for dabigatran etexilate in the EU.4

“Insights from the RE-DUAL PCITM and GLORIATM-AF study data have helped to further inform the positive safety profile of dabigatran etexilate for the treatment of AF patients”, said Waheed Jamal, MD, Corporate Vice President & Head of Cardiometabolic Medicine at BoehringerIngelheim. “We are pleased to see that the value these studies bring is also acknowledged by the EMA and the medical community. This is reflected by the updates to the EU SmPC and the number of abstracts accepted for presentation at ESC Congress 2018.”

– Aug. 20, 2018 @ 15:39 GMT |