Boehringer Ingelheim Korea said Wednesday it would present nine sub-analyses from the RE-DUAL PCI trial and the GLORIA-AF Registry Program, at the upcoming European Society of Cardiology (ESC) Congress 2018.
The ESC Congress, hosted by the European Society of Cardiology, will open in Munich, Germany, on Aug. 25 and continue through Aug. 29.
The primary data from the studies have led to a positive label update for its novel oral anticoagulant (NOAC) Pradaxa (dabigatran etexilate) in the European Union, according to Boehringer
The RE-DUAL PCI trial investigated anticoagulation in patients with non-valvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI) and stent placement.
Data showed a significantly lower rate of major or clinically relevant non-major bleeding events for dual therapy with Pradaxa when compared to triple treatment with warfarin. Efficacy also was similar, the company said.
Results from GLORIA-AF – an extensive, prospective, observational study program on nearly 5,000 AF patients treated with Pradaxa – showed the rates of stroke, major bleeding, and life-threatening bleeding were low.
The data was consistent with the long-term safety profile observed in other real-world evidence studies and randomized clinical trials, Boehringer said.
“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, corporate vice president and head of Cardiometabolic Medicine at Boehringer Ingelheim. “We are pleased to see that the EMA and the medical community also acknowledge the value these studies bring, reflected by the updates to the EU SmPC and the number of abstracts accepted for presentation at ESC Congress 2018.”
Details of the data presented at ESC Congress 2018 can be found online.
<© Korea Biomedical Review, All rights reserved.>