Boehringer Ingelheim GmbH
- INGELHEIM, Germany|제약
Results of RE-DUAL PCI™ and GLORIA™-AF have led to updates of the EU Summary of Product Characteristics (SmPC) for Pradaxa®
Nine sub-analyses from RE-DUAL PCI™ and GLORIA™-AF accepted for presentation at ESC Congress 2018
Data from both studies have led to positive update of the SmPC for Pradaxa® in the EU
INGELHEIM, GERMANY--(Business Wire / Korea Newswire) August 20, 2018 -- Boehringer Ingelheim today announced that it will present nine sub-analyses from the RE-DUAL PCI™ trial and GLORIA™-AF Registry Program at the upcoming ESC Congress 2018, organised by the European Society of Cardiology, taking place in Munich, Germany on the 25-29 August 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 PCI™ 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]
GLORIA™-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. These data are consistent with the long-term safety profile observed in other real-world evidence studies, as well as in randomised clinical trials.
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.
“Insights from the RE-DUAL PCI™ and GLORIA™-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 Boehringer Ingelheim. “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.”
Details of the data presented at ESC Congress 2018 are as follows:
(To view the details of the data, please visit http://bit.ly/2MnInuV)
More information on the Boehringer Ingelheim data due to be presented or published at the ESC Congress 2018 can be found here (http://bit.ly/2MmHZNi).
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. It is directed to the international audience outside Germany. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
For references and notes to editors, please visit: https://www.boehringer-ingelheim.com/press-release/new-data-at-ESC-supports-Pradaxa-safety-profile
View source version on businesswire.com: https://www.businesswire.com/news/home/20180820005042/en/
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