| Results of RE-DUAL PCI™ and GLORIA™-AF have led to updates of the EU Summary of Product Characteristics (SmPC) for Pradaxa®
INGELHEIM, Germany -Monday 20 August 2018 [ AETOS Wire ]
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
(BUSINESS WIRE)-- Boehringer Ingelheim today announced that it will present nine sub-analyses from the RE-DUAL PCITM trial and GLORIATM-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 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 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:
Abstract Title
Details
(Venue: Messe München GmbH, Munich)
RE-DUAL PCITM
High body mass index and outcomes of dual antithrombotic therapy with dabigatran and a P2Y12 inhibitor in patients with atrial fibrillation undergoing PCI: Results from RE-DUAL PCITM
SPAF-A346 (1160.186)
15:50 – 16:40, 26 Aug 2018, Moderated Poster station- Poster Area
The effect of age on the efficacy and safety of dabigatran dual therapy in atrial fibrillation after PCI: a subgroup analysis from the RE-DUAL PCITM
SPAF-A360 (1160.186)
15:50 – 16:40, 26 Aug 2018, Moderated Poster station- Poster Area
The effect of PCI complexity on the efficacy and safety of dabigatran dual therapy vs warfarin triple therapy in atrial fibrillation: a subgroup analysis from the RE-DUAL PCITM trial
SPAF-A356 (1160.186)
10:05 - 10:55, 27 Aug 2018, Moderated Poster station- Poster Area
Dual antithrombotic therapy with dabigatran vs triple therapy with warfarin after PCI in patients with atrial fibrillation and diabetes mellitus (a RE-DUAL PCITM subgroup analysis)
SPAF-A358 (1160.186)
8:30 - 12:30, 28 Aug 2018, Best Posters screen - Poster Area
GLORIATM-AF
Two-year outcomes of dabigatran etexilate treatment in patients with co-morbid heart failure and atrial fibrillation: the GLORIATM-AF registry
SPAF-A343 (1160.129/136/171)
14:00 – 18:00, 26 Aug 2018, Posters- Poster Area
Two-year outcomes of dabigatran etexilate in patients with atrial fibrillation with and without a history of coronary artery disease: Data from GLORIATM-AF
SPAF-A354 (1160.129/136/171)
14:00 – 18:00, 26 Aug 2018, Posters- Poster Area
When are Atrial Fibrillation Patients at Risk to Discontinue Anticoagulation Treatment? Results from the GLORIATM-AF Registry
SPAF-A349 (1160.129/136/171)
14:00 – 18:00, 27 Aug 2018, Posters- Poster Area
A prospective global registry on oral antithrombotic treatment in patients with atrial fibrillation: GLORIATM-AF Phase III baseline characteristics; (1160.129/136/171)
SPAF-A347 (1160.129/136/171)
08:30 – 12:30, 27 Aug 2018, Posters- Poster Area
Geographic region, stroke risk and renal function strongly affect treatment choice for stroke prevention in patients with non-valvular AF: results from the GLORIATM-AF registry program
SPAF-A353 (1160.129/136/171)
10:05 – 10:55, 28 Aug 2018, Moderated Poster station- Poster Area
Others
Evaluation of VTE-BLEED for predicting intracranial or fatal bleedings in stable anticoagulated patients with venous thromboembolism
VTE-A72 (Study TBC)
12:35, 25 Aug 2018, Moderated Poster station- Poster Area
Safety and Effectiveness of Dabigatran Relative to Warfarin in Routine Care – Final results from a long-term monitoring program; (1160.207)
SPAF-A357 (1160.207)
12:35 - 13:25, 25 Aug 2018, Moderated Poster station - Poster Area
Trauma victims requiring dabigatran reversal with idarucizumab in RE-VERSE AD
SPAF-A356 (1160.186)
08:30 - 12:30, 27 Aug 2018, Posters- Poster Area
Making sense of real-world evidence: addressing the uncertainties surrounding anticoagulation for stroke prevention in non-valvular atrial fibrillation
MAPOR-A42
TBC
More information on the Boehringer Ingelheim data due to be presented or published at the ESC Congress 2018 can be found here.
Intended audiences:
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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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