ESC Congress 2016 Late Breaking Science Registry Latest data on dabigatran etexilate safety and effectiveness profile show low rates of bleeding and stroke in NVAF patients in routine clinical care

First outcome results from the GLORIA^™-AF Registry show that treatment with dabigatran etexilate was associated with low incidences of stroke, major bleeding and life-threatening bleeding. The results from approximately 3,000 patients with non-valvular atrial fibrillation (NVAF) were presented in a late breaking science registry session at the ESC Congress 2016 in Rome, Italy.¹ These data from GLORIA^™-AF add to the extensive body of data supporting the safety and effectiveness profile of dabigatran for stroke risk reduction and are consistent with data seen in recently published studies assessing anticoagulant use in everyday clinical practice.^3-19

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The data presented are from Phase II of the GLORIA^™-AF registry, and describe outcomes in 2,932 patients newly diagnosed with NVAF who were followed for two years.¹ The findings show:

• Low incidence of safety outcomes for dabigatran-treated patients in real-world clinical practice: only 1.12% of dabigatran-treated patients experienced a major bleed, and only 0.54% experienced a life-threatening bleed¹
• Dabigatran effectively reduced the risk of stroke for NVAF patients: less than 1% of dabigatran-treated patients experienced a stroke (0.63%)^1,20
• The safety and effectiveness of dabigatran was maintained over two years of follow up in routine clinical care¹

“Real-world studies such as the GLORIA^™-AF Registry complement knowledge gained from randomised controlled clinical trials and offer insights from larger, more diverse and co-morbid patient populations in varied medical settings,” said Professor Gregory Lip, Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, UK. “The findings from GLORIA^™-AF show once again that the favourable risk-benefit profile of dabigatran established in the pivotal Phase III RE-LY^® clinical trial is also observed in routine clinical care. This is consistent with findings from previous large real-world analyses including the US FDA Medicare analysis and the recently published results from Danish nationwide health databases, which were both independently conducted.”

GLORIA^™-AF is one of the largest ongoing registry programs examining antithrombotic use in routine clinical care around the world. Up to 56,000 NVAF patients will be enrolled, with results expected to support physician decision-making regarding the use of antithrombotics for stroke prevention. To date, more than 34,500 patients have been included in the GLORIA^™-AF Registry Program.^2,21

Boehringer Ingelheim conducts a number of other studies investigating the use of its products in routine clinical care in anticoagulation management: RE-COVERY DVT/PE™, a global observational study on the management of blood clots in the legs (deep vein thrombosis, DVT) and in the lungs (pulmonary embolism, PE).²² Another recently launched study is RE-VECTO, a global program to capture data on idarucizumab usage in clinical practice.²³ Idarucizumab is the first and only specific NOAC reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of dabigatran is required,^24,25 and is widely available and stocked in over 5,500 hospitals worldwide, including more than 2,500 hospitals in Europe.²¹

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. 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.

~ENDS~

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