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Press Release

ESC Congress 2016 Late Breaking Science Registry: Latest Data on Pradaxa® (dabigatran etexilate mesylate) Safety and Effectiveness Profile Show Low Rates of Bleeding and Stroke in NVAF Patients in Routine Clinical Care

Boehringer Ingelheim
Posted on: 29 Aug 16

RIDGEFIELD, Conn., Aug. 29, 2016 /PRNewswire/ -- First outcome results from the GLORIA™-AF Registry show that treatment with Pradaxa® (dabigatran etexilate mesylate) 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 session at the ESC Congress 2016 in Rome, Italy. These data from GLORIA-AF add to the extensive body of data supporting the safety and effectiveness profile of PRADAXA for stroke risk reduction and are consistent with data seen in recently published studies assessing anticoagulant use in everyday clinical practice.

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. The findings show:

Low incidence of safety outcomes for PRADAXA-treated patients in real-world clinical practice: only 1.12% of PRADAXA-treated patients experienced a major bleed, and only 0.54% experienced a life-threatening bleed

PRADAXA effectively reduced the risk of stroke for NVAF patients: less than 1% of PRADAXA-treated patients experienced a stroke (0.63%)

The safety and effectiveness of PRADAXA was maintained over two years of follow up in routine clinical care

"Practice-based studies such as the GLORIA-AF Registry complement clinical trials by including larger, more diverse patient populations with the comorbidities encountered in various medical settings," said Jonathan L. Halperin, M.D., the Robert and Harriet Heilbrunn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, study author and member of the GLORIA-AF steering committee. "These interim findings from GLORIA-AF are consistent with the results of the randomized RE-LY® trial and previous population-based studies, including a U.S. Food and Drug Administration analysis of more than 134,000 Medicare recipients. Taken together, these data reinforce the favorable risk-benefit profile of dabigatran in routine care of patients with atrial fibrillation."

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.

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). Another recently launched study is RE-VECTO, a global program to capture data on Praxbind® (idarucizumab) usage in clinical practice. PRAXBIND is a specific reversal agent approved for use in emergency situations when reversal of the anticoagulant effect of PRADAXA is required, and is available and stocked in over 5,500 hospitals worldwide, including more than 2,760 hospital pharmacies in the U.S. 

About the GLORIA-AF Registry Program
GLORIA-AF is a global Registry Program run in different phases and designed to characterize the population of newly diagnosed patients with NVAF at risk for stroke, and to study patterns, predictors and outcomes of different treatment regimens for stroke prevention. Patient characteristics, clinical usage patterns and patient outcomes of anticoagulation therapy will be documented in up to 56,000 patients in 2,200 sites and more than 50 countries throughout the world.

Editor's Details

Mike Wood

Last updated on: 29/08/2016

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