GLORIA-AF Registry Studies Boehringer Ingelheim's Pradaxa in NVAF Patients in Routine Clinical Care

August 29, 2016—Boehringer Ingelheim Pharmaceuticals, Inc. announced that first outcome results from the GLORIA-AF registry show that treatment with the company’s Pradaxa (dabigatran etexilate mesylate) medication was associated with low incidences of stroke, major bleeding, and life-threatening bleeding. The results from approximately 3,000 patients with nonvalvular atrial fibrillation (NVAF) were presented in a late-breaking session at the European Society of Cardiology (ESC) Congress 2016 held August 27–31 in Rome, Italy. 

According to the company, these data from GLORIA-AF add to an 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.

As summarized by Boehringer Ingelheim, the data presented at ESC are from phase 2 of the GLORIA-AF registry and describe outcomes in 2,932 patients newly diagnosed with NVAF who were followed for 2 years. The findings show:

• Low incidence of safety outcomes for Pradaxa-treated patients in real-world clinical practice, with 1.12% of these patients experiencing a major bleed, and 0.54% experiencing a life-threatening bleed.
• Pradaxa effectively reduced the risk of stroke for NVAF patients, with only 0.63% of Pradaxa-treated patients experiencing a stroke.
• The safety and effectiveness of Pradaxa was maintained during 2 years of follow-up in routine clinical care.

Jonathan L. Halperin, MD, study investigator and member of the GLORIA-AF steering committee, commented in the company’s announcement, “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. These interim findings from GLORIA-AF are consistent with the results of the randomized RE-LY trial and previous population-based studies, including a US 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.” Dr. Halperin is the Robert and Harriet Heilbrunn Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York, New York.

The company advised that the GLORIA-AF registry examining antithrombotic use in routine clinical care around the world will enroll up to 56,000 NVAF patients. Results are 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.