News | Antiplatelet and Anticoagulation Therapies | September 01, 2016

Pradaxa Shows Low Bleeding, Stroke Rates in GLORIA-AF Registry

Safety, effectiveness maintained over two years of follow-up for non-valvular atrial fibrillation patients in initial Phase II results

Pradaxa, dabigatran, GLORIA-AF registry, ESC Congress 2016, NVAF

September 1, 2016 — 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 percent of Pradaxa-treated patients experienced a major bleed, and only 0.54 percent experienced a life-threatening bleed;
  • Pradaxa effectively reduced the risk of stroke for NVAF patients: less than 1 percent of Pradaxa-treated patients experienced a stroke (0.63 percent); and
  • Safety and effectiveness 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.

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