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.

For more information: www.boehringer-ingelheim.com

Related Content

Experimental Vaccine May Reduce Post-Stroke Blood Clot Risk
News | Antiplatelet and Anticoagulation Therapies | November 01, 2018
A vaccine may one day be able to replace oral blood thinners to reduce the risk of secondary strokes caused by blood...
Thrombolytic Science Initiates Phase 2 Trial of Novel Ischemic Stroke Treatment Regimen
News | Antiplatelet and Anticoagulation Therapies | September 07, 2018
A new Phase 2 clinical trial looks to confirm the efficacy and safety of Thrombolytic Science LLC’s (TSI) sequential...
Bleeds and Benefit With Aspirin Balanced in Diabetes Patients
News | Antiplatelet and Anticoagulation Therapies | September 05, 2018
Aspirin prevented serious vascular events in patients with diabetes who did not already have cardiovascular disease,...
Extended Post-Hospital Oral Anticoagulant Use Reduces Non-Fatal Blood Clots
News | Antiplatelet and Anticoagulation Therapies | August 31, 2018
Use of an oral anticoagulant in medically ill patients for 45 days following hospital discharge reduces the rate of non...
AFib Patients Want More Information About Anticoagulation Reversal
News | Antiplatelet and Anticoagulation Therapies | June 27, 2018
Results from a 902-person, five-country survey of people living with atrial fibrillation (AF) reinforce the importance...
Lower Oral DOAC Anticoagulant Use Associated With More Thromboembolic Events Than Warfarin. #HRS 2018
News | Antiplatelet and Anticoagulation Therapies | May 18, 2018
May 18, 2018 — Nearly half of patients prescribed warfarin and just under one third of those using newer direct oral
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

 

Feature | Antiplatelet and Anticoagulation Therapies | May 07, 2018
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated...
The largest trial to date for short-term DAPT concluded the practice cannot be deemed safe due to a higher adverse event rate. Image courtesy of the American Heart Association. #ACC18

The largest trial to date for short-term DAPT concluded the practice cannot be deemed safe due to a higher adverse event rate. Image courtesy of the American Heart Association.

News | Antiplatelet and Anticoagulation Therapies | March 19, 2018
The combined rate of death from any cause, heart attack or stroke within 18 months was not significantly different in...
The Xarelto booth at ACC.18

The Xarelto booth at the 2018 American College of Cardiology meeting. 

News | Antiplatelet and Anticoagulation Therapies | March 14, 2018
March 14, 2018 — A late-breaking analysis of the landmark COMPASS study presented at the American College of Cardiolo
Overlay Init