Boehringer Ingelheim Pharmaceuticals, Inc. today announced the launch of the GLORIA™-AF Registry Program, the largest prospective observational study in non-valvular atrial fibrillation (NVAF) planned at this time. With a goal of enrolling 56,000 patients, the registry aims to understand the long-term use of antithrombotic treatments to reduce the risk of stroke in patients with NVAF.
GLORIA-AF will follow newly-diagnosed NVAF patients who are at risk of stroke from 50 countries. The registry, which will be completed in 2020, is designed to gather real-world data on patient demographics, disease characteristics, treatment decisions, and the safety and efficacy of various antithrombotic therapies, including, but not limited to, warfarin, acetylsalicylic acid, Pradaxa® (dabigatran etexilate mesylate) 150mg capsules and Xarelto® (rivaroxaban).*
"With the launch of GLORIA-AF, Boehringer Ingelheim continues to broaden the understanding of non-valvular atrial fibrillation," said John Smith, MD PhD, senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The introduction of recently-approved oral anticoagulants changed the treatment landscape for many people living with this condition and BI is leading efforts through our registry to collect important real-world information with the goal of improving patient care."
Warfarin has long been the standard of care to reduce the risk of stroke in patients with NVAF. Recently, two oral anticoagulants have been approved to reduce the risk of stroke in this setting, with several others in late-stage clinical development.
GLORIA-AF will enroll patients from 2,200 sites across a range of clinical settings, including primary care practices, specialist offices, community hospitals, research institutions, outpatient care centers and anticoagulation clinics. To date, sites in the United States, Europe, Latin America and Asia have agreed to participate, providing the potential to identify meaningful information about regional or country-specific differences in patient demographics and treatment decisions.
Atrial fibrillation, characterized by an irregular heartbeat, can cause blood clots to form in the heart that can travel to the brain and cause a stroke. An estimated 2.3 million Americans are living with atrial fibrillation, and the prevalence is expected to increase to 5.6 million by 2050. Non-valvular atrial fibrillation, which accounts for up to 95 percent of diagnosed cases of atrial fibrillation,refers to cases of atrial fibrillation without rheumatic mitral valve disease, prosthetic heart valve or valve repair, according to the 2006 ACC/AHA/ESC guidelines. Atrial fibrillation increases the risk of stroke nearly five timesand is associated with up to 15 percent of all strokes in the U.S. Atrial fibrillation imposes a substantial economic burden to the healthcare system, specifically the high costs associated with stroke.
In the pivotal RE-LY® trial, PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism in patients with NVAF by 35 percent beyond the reduction achieved with warfarin dosed to target INR 2.0 to 3.0 (median TTR 67%).PRADAXA 150mg also was shown to significantly reduce both ischemic and hemorrhagic stroke compared to warfarin in patients with NVAF. Effects of PRADAXA compared to warfarin were more apparent in patients with lower levels of INR control.