Boehringer Ingelheim Announces Launch of GLORIA™-AF Registry in Newly-Diagnosed Patients with Non-Valvular Atrial Fibrillation Worldwide 56,000-patient registry to assess safety and outcomes associated with antithrombotic treatments
RIDGEFIELD, Conn., May 3, 2012 /PRNewswire/ -- 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, M.D., Ph.D., 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 times and 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.
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About Pradaxa® (dabigatran etexilate mesylate) Capsules
Indications and Usage
PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.
WARNINGS AND PRECAUTIONS
Risk of Bleeding:
- PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.
- Risk factors for bleeding include medications that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). PRADAXA's anticoagulant activity and half-life are increased in patients with renal impairment.
- A specific reversal agent for dabigatran is not available. Dabigatran can be dialyzed (removal of about 60% of drug over 2-3 hours) but data supporting this is limited. Activated prothrombin complex concentrates, recombinant Factor VIIa, or concentrates of factors II, IX or X may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.
Temporary Discontinuation of PRADAXA
Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke. Minimize lapses in therapy.
Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.
- For patients with moderate renal impairment (CrCl 30-50 mL/min), consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
- For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and P-gp inhibitors.
In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin. In patients ≥75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer). Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.
OTHER MEASURES EVALUATED
The risk of myocardial infarction was numerically greater in patients who received PRADAXA 150 mg than in those who received warfarin.
For full PRADAXA prescribing information, please visit www.pradaxa.com or contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.
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About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
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In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
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