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% of PRADAXA-treated patients experienced a major bleed, and only 0.54% experienced a life-threatening bleed
- PRADAXA effectively reduced the risk of stroke for NVAF patients: less than 1% of PRADAXA-treated patients experienced a stroke (0.63%)
- The safety and effectiveness of PRADAXA was maintained over two years of follow up in routine clinical care
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.
Boehringer Ingelheim conducts a number of other studies investigating the use of its products in routine clinical care in anticoagulation management: RE-COVERY DVT/PE™, a global observational study on the management of blood clots in the legs (deep vein thrombosis, DVT) and in the lungs (pulmonary embolism, PE). Another recently launched study is RE-VECTO, a global program to capture data on Praxbind® (idarucizumab) usage in clinical practice. PRAXBIND is a specific reversal agent approved for use in emergency situations when reversal of the anticoagulant effect of PRADAXA is required, and is available and stocked in over 5,500 hospitals worldwide, including more than 2,760 hospital pharmacies in the U.S.
About the GLORIA-AF Registry ProgramGLORIA-AF is a global Registry Program run in different phases and designed to characterize the population of newly diagnosed patients with NVAF at risk for stroke, and to study patterns, predictors and outcomes of different treatment regimens for stroke prevention. Patient characteristics, clinical usage patterns and patient outcomes of anticoagulation therapy will be documented in up to 56,000 patients in 2,200 sites and more than 50 countries throughout the world.
About Pradaxa® (dabigatran etexilate mesylate)
Indications and UsagePradaxa® (dabigatran etexilate mesylate) capsules is indicated:
- to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation
- use of indwelling epidural catheters
- concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
- a history of traumatic or repeated epidural or spinal punctures
- a history of spinal deformity or spinal surgery
- optimal timing between the administration of PRADAXA and neuraxial procedures is not known
CONTRAINDICATIONSPRADAXA is contraindicated in patients with:- active pathological bleeding;- known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA; - mechanical prosthetic heart valve
WARNINGS & PRECAUTIONSIncreased Risk of Thrombotic Events after Premature DiscontinuationPremature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA as soon as medically appropriate.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 (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA in patients with active pathological bleeding.
- Risk factors for bleeding include concomitant use of 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.
- Reversal of Anticoagulant Effect: A specific reversal agent (idarucizumab) for dabigatran is available when reversal of the anticoagulant effect of dabigatran is needed:
- For emergency surgery/urgent procedures
- In life-threatening or uncontrolled bleeding
Thromboembolic and Bleeding Events in Patients with Prosthetic Heart ValvesThe use of PRADAXA is contraindicated in patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.Effect of P-gp Inducers & Inhibitors on Dabigatran ExposureConcomitant 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.Reduction of Risk of Stroke/Systemic Embolism in NVAF
- For patients with moderate renal impairment (CrCl 30-50 mL/min), reduce 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.
- Most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding & gastrointestinal (GI) events.
- PRADAXA 150 mg resulted in higher rates of major and any GI bleeds compared to warfarin.
- In patients ?75 years of age, the risk of major bleeding may be greater with PRADAXA vs 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)
Please see full Prescribing Information, including boxed WARNING and Medication Guide.
About Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.
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Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, GLORIA™-AF, RE-LY®, RE-COVERY DVT/PE™ and Praxbind® under license.
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.