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New Analyses of Data From RE-LY Trial, Involving Oral Anticoagulant Pradaxa, to be Presented at American Heart Association's Scientific Sessions

RIDGEFIELD, Conn., Nov. 11, 2010 /PRNewswire/ -- Results of two pre-specified sub-study analyses of the 18,113 patient RE-LY® trial,(1) involving the newly approved oral anticoagulant Pradaxa® (dabigatran etexilate mesylate) capsules,(2) will be presented at the American Heart Association's Annual Scientific Sessions on Monday, November 15, 2010.  The analyses assessed the prognostic value of two separate biomarkers (D-dimer and NT-proBNP) for predicting cardiovascular events in patients with non-valvular atrial fibrillation (AFib).(3,4)

RE-LY® was a global, Phase III, randomized trial, which investigated whether PRADAXA was as effective as well-controlled warfarin (open label) for stroke prevention in patients with non-valvular atrial fibrillation.(1) The study provided the basis for the U.S. Food and Drug Administration's (FDA) recent approval of PRADAXA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.(2)

Well-controlled warfarin, defined as INR 2.0 – 3.0, has been shown to reduce the risk of stroke in patients with non-valvular atrial fibrillation.(5)  Results of the RE-LY® trial demonstrated PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin.(2) PRADAXA 150mg taken twice daily also significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.(2)

PRADAXA is the only approved oral anticoagulant that has been shown to significantly reduce the risk of stroke compared to warfarin(2) and is the first oral anticoagulant to be approved in the U.S. in more than 50 years.  PRADAXA is now available in more than 35,000 pharmacies nationwide.  

About RE-LY®

RE-LY® was a global, Phase III, randomized trial(1) of 18,113 patients(1) enrolled in 951 centers in 44 countries,(6) investigating whether PRADAXA (two blinded doses) was as effective as well-controlled warfarin – INR 2.0 - 3.0 – (open label) for stroke prevention.(1) Patients with non-valvular AFib and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age greater than or equal to 75 years, age greater than or equal to 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension)(6) were enrolled in the study for two years with a minimum follow-up period of one year.(1)

The RE-LY® trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol,(1) which has been used in the previous trials of anticoagulation for stroke prevention in patients with AFib.(1)  A PROBE design may reflect the differences in the management of warfarin and PRADAXA in clinical practice.(1)

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(1) Safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction and other adverse events.(1)

In the RE-LY® trial, all clinical outcomes were adjudicated in a blinded manner to minimize bias in assessment of outcomes for each treatment.(1)

About Atrial Fibrillation and Stroke

Atrial fibrillation, characterized by an irregular heartbeat,(7) can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(7)  An estimated 2.3 million Americans are living with AFib,(8) and the prevalence is expected to increase to 5.6 million by 2050.(8) A large managed care database study showed that non-valvular atrial fibrillation represents approximately 95 percent of all atrial fibrillation cases in the U.S.(8)  Atrial fibrillation increases the risk of stroke nearly five times(9) and is associated with up to 15 percent of all strokes in the U.S.(9) Strokes associated with AFib can be about twice as likely to be fatal(10) or severely disabling as non-AFib strokes.(11) Atrial fibrillation imposes a substantial economic burden to the healthcare system,(12) specifically the high costs associated with stroke.(13)

About Pradaxa® (dabigatran etexilate) Capsules

Indications and Usage

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.



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.


Risk of Bleeding

PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Risk factors for bleeding include:

- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).

- Labor and delivery

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.

Temporary Discontinuation of PRADAXA

Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke.  Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.

Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure

The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other 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 events. PRADAXA 150 mg resulted in a higher rate of major gastrointestinal (GI) bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 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, 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 or contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.

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 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

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(1) Ezekowitz MD, et al. "Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulation therapy, warfarin, compared with dabigatran." American Heart Journal.  2009; 157: 805-810.

(2) Pradaxa Prescribing Information

(3) Eikelbloom J, et al. "D-dimer is Prognostic for Stroke, Major Bleeding and Death During Anticoagulation of Atrial Fibrillation - a RELY Substudy ", Presented at AHA 2010

(4) Hijazi Z, et al. "NT-proBNP is Prognostic for Stroke and Death in Atrial Fibrillation - a RELY Substudy", Presented at AHA 2010

(5) Hart, et al. "Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation." Annals of Internal Medicine. 146(2007); 857-867.

(6) Connolly SJ, et al. "Dabigatran versus Warfarin in Patients with Atrial Fibrillation." New England Journal of Medicine. 2009; 361:1139-1151.

(7) NHLBI website. "What is AFib?" Available at: Accessed on: August 2, 2010.

(8) Go, Alan S., and Elaine M. Hylek et al. Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the ATRIA Study. JAMA . 285(2001): 2370-2375.

(9) Wolf P, et al. Atrial Fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991; 22:983-988.

(10) Lin HJ, et al. "Stroke Prevention in Atrial Fibrillation: The Framingham Study." Stroke. 1996; 27:1760-1764.

(11)  Dulli D, et al. "Atrial Fibrillation is Associated with Severe Ischemic Stroke." Neuroepidemiology. 2003; 22:118-123.

(12) Coyne, K.S., et al. "Assessing the Direct Costs of Treating Nonvalvular Atrial Fibrillation in the United States." Value in Health.  2006; 9:348-356.

(13) Harley C., et al. Direct Costs And Health Care Utilization Associated With Stroke in the Presence of Atrial Fibrillation in the United States. ASAIS Conference, Feb. 2009.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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