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Boehringer Ingelheim to Present Interim Safety and Efficacy Data for Pradaxa® (dabigatran etexilate mesylate) in Longer-Term Use at the AHA’s Scientific Sessions

October 30, 2012

RIDGEFIELD, Conn., Oct. 30, 2012 /PRNewswire/ — Boehringer Ingelheim will present data from 16 abstracts at the American Heart Association’s (AHA) Scientific Sessions in Los Angeles from November 3 to 7, 2012, including data on Pradaxa(®) (dabigatran etexilate mesylate) capsules and data evaluating patients with non-valvular atrial fibrillation (NVAF). These data reinforce BI’s commitment to adding to the scientific body of evidence for PRADAXA and stroke prevention in NVAF.

Highlighted at the AHA meeting will be interim results from RELY-ABLE(®), a long-term extension trial of the pivotal RE-LY(®) study, which will be featured in the Clinical Science: Special Reports presentations on November 7.

In addition, a RE-LY sub-analysis that examined “ischemic stroke equivalents,” a method used to integrate ischemic and bleeding events, that compared a weighted benefit of two doses of dabigatran with each other and warfarin, will be presented on November 5. A different RE-LY sub-analysis that examined patient characteristics and outcomes in patients with NVAF who had diabetes compared to those without diabetes will be presented on November 4.

Detailed information regarding the data presentations include:

  • Sunday, November 4, General Poster Sessions

    • The Influence on Plaque Formation and Endothelial Function in Apoe-Deficient Mice by Direct Thrombin Inhibition with Dabigatran (Lead Author: M.T. Kratz) [Abstract No. 14060, 9:30 a.m. - 11:00 a.m.]
    • Comparison of Dabigatran versus Warfarin in Diabetic Patients with Atrial Fibrillation: Results from the RE-LY Trial (Lead Author: H. Darius) [Abstract No. 15937, 3:00 p.m. - 4:30 p.m.]
  • Monday, November 5, Oral Sessions

    • Cluster Randomized Controlled Trial to Test The Effect of a Multifaceted Comprehensive Cardiovascular Care Intervention on Clinical Outcomes in Atrial Fibrillation Patients Receiving Dabigatran (Lead Author: R. Nieuwlaat) [Abstract No. 12618, 9:00 a.m. - 9:15 a.m.]
    • Reversal of Anticoagulant Activity of Dabigatran and Dabigatran-induced Bleeding in Rats by a Specific Antidote (Antibody Fragment) (Lead Author: J. van Ryn) [Abstract No. 9928, 9:15 a.m. - 9:30 a.m.]
    • Dabigatran Versus Warfarin in Very Elderly Patients with Atrial Fibrillation: Results from the RE-LY Trial (Lead Author: M. Coppens) [Abstract No. 15537, 9:30 a.m. - 9:45 a.m.]
    • Balancing the Benefits and Risks of Two Doses of Dabigatran Compared with Warfarin in Atrial Fibrillation (Lead Author: J. Eikelboom) [Abstract No. 14433,11:30 a.m. - 11:45 a.m.]
    • Successful Reversal of Dabigatran-Induced Bleeding by 3-Factor Coagulation Concentrates in a Rat Tail Bleeding Model: Lack of Correlation with ex vivo Markers of Anticoagulation (Lead Author: J. van Ryn) [Abstract No. 11955, 11:30 a.m. - 11:45 a.m.]
  • Monday, November 5, General Poster Sessions

    • Safety and Efficacy of Once Daily 220 mg Dabigatran Etexilate in a Real-World NonInterventional Study of More Than 5000 Patients After Total Knee or Hip Replacement (Lead Author: N. Rosencher) [Abstract No. 10001, 3:00 p.m. - 4:30 p.m.]
  • Tuesday, November 6, Oral Sessions

    • Importance of Persistent Elevation of Cardiac Biomarkers in Atrial Fibrillation – A RE-LY Substudy (Lead Author: Z. Hijazi) [Abstract No. 14808, 4:45 p.m. - 5:00 p.m.]
  • Tuesday, November 6, General Poster Sessions

    • Anemia is Associated with an Adverse Outcome in Patients with Atrial Fibrillation: Insights From the RE-LY Trial (Lead Author: B.D. Westenbrink) [Abstract No. 18466, 9:30 a.m. - 11:00 a.m.]
    • Regional Variation in Ischemic Stroke Rates and Oral Anticoagulant Use Among the Non-Valvular Atrial Fibrillation Medicare Population (Lead Author: K. Fitch) [Abstract No. 12992, 9:30 a.m. - 11:00 a.m.]
    • Association between Outpatient Visits Following Hospital Discharge and Readmissions among Medicare Beneficiaries with Atrial Fibrillation (Lead Author: M. Hubbard) [Abstract No. 11367, 9:30 a.m. - 11:00 a.m.]
    • Incidence of Bleeding Events in Patients with Atrial Fibrillation (Lead Author: T. Murray-Thomas) [Abstract No. 14178, 3:00 p.m. - 4:30 p.m.]
  • Wednesday, November 7, Clinical Science: Special Reports

    • Randomized Comparison of the Effects of Two Doses of Dabigatran Etexilate on Clinical Outcomes Over 4.3 Years: Results of the RELY-ABLE Double-blind Randomized Trial (Lead Author: S. Connolly) [Location: Petree Hall D, 11:55 a.m. - 12:05 p.m.]
  • Wednesday, November 7, General Poster Sessions

    • Cost-Effectiveness of Dabigatran Etexilate versus Rivaroxaban for Stroke and Systemic Embolism Risk Reduction in Atrial Fibrillation: A US Third Party Payer Perspective (Lead Author: D. Walker) [Abstract No. 14964, 9:30 a.m. - 11:00 a.m.]
    • Registry to Evaluate Anticoagulation with Warfarin in Atrial Fibrillation (REAL-AF) (Lead Author: D. Garcia) [Abstract No. 16451, 9:30 a.m. - 11:00 a.m.]

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

CONTRAINDICATIONS
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 & 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.

ADVERSE REACTIONS
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
In the pivotal trial, a higher rate of clinical myocardial infarction was reported in patients who received PRADAXA (0.7 per 100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

For full PRADAXA prescribing information, please visit www.pradaxa.com or contact Boehringer Ingelheim’s Medical and Technical Information Unit at 1-800-542-6257.

About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs
For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.

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.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

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.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

PRADAXA(®) is a registered trademark of Boehringer Ingelheim Pharma GmBH and Co. KG and used under license.

RE-LY(®) and RELY-ABLE(®) are registered service marks of Boehringer Ingelheim International GmBH and used under license.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.


Source: PR Newswire