New Safety and Efficacy Data for Pradaxa® (dabigatran etexilate mesylate) to be Presented at American Heart Association Scientific Sessions

RIDGEFIELD, Conn., Nov. 12, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced that data from eight company-sponsored PRADAXA studies will be presented at the American Heart Association's (AHA) Scientific Sessions in Dallas, November 16 to 20, 2013.

The presentations – a mix of new clinical, epidemiological and pre-clinical data – will include long-term (median 4.6 years, maximum 6.7 years) follow-up data from the pivotal Phase III RE-LY® trial and its extension study, RELY-ABLE®; real-world safety data on PRADAXA compared to warfarin; and early clinical data on a specific antidote for dabigatran. In addition, a journal article published in Circulation in 2012 will receive a "Best Paper" award during a special session. The article reported data on myocardial ischemic events seen in RE-LY, one of the largest stroke prevention clinical studies ever conducted in non-valvular atrial fibrillation (NVAF) patients. Further, a mortality analysis from RE-LY will be presented during the "Best of AHA Specialty Conferences."

Detailed information regarding the data presentations includes:

Special Conferences and Presentations

  • Sunday Morning Program, November 17, Groundbreaking Studies in the Practice of Cardiovascular Medicine: Circulation Editors' Choices
    • Best Paper Award: Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial (Best Paper Award Recipient: S. Hohnloser) [8–11 a.m.]
  • Monday, November 18, Best of AHA
    • Stroke-Related Specific Mortality and Influencing Factors in Patients with Atrial Fibrillation in the RE-LY Trial (Lead Author: J. Le Heuzey) [Abstract No. / Poster No. 9191 / ISC39, 9:30–11 a.m.]

Oral Presentations

  • Monday, November 18
    • A Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Healthy Male Volunteers (Lead Author: S. Glund) [Abstract No. 17765, 9:30–9:45 a.m.]
    • RE-LY and RELY-ABLE: Long-term Follow-up of Patients With Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for Up to 6.7 Years (Lead Author: M.D. Ezekowitz) [Abstract No. 10684, 11:45 a.m.–noon]
  • Wednesday, November 20
    • Monitoring the Safety and Effectiveness of Dabigatran and Warfarin in Routine Care: An Interim Analysis Using U.S. Healthcare Utilization Data (Lead Author: J.D. Seeger) [Abstract No. 15187, 11–11:15 a.m.]

Poster Presentations

  • Sunday, November 17
    • Resuscitation With Different Infusion Solutions does not Influence Binding of Dabigatran to its Specific Antidote in a Pig Model of Hemorrhagic Shock. (Lead Author: O. Grottke) [Abstract No. 356, 7–8:30 a.m.] (Note: this is part of the Best Original Resuscitation Science Poster Session).
    • Efficacy and Safety of Dabigatran Compared With Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation – a RE-LY Trial Analysis (Lead Author: Z. Hijazi) [Abstract No. / Poster No. 13190 / 4026, 3–4:30 p.m.]
  • Tuesday, November 19
    • Benefits of Dabigatran versus Warfarin in Hypertensive Patients With Atrial Fibrillation: Results From The Re-ly Trial (Lead Author: R. Nagarakanti) [Abstract No. / Poster No. 11087 / 4072, 3–4:30 p.m.]

Information about presentations related to dabigatran at AHA can be found here by selecting "advanced search" and entering "dabigatran" in the "Keyword/Title/Text" field.

About Pradaxa® (dabigatran etexilate mesylate) Capsules

Indications and Usage
Pradaxa® (dabigatran etexilate mesylate) capsules is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

WARNING: DISCONTINUING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE. Discontinuing PRADAXA places patients at an increased risk of thrombotic events. If anticoagulation with PRADAXA must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

CONTRAINDICATIONS
PRADAXA 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 & PRECAUTIONS
Increased Risk of Stroke with Discontinuation of PRADAXA
Discontinuing PRADAXA in absence of adequate alternative anticoagulation increases the risk of thrombotic events.  If PRADAXA must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

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.
  • A specific reversal agent for dabigatran is not available. Hemodialysis can remove dabigatran; however clinical experience for hemodialysis as a treatment for bleeding 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.

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
The safety and efficacy of PRADAXA in patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than 3 months prior to enrollment) was evaluated in the phase 2 RE-ALIGN trial.  RE-ALIGN was terminated early because of significantly more thromboembolic events (valve thrombosis, stroke, transient ischemic attack, and myocardial infarction) and an excess of major bleeding (predominantly post-operative pericardial effusions requiring intervention for hemodynamic compromise) for PRADAXA vs warfarin.  Therefore, the use of PRADAXA is contraindicated in patients with mechanical prosthetic valves.

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 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 higher rates 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).

Please see full Prescribing Information including Boxed WARNING, and Medication Guide

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 140 affiliates and more than 46,000 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 has a demonstrated commitment to corporate social responsibility. 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 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.us.boehringer-ingelheim.com

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.



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