Boehringer Ingelheim Pharmaceuticals, Inc. Release: New Real-World Safety And Efficacy Data On Pradaxa® (dabigatran etexilate mesylate) To Be Presented At American Heart Association Scientific Sessions

RIDGEFIELD, Conn., Nov. 10, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that two separate comparative analyses evaluating the safety and efficacy of Pradaxa® (dabigatran etexilate mesylate) to reduce the risk of stroke in non-valvular atrial fibrillation (NVAF) patients in real-world clinical settings will be presented at the American Heart Association's Scientific Sessions 2014 in Chicago (Nov. 15-19).

Researchers from the U.S. Department of Defense will present findings from a retrospective analysis evaluating the safety and efficacy of PRADAXA versus warfarin in 25,586 NVAF patients based on the Military Health System database. In a second analysis, researchers from Brigham & Women's Hospital will present interim findings on 38,378 NVAF patients in two health insurance databases evaluating treatment with PRADAXA in real-world routine clinical care.

Additionally, new research will be presented on idarucizumab*, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for PRADAXA. The study assesses the effect of idarucizumab on the ability to generate fibrin, a protein involved in blood clotting, at a wound site in healthy volunteers.

Detailed information regarding the data presentations includes:

Poster Presentations
Monday, November 17

  • Session:APS.213.06 - Anticoagulants for Atrial Fibrillation and Venous Thromboembolic Disease: Care and Outcomes
    South Hall A2 Core 2, 3:00-4:30 p.m.
    • The Comparative Safety and Effectiveness of the Oral Anticoagulant (OAC) Dabigatran versus Warfarin Utilized in a Large Healthcare System in Non-valvular Atrial Fibrillation (NVAF) Patients (T.C. Villines); Abstract No. 18353

Tuesday, November 18

  • Session:APS.211.04 - Behavioral Risk Factors and CVD Risk II
    South Hall A2 Core 2, 3:00-4:30 p.m.
    • Safety and Effectiveness of Dabigatran Relative to Warfarin in Routine Care (J.D. Seeger); Abstract No. 16227
  • Session APS.709.03 - Thrombosis and Coagulation: Clinical
    South Hall A2 Core 7, 3:00-4:30 p.m.
    • Effect of Dabigatran on the Ability to Generate Fibrin at a Wound site and its Reversal by Idarucizumab, the Antidote to Dabigatran, in Healthy Volunteers: An Exploratory Marker of Blood Loss (J. van Ryn); Abstract No. 18403
    • Bloods Loss in Dabigatran Anticoagulated Pigs With Polytrauma is Significantly Reduced by Early Therapy With Activated and Non-activated Prothrombin Complex Concentrates (O. Grottke); Abstract No. 18544
    • Efficacy of Dabigatran versus Warfarin in Patients With Acute Venous Thromboembolism and Thrombophilia: A Pooled Analysis of RE-COVER® and RE-COVER II (S. Schulman); Abstract No. 18594
    • Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Adolescents: An Open-label Phase IIa Study (M. Lobmeyer); Abstract No. 18482

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;
  • for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days;
  • to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated




Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant


Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • use of indwelling epidural catheters
  • concomitant use of other drugs that affect hemostasis, such as non-steroidal antiinflammatory 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
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated.

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

Increased Risk of Thrombotic Events after Premature Discontinuation
Premature 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.

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 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 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 Exposure
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.
Reduction of Risk of Stroke/Systemic Embolism in NVAF

  • 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.

Treatment and Reduction in the Risk of Recurrence of DVT/PE

  • For patients with CrCl <50 mL/min, avoid use of PRADAXA and concomitant P-gp inhibitors

The most serious adverse reactions reported with PRADAXA were related to bleeding.

  • 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).


  • Rates of any GI bleeds were higher in patients receiving PRADAXA 150 mg vs warfarin and placebo
  • In the active-controlled studies, there was a higher rate of clinical myocardial infarction (MI) in PRADAXA patients [20 (0.66/100) patient-years)] vs warfarin [5 (0.17/100 patient-years)]. In the placebo-controlled study, there was similar rate of non-fatal and fatal clinical MI in PRADAXA patients [1 (0.32/100 patient-years)] vs placebo [1 (0.34/100 patient-years)].
  • GI adverse reactions were similar in patients receiving PRADAXA 150 mg vs warfarin.  They were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage).

Drug hypersensitivity reactions were reported in 0.1% of patients receiving PRADAXA.

Other Measures Evaluated
In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 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 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 and more than 47,400 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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

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

RE-LY® and RE-COVER® are registered trademarks of Boehringer Ingelheim International GmbH and used under license.

RE-COVER II is a trademark of Boehringer Ingelheim International GmbH and used under license.

* Idarucizumab is the proposed International Nonproprietary Name (pINN).

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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