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Boehringer Ingelheim Presents New Data for Pradaxa® and its Specific Reversal Agent Idarucizumab (Praxbind®) at AHA Scientific Sessions 2017



RIDGEFIELD, Conn., Nov. 10, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced that important sub-analyses from three major trials in anticoagulation care will be presented at the American Heart Association (AHA) Scientific Sessions 2017 in Anaheim, California, November 11-15. In total, five abstracts investigating Pradaxa® (dabigatran etexilate mesylate) and its reversal agent, idarucizumab, marketed in the U.S. as Praxbind®, have been accepted.

"We look forward to sharing important new insights about Pradaxa and idarucizumab from RE-DUAL PCItm, RE-CIRCUITtm and RE-VERSE ADtm, three pivotal trials that have all been published in the New England Journal of Medicine this year," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The safety and efficacy of Pradaxa has already been well-established, and these sub-analyses add to the growing body of evidence on its clinical impact in patients with atrial fibrillation."

Details of the data presented at the AHA Scientific Sessions 2017 are as follows:

Abstract Title

Details

(Venue: Anaheim Convention Centre, Anaheim,

California, USA)

Subgroup analysis from the RE-DUAL

PCI trial:  Dual antithrombotic therapy with

dabigatran in patients with atrial fibrillation

undergoing percutaneous coronary

intervention

Session Title: New Insights into the Risks, Benefits, and

Costs of Antithrombotic Therapy

Session Date: Tuesday, November 14, 10:45 a.m. - 12:00 p.m.

Presentation Time: 11:00 a.m. - 11:10 a.m.

Location: Main Event I (Hall D, Main Building)

Speaker: Jonas Oldgren

 

Idarucizumab in dabigatran-treated patients

requiring emergency surgery or intervention:

Updated/final results from the RE-VERSE AD

study

Session Title: Cardiovascular Surgery Research: The Cutting Edge

Presentation Date: Monday, November 13, 5:30 p.m. - 5:40 p.m. 

Speaker: Jerrold Levy

Regional differences in patient characteristics

and outcomes during uninterrupted

anticoagulation with dabigatran versus

warfarin in catheter ablation of atrial

fibrillation: The RE-CIRCUIT study

Session Title: Stroke Risk Stratification and Prevention in Atrial Fibrillation 

Session Date: Tuesday November 14, 10:30 a.m. - 11:45 a.m. 

Location: Science and Technology Hall - Clinical Science Section

Speaker: Stefan H. Hohnloser

Idarucizumab is effective and safe in the

inhibition of dabigatran anticoagulation

in patients presenting with a gastrointestinal

bleeding: Insights from the RE-VERSE AD

study

Session Title: Clinical Studies and Trials for Prevention

Session Date:  Monday, November 13, 3:00 p.m. - 4:15 p.m.

Location: Clinical Science III Section, Science and Technology Hall

Speaker: Menno V. Huisman

Monitoring of safety and effectiveness of

dabigatran relative to warfarin in routine care

Session Title: EP.RFO.21 - Pharmacoepidemiology

Session Date: Monday, November 13, 1:30 p.m. - 2:40 p.m. 

Presentation Time: 2:30 p.m. - 2:45 p.m. 

Location: Science and Technology Hall - Population Science Forum

Speaker: Chandrasekar Gopalakrishnan

More information on the Boehringer Ingelheim data due to be presented or published at the AHA Scientific Sessions 2017 can be found here.

Idarucizumab is the first and only approved specific reversal agent for a novel oral anticoagulant currently available. It is approved as a specific reversal agent for Pradaxa by the U.S. Food and Drug Administration (FDA) under accelerated approval. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.

About Praxbind® (idarucizumab)

INDICATIONS AND USAGE
PRAXBIND is indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:

This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers.  Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Thromboembolic Risk

Re-elevation of Coagulation Parameters

Hypersensitivity Reactions

Risk in Patients with Hereditary Fructose Intolerance

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

Pregnancy and Nursing Mothers

Please see full Prescribing Information.

About Pradaxa® (dabigatran etexilate mesylate)

Indications and Usage
Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
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
(B) SPINAL/EPIDURAL HEMATOMA
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:

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.

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 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 and restart Pradaxa as soon as medically appropriate.

Risk of Bleeding

Hemodialysis can remove dabigatran; however clinical experience for hemodialysis as a treatment for bleeding is limited. Prothrombin complex concentrates or recombinant Factor VIIa 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

ADVERSE REACTIONS
The most serious adverse reactions reported with Pradaxa were related to bleeding.

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
Boehringer 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 top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

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. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.  

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, RE-VERSE ADtm, RE-DUAL PCItm and RE-CIRCUITtm under license.

SOURCE Boehringer Ingelheim


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