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06 December 2012 at 07:20 - Posted by Anonymous

New Pradaxa® safety and efficacy data to be featured at ‘Best of ASH’ session


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INGELHEIM, Germany - Wednesday, December 5th 2012 [ME NewsWire]

    New data to be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition with two Pradaxa® presentations selected as ‘The Best of ASH’:
        Analysis of management and outcomes of major bleeding events with Pradaxa® vs. warfarin
        Analysis of safety and efficacy of Pradaxa® for the prevention of recurrent pulmonary embolism and deep vein thrombosis in the one year post-treatment period
    Additional pre-clinical and real-world data presented add to the scientific body of evidence for Pradaxa®

(BUSINESS WIRE)-- For Non-US, Non-UK & Non-Canadian Media Only

The management of bleeding associated with the novel oral anticoagulants is one of the topics of interest at this year’s annual meeting of the American Society of Hematology. Important new data from the RE-LY® trial and pooled results from five Phase III studies will be presented, which compare the management and outcomes for Pradaxa® (dabigatran etexilate) and warfarin treatments.1 The data will provide insights into the prognosis of anticoagulated patients in case a major bleed should occur. The new data will be presented on December 8th at the ASH Annual Meeting and Exposition in Atlanta, Georgia, USA and are additionally featured in ‘The Best of ASH’ session, highlighting it among numerous clinical reports presented at the scientific meeting.

The results from a second study with Pradaxa®, the one-year post-treatment follow-up from the RE-SONATETM trial, will also be presented in the ‘The Best of ASH’ session. This data will shed light on the long-term risk of recurrence of deep vein thrombosis or pulmonary embolism after an extended maintenance therapy.2 The treatment of deep vein thrombosis or pulmonary embolism with Pradaxa® is part of an ongoing clinical development programme and is not yet approved.

‘BEST of ASH’ oral presentation information:

Title
         

Lead Author
         

Presentation details
    

Management and Outcomes of Major Bleeding on Dabigatran or Warfarin
         

Ammar Majeed, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden
         

Sat, Dec 8, 2012; 12:00 p.m. EST

Abstract No. 19, Oral Session: 332. Antithrombotic Therapy I

B405-B407, Level 4, Building B (Georgia World Congress Center)
    

Benefit of Extended Maintenance Therapy for Venous Thromboembolism with Dabigatran Etexilate Is Maintained Over 1 Year of Post-Treatment Follow-up
         

Sam Schulman, McMaster University, Hamilton, Canada
         

Sat, Dec 8, 2012: 12:30 p.m. EST

Abstract No. 21, Oral Session: 332. Antithrombotic Therapy I

B405-B407, Level 4, Building B (Georgia World Congress Center)
    

Additional studies on Pradaxa® being presented at the ASH Annual Meeting and Exposition

Furthermore, data evaluating the clinical experience with Pradaxa® and pre-clinical studies of dabigatran will be presented during the congress. Of particular note will be results from a real-world analysis examining the safety and efficacy of Pradaxa® for the primary prevention of deep vein thrombosis or pulmonary embolism after total knee or hip replacement, as well as the latest updates from the Boehringer Ingelheim Research & Development Programme, regarding the potential of a highly specific antibody fragment antidote for rapid reversal of the anticoagulant effect of Pradaxa® during critical care situations.

Details of the Pradaxa® data presentations:

ATRIAL FIBRILLATION

    Persistence Among Patients with Non-Valvular Atrial Fibrillation Beginning Dabigatran or Warfarin (Lead Author: K. M Francis, presented by K. Siu) [Abstract No. 365, Monday 10 December, Health Services and Outcomes Research Session, 8:00 a.m. EST]

Primary prevention of VENOUS THROMBOEMBOLISM in patients after total knee or hip replacement surgery:

    Real-World Study of Dabigatran Etexilate for Thromboprophylaxis in Over 5000 Hip or Knee Replacement Patients: Favourable Safety Profile in Subgroups with Different BMI, Renal Function and Age (Lead Author: N. Rosencher) [Abstract No. 1160, Saturday 8 December, Session 332 Antithrombotic Therapy: Poster I, 5:30 p.m. – 7:30 p.m. EST]
    Epidemiological Data on the Incidence of Co-Morbidities and Co-Medications in Patients Undergoing Total Hip or Knee Replacement Surgery: Real-World Study and Phase III Clinical Trials (Lead Author: N. Rosencher) [Abstract No. 2269, Sunday 9 December, Session 332 Antithrombotic Therapy: Poster II, 6:00 p.m. – 8:00 p.m. EST]

PRE-CLINICAL STUDIES:

    Reversal of Dabigatran’s Anticoagulant Activity in the Monkey by a Specific Antidote and Pharmacokinetic and Pharmacodynamic Modeling (Lead Author: J. Toth) [Abstract No. 22, Saturday 8 December, Session 332 Antithrombotic Therapy I, 12:45 p.m. EST]
    Acceleration of Dabigatran Elimination by Activated Charcoal Perfusion and Hemodialysis in a Pig Model (Lead Author: J. Lange) [Abstract No. 2272, Sunday 9 December, Session 332 Antithrombotic Therapy: Poster II, 6:00 p.m. – 8:00 p.m. EST]
    In Vitro Characterization, Pharmacokinetics and Reversal of Supratherapeutic Doses of Dabigatran-Induced Bleeding in Rats by a Specific Antibody Fragment Antidote to Dabigatran (Lead Author: J. van Ryn) [Abstract No. 3418, Monday 10 December, Session 332 Antithrombotic Therapy: Poster III, 6:00 p.m. – 8:00 p.m. EST]

Full details of the abstracts can be accessed via ASH Annual Meeting and Exposition website at https://ash.confex.com/ash/2012/webprogram/start.html

For more information on Pradaxa®, please visit www.newshome.com and follow the company on Twitter www.twitter.com/boehringer

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/05_december_2012dabigatranetexilate.html

Contacts

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Julia Meyer-Kleinmann

Phone: +49 6132 77 8271

E-mail: press@boehringer-ingelheim.com

Twitter: http://twitter.com/Boehringer

More information

www.boehringer-ingelheim.com

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