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´:
