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Wealth of worldwide evidence on Pradaxa® including first clinical data on long-term efficacy and safety of a novel oral anticoagulant to be
INGELHEIM, Germany - Wednesday, October 31st 2012 [ME NewsWire]

Presentation of RELY-ABLE® study results: First and only long-term efficacy & safety data on a novel oral anticoagulant for stroke prevention in atrial fibrillation (AF) to be announced in the Clinical Science: Special Reports session
New sub-analyses from the 18,000 patient landmark trial RE-LY® also discussed
Real-world clinical data for VTE prevention in total knee or hip replacement to be presented

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

Widely anticipated results from RELY-ABLE®, the first long-term follow-up study of a novel oral anticoagulant treatment for stroke prevention in AF, will be among the numerous clinical reports on Pradaxa® (dabigatran etexilate) to be presented at the American Heart Association’s (AHA) Scientific Sessions in Los Angeles from 3-7 November.1 The wealth of evidence being presented for Pradaxa® at this year’s AHA sheds light on the clinical, long-term and real-world benefits of the treatment for patients at risk for thromboembolic events worldwide.

The RELY-ABLE® results presented are the first randomized follow-up data indicating how a novel oral anticoagulant is performing over more than four years of treatment duration.1These important results will provide knowledge on the consistency of benefits offered by the treatment and support physicians in their search for optimal stroke protection. RELY-ABLE® is the long-term extension study of the RE-LY® trial, one of the largest phase III trials to investigate the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.1-3

RELY-ABLE® oral presentation information:


Lead Author

Presentation details

Randomized Comparison of the Effects of Two Doses of Dabigatran Etexilate on Clinical Outcomes Over 4.3 Years: Results of the RELY-ABLE Double-blind Randomized Trial

Stuart J Connolly, McMaster Univ, Hamilton, ON, Canada

CS.04. Clinical Science: Special Reports: Valvular Heart Disease, PAD, Atrial Fibrillation: International Perspectives

Wed, Nov 7, 11:55 - 12:05 PT

The RELY-ABLE® study conclusions will be discussed during an exclusive online data webcast available on demand for medical media from 9 a.m. CET on Thursday 8 November –

Additional studies on Pradaxa® being presented at the AHA Scientific Sessions

In addition to RELY-ABLE®, several reports including novel RE-LY® subanalyses, clinical real-world experience and preclinical studies on Pradaxa® will be presented at the AHA Scientific Sessions. Of particular note will be results from real-world practice examining the safety and efficacy of Pradaxa® for the prevention of venous thromboembolism after total knee or hip replacement,4 as well as updates from the Boehringer Ingelheim Research & Development Programme regarding an antibody fragment antidote for rapid reversal of the anticoagulant effect of Pradaxa®.5

Further Pradaxa® abstracts being presented at AHA:*


RE-LY® trial sub-analyses:

Comparison of Dabigatran versus Warfarin in Diabetic Patients with Atrial Fibrillation: Results from the RE-LY Trial Lead Author: H. Darius, Poster No. 15937, Sunday 4 November, 3:00 p.m. - 4:30 p.m.
Dabigatran Versus Warfarin in Very Elderly Patients with Atrial Fibrillation: Results from the RE-LY Trial Lead Author: M. Coppens, Oral Presentation 15537, Monday 5 November, 9:30 a.m. - 9:45 a.m.
Balancing the Benefits and Risks of Two Doses of Dabigatran Compared with Warfarin in Atrial Fibrillation Lead Author: J. Eikelboom, Presentation 14433, 11:30 a.m. - 11:45 a.m.
Importance of Persistent Elevation of Cardiac Biomarkers in Atrial Fibrillation - A RE-LY Substudy Lead Author: Z. Hijazi, Oral Presentation 14808, Tuesday 6 November, 4:45 p.m. - 5:00 p.m.

Other key AF abstracts:

Cluster Randomized Controlled Trial to Test The Effect of a Multifaceted Comprehensive Cardiovascular Care Intervention on Clinical Outcomes in Atrial Fibrillation Patients Receiving Dabigatran Lead Author: R. Nieuwlaat, Oral Presentation 12618, Monday 5 November, 9:00 a.m. - 9:15 a.m.
Regional Variation in Ischemic Stroke Rates and Oral Anticoagulant Use Among the Non-Valvular Atrial Fibrillation Medicare Population Lead Author: K. Fitch, Poster No. 12992, Tuesday 6 November, 9:30 a.m. – 11:00 a.m., presented by K. Siu
Association between Outpatient Visits Following Hospital Discharge and Readmissions among Medicare Beneficiaries with Atrial Fibrillation Lead Author: M. Hubbard, Poster No. 11367, Tuesday 6 November, 9:30 a.m. - 11:00 a.m., presented by K. Siu
Incidence of Bleeding Events in Patients with Atrial Fibrillation Lead Author: T. Murray-Thomas, Poster No. 14178, Tuesday 6 November, 3:00 p.m. - 4:30 p.m., presented by A. Clemens
Cost-Effectiveness of Dabigatran Etexilate versus Rivaroxaban for Stroke and Systemic Embolism Risk Reduction in Atrial Fibrillation: A US Third Party Payer Perspective Lead Author: D. Walker, Poster No. 14964, Wednesday 7 November, 9:30 a.m. – 11:00 a.m.

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

Safety and Efficacy of Once Daily 220 mg Dabigatran Etexilate in a Real-World Non-Interventional Study of More Than 5000 Patients After Total Knee or Hip Replacement Lead Author: N. Rosencher, Poster No. 10001, 3:00 p.m. - 4:30 p.m.


The Influence on Plaque Formation and Endothelial Function in ApoE-Deficient Mice by Direct Thrombin Inhibition with Dabigatran Lead Author: M.T. Kratz, Poster No. 14060, Sunday 4 November, 9:30 a.m. - 11:00 a.m.
Reversal of Anticoagulant Activity of Dabigatran and Dabigatran-induced Bleeding in Rats by a Specific Antidote (Antibody Fragment) Lead Author: J. van Ryn, Oral Presentation 9928, Monday 5 November, 9:15 a.m. - 9:30 a.m.
Successful Reversal of Dabigatran-Induced Bleeding by 3-Factor Coagulation Concentrates in a Rat Tail Bleeding Model: Lack of Correlation with ex vivo Markers of Anticoagulation Lead Author: J. van Ryn, Oral Presentation 11955, Monday 5 November, 11:30 a.m. - 11:45 a.m.

* Abstracts will be available on the AHA Scientific Sessions Website on Saturday, November 3, 2012


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


Boehringer Ingelheim GmbH

Corporate Communications

Media + PR

Julia Meyer-Kleinmann

Phone: +49 6132 77 8271



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