Presented at AHA's Scientific Sessions 2012, first long-term results from the RELY-ABLE study demonstrate that advantages of PRADAX (dabigatran etexilate) treatment are maintained over more than four years PRADAX is the first and only novel oral anticoagulant supported by long-term clinical data Sustained benefits for both doses allow for persistent brain protection and tailored treatment according to patient needs
BURLINGTON, ON, Nov. 8, 2012 /CNW/ - Data from the *RELY-ABLE study have provided additional data to support the long-term safety profile and efficacy of PRADAX (dabigatran etexilate) for stroke prevention in patients with non-valvular atrial fibrillation (AF). **1 The new long-term results presented at the American Heart Association's (AHA) Scientific Sessions, are highly consistent with the findings from the landmark RE-LY trial, the basis for the approval of PRADAX in countries all over the world. The rates of stroke and hemorrhage observed during the 2.3 years of blinded follow-up in RELY-ABLE correspond to the initial RE-LY results, supporting the benefit of both doses of PRADAX for tailored brain protection.1-3
The combined data from RE-LY and RELY-ABLE equates to over four years of experience and provides the most comprehensive evaluation of the benefits and safety of any novel oral anticoagulant for stroke prevention in AF to date.1
"Most patients with atrial fibrillation need life-long anticoagulant treatment to be protected from ischemic stroke. The unique long-term data we now have for dabigatran etexilate are reassuring for both patients and physicians," said RELY-ABLE lead investigator Professor Stuart Connolly, Director of the Division of Cardiology at McMaster University, Hamilton, Ontario. "RELY-ABLE shows that the results seen in RE-LY continue to be observed during long-term follow up. We see similar rates of stroke or systemic embolism and similar rates of major bleeding with similar rates of intracerebral bleeding and intracranial hemorrhage."
*Data from RELY-ABLE has not been reviewed by Health Canada
**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. Lead author: Stuart J Connolly. CS.04. Clinical Science: Special Reports: Valvular Heart Disease, PAD, Atrial Fibrillation: International Perspectives
The international multi-centre RELY-ABLE study followed 5,851 patients on PRADAX for more than 27 months after completion of the RE-LY trial. It examined the long-term benefits of the two treatment doses (110mg bid and 150mg bid) in an ongoing randomized and blinded comparison.1
The results from RELY-ABLE support sustained dose benefits in the long-term use of PRADAX:1
The consistent incidences of ischemic and hemorrhagic stroke as well rates of intracranial bleeding observed indicate that PRADAX provides ongoing protection to the brain. Furthermore, both doses of PRADAX had similar net clinical benefit and mortality rates.1
"The results from the RELY-ABLE study are consistent with the excellent results we have seen in the RE-LY trial and strongly support the long-term safety profile and efficacy of PRADAX for stroke prevention in atrial fibrillation," stated Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Physicians can be confident in the sustained brain protection and treatment advantages offered by both doses of PRADAX, and can tailor their treatment according to patient needs, as the first long-term clinical data for a novel oral anticoagulant show."
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RELY-ABLE®: Unprecedented long-term data support safety profile and sustained efficacy of PRADAX® for stroke ...