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Long-Term Dabigatran in Patients with Atrial Fibrillation

Summary and Comment |
August 14, 2013

Long-Term Dabigatran in Patients with Atrial Fibrillation

  1. Beat J. Meyer, MD

Dabigatran's track record in preventing stroke extends to observational follow-up of more than 4 years.

  1. Beat J. Meyer, MD

In the manufacturer-funded randomized trial known as RE-LY, dabigatran was shown to be noninferior to warfarin in patients with atrial fibrillation (AF) at a median follow-up of 2 years (JW Card Sep 1 2009). The annual rate of stroke or systemic embolism in that trial was 1.53% with 110-mg dabigatran, 1.11% with 150-mg dabigatran, and 1.69% with warfarin. Now, in the RELY-ABLE follow-up study, involving 5851 patients with AF who had completed RE-LY and had not permanently discontinued the study medication (almost half of those originally randomized), researchers extended the analysis of the dabigatran recipients for an additional 2.3 years.

After the additional follow-up, the annual rate of stroke or systemic embolism was similar between the 110-mg dabigatran group (1.60%) and the 150-mg group (1.46%). The annual rate of major hemorrhage differed slightly but significantly between the two groups (2.99% on 110 mg, 3.74% on 150 mg), but the annual rate of hemorrhagic stroke was similar (0.14% and 0.13%, respectively), as was the annual rate of death (3.10% and 3.02%).

Comment

Although subject to the inherent limitations of observational findings, these are the best available long-term data for any new oral anticoagulant to date. They suggest a favorable safety and efficacy profile of dabigatran in patients with atrial fibrillation.

  • Disclosures for Beat J. Meyer, MD at time of publication Leadership positions in professional societies CentraMed Organization (President)

Citation(s):

Reader Comments (1)

Ribeiro,Diogo Ney Physician, Psychiatry, Florianópolis,SC,Brazil

I'm a AF patient and use 20 mg per day of dabigratan................

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