Dabigatran Etexilate: Re-LY trial

Dabigatran Etexilate: Re-LY trial

Dabigatran Etexilate: Re-LY trial – Compared dabigatran with warfarin those with atrial fibrillation.

Features of dabigatran

1. Oral prodrug – converted to dabigatran
2. Reversible, direct thrombin inhibitor
3. Plasma half-life of dabigatran is 14-17 hrs
4. Once-daily dosing
5. Renal excretion
6. Bioavailability only ~4-5%

Re-LY trial (Randomized Evaluation of Long term anticoagulant therapy)

Dabigatran vs warfarin for preventing stroke and systemic embolic events in atrial fibrillation.

The RE-LY trial compared oral dabigatran etexilate with warfarin @ INR 2.0-3.0 in patients with non-valvular atrial fibrillation who are at moderate-to-high risk of stroke. The study completed enrollment of 18,113 patients, from 1,000 centers, in 44 countries between December 2005 and December 2007. It was a non-inferiority trial and the median follow up was 2 years.

The study concluded that in patients with atrial fibrillation, 110 mg of dabigatran was associated with stroke and systemic embolism rates similar to that of warfarin with lower rates of major bleeding. The higher dose of 150 mg was associated with lower rates of stroke and systemic embolism, with similar rates of major bleeding [1].

Reference

1. Stuart J Connolly, Michael D Ezekowitz, Salim Yusuf, John Eikelboom, Jonas Oldgren, Amit Parekh, Janice Pogue, Paul A Reilly, Ellison Themeles, Jeanne Varrone, Susan Wang, Marco Alings, Denis Xavier, Jun Zhu, Rafael Diaz, Basil S Lewis, Harald Darius, Hans-Christoph Diener, Campbell D Joyner, Lars Wallentin, RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51.