Phase III RE-LY study results to be presented at the European Society of Cardiology Congress

Aug 26 2009

Results of the Phase III RE-LY(R) (Randomized Evaluation of Long-Term Anticoagulant Therapy, Warfarin, Compared to Dabigatran) study will be presented at the European Society of Cardiology (ESC) Congress in Barcelona on Sunday, Aug. 30. The primary objective of RE-LY was to assess the safety and efficacy of the investigational oral direct thrombin inhibitor, dabigatran etexilate, against the current standard therapy, warfarin, for the prevention of stroke in patients with atrial fibrillation (AF).

Atrial fibrillation affects approximately 2.3 million Americans and can increase the risk of stroke five-fold. Top-line findings from the 18,113 patient RE-LY study will be featured in an ESC press briefing on Sunday, Aug. 30 at 8:00 a.m. CEST, with the full results presented in a "Hot-Line" session at 11:00 a.m. CEST. The study will also be simultaneously published in a leading peer-reviewed medical journal.

Dabigatran etexilate is an investigational oral anticoagulant in Phase III development for stroke prevention in AF and several other therapeutic areas, including prevention of atherothrombotic events in patients with acute coronary syndrome, as well as primary prevention, secondary prevention and treatment of venous thromboembolism. Dabigatran etexilate is not yet approved by the U.S. Food and Drug Administration.

In addition to the primary findings, a RE-LY sub-analysis of treatment naive patients will also be presented during a "Clinical Trial Update" session on Wednesday, Sept. 2 at 8:00 a.m. CEST.

About RE-LY: The largest AF outcomes trial to date

RE-LY was a global, Phase III, randomized trial of 18,113 patients enrolled in more than 900 centers in 44 countries, investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin - INR 2.0-3.0 - (open label) for stroke prevention. Patients with non-valvular AF and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age greater than or equal to 75 years, age greater than or equal to 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension) were enrolled in the study for two years with a minimum follow-up period of one year.

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism. Secondary outcome measures included a composite of incidence of stroke (including hemorrhagic), systemic embolism and all death, as well as a composite of incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding). Additional safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction, and other adverse events.