Boehringer Ingelheim announced on 20 March that the last patient has completed treatment in the phase III RE-LY (Randomized evaluation of long term anticoagulant therapy) study.
This study compared the long-term efficacy and safety of the oral direct thrombin inhibitor dabigatran etexilate with the current standard therapy, warfarin for the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation. Dabigatran etexilate is an oral anticoagulant in phase III development for stroke prevention in AF, as well as several other therapeutic areas.
RE-LY is the largest AF stroke prevention trial to date. The study enrolled 18,113 patients in more than 900 centres in 44 countries worldwide between December 2005 and December 2007. Data will now be analysed and results are expected to be presented later this year at the European Society of Cardiology (ESC) Congress, taking place in Barcelona, Spain, from 29 August until 2 September.
RE-LY investigated whether dabigatran etexilate (two blinded doses) is effective for stroke prevention in patients with non-valvular atrial fibrillation and at least one other major risk factor for stroke (previous stroke, transient ischaemic attack, heart failure, diabetes, high blood pressure or age >75). Patients enrolled in the study were followed for a minimum of one year.
The primary outcome of the trial is the combined incidence of stroke (including haemorrhagic) and non-CNS systemic embolism. Secondary outcomes include all death, incidence of stroke (including haemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction and vascular death (including death from bleeding). Additional safety endpoints include major and minor bleeding events (including intracerebral haemorrhage).
Dabigatran etexilate is a direct reversible thrombin inhibitor (DTI), in a new class of oral anticoagulants being studied in the prevention and treatment of acute and chronic thromboembolic diseases. DTIs provide an anticoagulant effect by specifically and selectively blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot formation – conversion of fibrinogen to fibrin.
Dabigatran etexilate is not approved by the FDA. Dabigatran etexilate is approved as Pradaxa in over 28 countries for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip or elective total knee replacement surgery.