RE-LY trial on dabigatran etexilate

RE-LY trial on dabigatran etexilate

RE-LY trial on dabigatran etexilate: RE-LY (Randomized Evaluation of Long Term anticoagulation Therapy) trial [Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51] was a comparison of dabigatran versus warfarin in patients with atrial fibrillation. The objective was to compare the safety and efficacy of dabigatran with warfarin for the prevention of stroke and systemic embolism. The study was designed as an international, multicenter randomized phase III noninferiority trial. Fixed doses of dabigatran 110 mg and 150 mg were compared in a blinded fashion. Warfarin dose adjustment was done in an unblinded fashion. A total of 18,113 patients were enrolled in the RE-LY study. Patients with atrial fibrillation documented on electrocardiography at screening or within 6 months and with at least one of the following characteristics were enrolled: previous stroke or transient ischemic attack (TIA), left ventricular ejection fraction of < 40%, New York Heart Association (NYHA) class II or higher heart failure symptoms within the 6 months before screening, age 75 years and above or age 65-74 years plus diabetes mellitus, hypertension or coronary artery disease. Presence of severe heart-valve disorder, stroke within 14 days or severe stroke within 6 months before screening, condition that increased the risk of hemorrhage, creatinine clearance less than 30 mL/min, active liver disease and pregnancy were exclusion criteria for the RE-LY trial. Dabigatran was given in a blinded fashion with capsules containing either 110 mg or 150 mg of the drug to be taken twice daily. Warfarin was given in an unblinded fashion in tablets of 1, 3 or 5 mg and was adjusted locally to maintain an INR (international normalized ratio of prothrombin time) of 2.0 to 3.0. INR was measured at least monthly and the treatment duration was 2 years.

The RE-LY trial on dabigatran etexilate concluded that in patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with stroke rates similar to warfarin (P < 0.001 for noninferiority), but with a lower rates of major hemorrhage. On the other hand, dabigatran given at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism with similar rates of major hemorrhage.

Dyspepsia occurred more frequently with dabigatran compared to warfarin. Myocardial infarction was more frequent with dabigatran but the difference was not statistically significant.