Randomised controlled trial: extended-duration dabigatran is non-inferior to warfarin and more effective than placebo for symptomatic VTE

Commentary on: Schulman S, Kearon C, Kakkar AK, et al.. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013;368:709–718. RE-MEDY and RE-SONATE trials. Context In patients with idiopathic deep vein thrombosis (DVT) or pulmonary embolism (PE), extending the duration of warfarin beyond the initial 3–6 months of anticoagulation significantly reduces the risk for recurrence.1 2 Dabigatran is an oral direct-thrombin inhibitor that has been shown to be as effective as warfarin in the first 6 months after a venous thromboembolism (VTE).3 However, its efficacy and safety for extended therapy is not known. Methods Two parallel double-blinded randomised controlled studies were conducted, evaluating extended therapy with dabigatran versus warfarin (RE-MEDY or active-control study), or dabigatran versus placebo (RE-SONATE or placebo-control study). Both studies included patients (≥18 years) who had received ≥3 months of anticoagulation for symptomatic proximal DVT...
Source: Evidence-Based Medicine - Category: Internal Medicine Authors: Tags: EBM Aetiology, Clinical trials (epidemiology), Drugs: cardiovascular system, Stroke, Venous thromboembolism, Pulmonary embolism Source Type: research