New Trial Confirms Function For Pradaxa In Venous Thromboembolism

A new research aids support a part for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in individuals with venous thrombosis (VTE).  The RE-COVER II trial, published on the web in Circulation, confirms the locating of the earlier and extremely equivalent RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and powerful as warfarin for the treatment of  deep vein thrombosis (DVT) and pulmonary embolism (PE). Dabigatran is at present authorized only for the remedy of stroke prevention in sufferers with non-valvular atrial fibrillation.

In RE-COVER II two,589 patients with acute VTE were  randomized to dabigatran or warfarin following normal heparin treatment for 5 to eleven days. At 6 months the fee of recurrent VTE and connected deaths was two.3% in the dabigatran group versus two.two% in the warfarin group (HR one.08, CI .64 – 1.80 p&lt0.001 for noninferiority). There have been no important variations in the incidence of deaths, adverse occasions, and acute coronary syndromes.

Main bleeding, the main safety endpoint, occurred in 1.2% of the dabigatran group and 1.7% of the warfarin group (HR .69. CI .36 – 1.32). There was a important reduction in complete bleeds: 15.six% versus 22.1% (HR .67, CI .56 – .81).

A pooled examination of both RE-COVER trials turned up equivalent hazard ratios: recurrent VTE: 1.09 (CI 0.76 – one.57), main bleeding: .73 (CI .48 – 1.11), and complete bleeds: .70 (CI .61 – .79).

The findings are broadly steady with the VTE trials for the other new oral anticoagulants– apixaban (Eliquis, BristolMyers Squibb and Pfizer), rivaroxaban (Xarelto, Johnson &amp Johnson) and edoxaban (Daiichi Sankyo), in accordance to the authors. In all the trials the newer agents were noninferior to warfarin in efficacy and had decrease bleeding prices.

In an accompanying editorial, Peter Verhamme and Henri Bounameaux write that RE-COVER II is the last of the phase III trials studying the newer anticoagulants in the acute therapy of VTE. They agree with the examine authors that all the drugs have now shown noninferiority to warfarin along with much less bleeding.

A single clinically important issue is that apixaban and rivaroxaban have been studied making use of a single-drug approach, creating these drugs preferable in patients for whom outpatient remedy is feasible. The new agents, they publish, “offer individuals, physicians and healthcare techniques an effective, safer, and far more hassle-free remedy for acute VTE.”

New Trial Confirms Function For Pradaxa In Venous Thromboembolism