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RE-COVER Study: New anticoagulant drug dabigatran is a safe effective alternative to warfarin for the treatment of Venous thromboembolism
Venous thromboembolism is the umbrella term for deep vein thrombosis (blood clots in the legs and pulmonary embolism (blood clots in the lungs
Results of the RE-COVER study showed that twice daily doses of 150 mg dabigatran etexilate (Pradaxa) was as effective as well-controlled warfarin for the treatment of venous thromboembolism (VTE). Unlike warfarin, dabigatran does not require regular blood tests or dose adjustments, nor does it interact with many common foods or medicines. A total of 30 of the 1274 patients randomly assigned to receive dabigatran (2.4%), as compared with 27 of the 1265 patients randomly assigned to warfarin (2.1%), had recurrent venous thromboembolism.
The trial also assessed various safety endpoints points included bleeding events, acute coronary syndromes and results of liver-function tests. Major bleeding was comparable between dabigatran etexilate (20 patients, 1.6%) and warfarin (24 patients, 1.9%). However when all bleeds (including major, clinically relevant and minor bleeds) were compared, dabigatran etexilate showed a significant 29% reduction compared to warfarin. The numbers of deaths, acute coronary syndromes, and abnormal liver-function tests were similar in the two groups. Adverse events leading to discontinuation of the study drug occurred in 9.0% of patients assigned to dabigatran and in 6.8% of patients assigned to warfarin. In common with the RE-LY trial comparing dabigatran to warfarin for the prevention of stroke in atrial fibrillation patients, rates of dyspepsia were higher in the dabigatran than the warfarin group.
The RE-COVER trial results were presented at the recent Society for Hematology congress in New Orleans and simultaneously published in The New England Journal of Medicine (for further details see http://content.nejm.org/cgi/content/abstract/361/24/2342; subscription required to access full article).
EINSTEIN-Extension study
Results from the EINSTEIN-Extension study, demonstrate that the factor Xa inhibitor rivaroxaban (Xarelto), when compared to placebo, significantly reduced the risk of a recurrent symptomatic venous thromboembolism (VTE).
Venous thromboebolism is the umbrella term for deep vein thrombosi (blood clots in the legs and pulmonary embolism (blood clots in the lungs.
The 1197 patients randomized for inclusion in the trial had previously completed 6 or 12 months of standard treatment with a vitamin K antagonist (or VKA, such as warfarin) for an acute episode of VTE or had participated in the ongoing Phase III EINSTEIN-DVT or EINSTEIN-PE trials, in which patients were treated with either rivaroxaban or a VKA, for the same duration of time. Patients were randomly assigned to receive either 20 mg of rivaroxaban dosed once-daily, or a placebo, and were evaluated for an additional 6 or 12 months.
During the treatment period, symptomatic recurrent VTE events occurred in 42 (7.1%) of the placebo treated patients and in 8 (1.3%) of the rivaroxaban recipients – a relative risk reduction (RRR) of 82%. After the stop of study medication, 6 symptomatic recurrent VTE events occurred in each group during the one month observational period.
Major bleeding did not occur in placebo patients and was observed in 4 (0.7%) rivaroxaban recipients. None of these bleeding events were fatal or in a critical site. Clinically relevant non-major bleeding was noted in 7 (1.2%) and 32 (5.4%) of the placebo and rivaroxaban recipients, respectively. Two (0.3%) patients in the placebo group died versus 1 (0.2%) in the rivaroxaban group. No patients were observed to have raised liver enzymes and there were no differences in the incidence of cardiovascular-related events between the two treatment groups.
The EINSTEIN-Extension trial results were presented at the recent Society for Hematology congress in New Orleans. Further information is available via the ASH website http://ash.confex.com/ash/2009/webprogram/Paper25669.html |