Amsterdam - according to the European society of cardiology (ESC), announced at the annual meeting of a key international randomized clinical trials (http://www.chemdrug.com/sell/24/) as a result, the new factor Ⅹ a inhibitor class according to the degree of sand in the treatment of acute venous thromboembolism (VTE), the role of more and more big, Relying on excellent performance to stand out from similar drugs (http://www.chemdrug.com/).
Edusaban was not inferior to standard treatment at 12 months of follow-up, but its safety was comparable to that of the first two factor ⅹ A direct inhibitors, Rivaroxaban (Xarelto) and Apixaban (Eliquis) in the treatment of venous thromboembolism (VTE). The edusaban trial also demonstrated an important new feature of this class of drugs (http://www.chemdrug.com/) : approximately one-third of patients enrolled with severe pulmonary embolism resulting in right ventricular dysfunction responded to edusaban with a statistically significant benefit compared to warfarin.
The trial, called Hokusai-VTE, randomized 4,921 patients with deep vein thrombosis and 3,319 patients with pulmonary embolism from January 2010 to October 2012 at 439 centers in 37 countries. The mean age of the patients was 56 years, slightly more than half were male, and all patients received heparin therapy for a median of 7 days. In this study, all subjects were treated with enoxaparin or regular heparin iv for at least 5 days, discontinued approximately 5 days later, and continued with oral warfarin or edusaban. This treatment strategy is in contrast to previous pivotal studies of Rivaroxaban and apixaban, which initiated oral drug therapy in patients with acute VTE.
The endpoint was VTE recurrence. After 1 year, 3.2% of 4,118 patients randomized to edusaban and 3.5% of 4,122 patients randomized to warfarin had a primary efficacy endpoint, meeting the non-inferiority criteria for the study. Is a blood clot in the preset and speculate with right ventricular dysfunction in patients with pulmonary embolism group, according to their size blood clot anatomy and blood sodium N terminal forebrain peptide level judgment, in accordance with the degree of sand class treatment with warfarin therapy group during the follow-up of recurrent VTE incidence of 3.3% and 6.2% respectively, with significant statistical differences.
The primary safety outcome of this study was the incidence of clinically significant major bleeding or non-major bleeding, which was 8.5% in the edusaban group and 10.3% in the warfarin group, respectively. The relative risk decreased by 19% in the edusaban group, which was statistically significantly superior to warfarin. Class safety data also shows that, in accordance with the degree of sand treatment group patients with a total of five times or retroperitoneal bleeding in the brain, and warfarin treatment group has 22 hemorrhage, with colenso doctor's point of view, the difference is real, attributed to warfarin on blood coagulation factor Ⅶ role, and in other new validation factor Xa inhibitors in clinical trials also observed the results.
The Hokusai-VTE study is unique among the oral ⅹ A factor inhibitor trials, and is the only study that allows flexibility in the setting of anticoagulant therapy, followed all patients for 12 months, and risk stratified patients using imaging and biomarkers to demonstrate efficacy in patients with severe pulmonary embolism.
Dr. Zoghbi said in an interview that the results of the study, which showed superior efficacy in patients with the most severe pulmonary embolism, reinforce the belief that edusaban is not inferior but may have an advantage in high-risk patients. Dr. Konstantinides said the data collected so far on the three oral ⅹ A inhibitors suggest that all three drugs are "not inferior to standard treatment and are probably superior in terms of safety." But he also warned that These new drugs (http://www.chemdrug.com/) needs to show patients for treatment and the quality of life satisfaction and by reducing the number of VTE patients hospitalized again reduce overall health costs (http://www.chemdrug.com/invest/253/), Justify the high cost.Hokusai - VTE research daiichi sankyo (http://www.chemdrug.com/), the company (http://www.chemdrug.com/company/) developed in accordance with the degree of the sand. Dr Buller, who is also the lead investigator in the pivotal trials of Rivaroxaban and Apisaban VTE, said he received payments from Daiichi Sankyo, Bayer, Boehringer Ingelheim, Pfizer/Bristol-Myers Squibb, Isis and Thrombogenics. Dr. Zoghbi had no information to disclose. Dr. Konstantinides is a speaker for Boehringer Ingelheim, Bayer, and Pfizer/Bristol-Myers Squibb.
Expert comments: Edusaban will continue the development trend of new oral anticoagulants
The results of the Hokusai-VTE study appear to confirm the hypothesis that edusaban is not inferior to warfarin and, equally important, that edusaban is superior in high-risk patients with severe pulmonary embolism. The advent of oral factor X inhibitors has given doctors a whole new idea for treatment. These drugs are easier to administer than warfarin, diet does not interfere with treatment, and blood is not drawn. It seems that the benefits of the novel factor ⅹ inhibitors may be class-like. The results of these drugs are consistent, but there is a limitation of relatively high cost. Hopefully, this cost difference will not eventually become a stumbling block to patient treatment.
Increasingly, doctors and patients in the United States will routinely use these drugs to treat VTE or in other Settings, such as preventing blood clots and preventing strokes in patients with atrial fibrillation. In June 2013, 10 to 12 percent of patients with atrial fibrillation were receiving a new class of oral anticoagulants, including Dabigatran (Pradaxa). As knowledge and acceptance of these drugs increases, their use will gradually increase to replace warfarin.
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