Oral factor Xa inhibitors Sample Clauses

Oral factor Xa inhibitors. Rivaroxaban (BAY 59-7939) is an orally administered direct factor Xa inhibitor with a bioavail- ability of 80 percent and peak plasma concentrations occurring 2.5 to 4 hours following administration. As in the case of previous agents mentioned in this category, it does not require routine monitoring. It has proved favorable to enoxaparin in the prevention of ve- nous thromboembolism in patients undergoing orthopedic surgery, without increasing the bleeding complications265. A phase II clinical trial in ACS patients demonstrated a beneficial effect in terms of ischemic events reduction along with a dose-dependent increased bleeding risk266. Phase III clinical trials are currently testing its efficacy in the setting of ACS267, recurrent thromboembolism prevention268 and prevention of stroke in the setting of non-valvular atrial fibrillation269. Apixaban (BMS-562247-01) has also been tested for the prevention of thromboembolism, mainly in the setting of orthopedic surgery. In a recently published study, apixaban did not meet the pre-specified non-inferiority criteria compared to enoxaparin but its use was associ- ated with lower rates of clinically relevant bleeding270. However, in another phase III clinical trial also involving knee-replacement surgery patients, apixaban proved more effective than enoxaparin without increasing bleeding risk271. Further studies, assessing its efficacy in the setting of atrial fibrillation272 and ACS patients273 are on their way. Edoxaban (DU-176b) has completed a number of phase II clinical trials testing its efficacy in non-valvular atrial fibrillation274 and phase II and III trials in thromboembolism preven- tion following orthopedic surgery275, 276. A large phase III trial (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48, Engage AF-TIMI 48) comparing edoxaban to warfarin in terms of stroke prevention in patients with non-valvular atrial fibrillation is currently recruiting patients277, with results expected in 2012. SR123781A is a synthetic hexadecasaccharide with a mixed profile of AT-dependent anti-Xa and anti-thrombin activities. In a dose-ranging study for the prevention of thromboembolism following orthopedic surgery (NCT00338897), it demonstrated a reasonable risk to benefit ratio compared to enoxaparin278. LY517717 and Betrixaban (PRT-054021) are two more agents of this category that have been tested in phase II trials against enoxaparin ...
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Related to Oral factor Xa inhibitors

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