In a race to replace warfarin and smoothen management issues of thromboembolic disorders by avoiding need for stringent therapeutic monitoring, newer oral anticoagulants are making their debut in the market soon. Rivaroxaban (BAY 59-7939) along with two newly developed molecules, Apixaban and Dabigatran etexilate are oral form of anticoagulant agents with a convenient fixed once or twice daily dose regime. 1 Compare to Warfarin, these drugs do not require coagulation monitoring as being highly specific direct inhibitor of Factor Xa (Rivaroxaban, Apixaban) and Factor IIa (aka, Direct thrombin inhibitor - Dabigatran etexilate). Dabigatran is about to launch in market with completed phase 3 trial in orthopedics and currently running trials in stroke prevention 4.
Phase 3 trial, RECORD3 (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) data from 2531 patients, lead by Michael R. Lassen, MD announced today at the XXI International Society on Thrombosis and Haemostasis (ISTH) Congress showed once-daily rivaroxaban (Xarelto®) achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with enoxaparin, the current standard of care therapy [49% relative risk reduction (RRR) (p<0.001)]. 2 Importantly, rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6% and 0.5%, respectively). Considering potential hepatotoxiciy of direct thrombin inhibitors (i.e.: withdrawal of the direct thrombin inhibitor ximelagatran shortly after it reached the market 3), complete saftey profile of rivaroxaban is due till ongoing RECORD3 trial ends by 2007 end. To date, rivaroxaban is the most studied oral direct factor Xa inhibitor in development. More than 15,000 patients have been evaluated in the completed phase II programs and enrolled thus far in the phase III programs. More than 40,000 patients are expected to be evaluated in total. 4
Rivaroxaban is being jointly developed by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research &amp;amp; Development (J&JPRD), L.L.C.
References:
1. Rivaroxaban Looks Promising in DVT - Medscape Heartwire
2. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery - Pressnote at Bayer Inc. | ISTH 2007 website
3. AstraZeneca Decides to Withdraw Exanta™ (melagatran / ximelagatran)
4. Currently active clinical trials from ClinicalTrials.gov
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Phase 3 trial, RECORD3 (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) data from 2531 patients, lead by Michael R. Lassen, MD announced today at the XXI International Society on Thrombosis and Haemostasis (ISTH) Congress showed once-daily rivaroxaban (Xarelto®) achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with enoxaparin, the current standard of care therapy [49% relative risk reduction (RRR) (p<0.001)]. 2 Importantly, rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6% and 0.5%, respectively). Considering potential hepatotoxiciy of direct thrombin inhibitors (i.e.: withdrawal of the direct thrombin inhibitor ximelagatran shortly after it reached the market 3), complete saftey profile of rivaroxaban is due till ongoing RECORD3 trial ends by 2007 end. To date, rivaroxaban is the most studied oral direct factor Xa inhibitor in development. More than 15,000 patients have been evaluated in the completed phase II programs and enrolled thus far in the phase III programs. More than 40,000 patients are expected to be evaluated in total. 4
Rivaroxaban is being jointly developed by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research &amp;amp; Development (J&JPRD), L.L.C.
References:
1. Rivaroxaban Looks Promising in DVT - Medscape Heartwire
2. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery - Pressnote at Bayer Inc. | ISTH 2007 website
3. AstraZeneca Decides to Withdraw Exanta™ (melagatran / ximelagatran)
4. Currently active clinical trials from ClinicalTrials.gov
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