Implications of new anticoagulants in primary practice

Abstract

Summary Background: Effective prophylaxis and treatment of thromboembolic disorders remain suboptimal in many healthcare systems, partly owing to limitations of traditional anticoagulants. New oral anticoagulants have been developed and among these, rivaroxaban, apixaban and dabigatran etexilate are in the most advanced stage of clinical development. Method: A literature search using the PubMed and ClinicalTrials.gov databases was performed to identify English‐language publications. The search was performed up to 31 December 2011 with the terms rivaroxaban OR Xarelto, apixaban OR Eliquis and dabigatran OR Pradaxa. Ongoing, completed and published phase III randomised controlled trials were selected as the primary source of information for the clinical development programme of each drug. Results: The new oral agents demonstrate several advantages over traditional anticoagulants, including administration at fixed doses and no requirement for routine coagulation monitoring On the basis of phase III clinical trials, rivaroxaban, apixaban and dabigatran etexilate have been approved in many countries for the prevention of venous thromboembolism after hip and knee replacement surgery. Dabigatran etexilate and rivaroxaban have also been approved for the prevention of stroke and systemic embolism in patients with non‐valvular atrial fibrillation in Europe and the US. In addition, rivaroxaban has been approved in Europe for the treatment of acute deep vein thrombosis and prevention of recurrent venous thromboembolism. Approval of these agents and postapproval monitoring of their safety and efficacy will have implications for primary care. Conclusion: Rivaroxaban, apixaban and dabigatran etexilate offer the possibility of simplified prevention and treatment strategies for thromboembolic disorders in the outpatient setting.

The new factor Xa inhibitor: Apixaban

“…But since these drugs have a short half-life, reversal of action does not pose much problem except where rapid or acute reversal is needed. [19] These drugs still stand the ground of being useful anti-coagulants in thromboembolic disorders and are attractive therapeutic alternatives as compared to the current treatment options. It is important to remember that these agents should be tailored to the individual patient, and management of thrombotic disorders requires multi-modal approach.…”

Factor VIIa and Factor IXa Inhibitors as Anticoagulants: A Review

“…10 Rivaroxaban and Apixaban have been approved for treatment of venous thromboembolism (VTE), prevention after elective hip or knee replacement in adults, stroke prevention and systemic embolization in non-valvular atrial fibrillation. 11,12 Ximelagatran was the first oral direct thrombin inhibitor and had confirmed efficacy for prevention and treatment of VTE, stroke prevention and recurrent coronary events after acute myocardial infarction. But it was withdrawn by AstraZeneca in the year 2006 because of liver toxicity.…”

Safety of new oral anticoagulant drugs: a perspective

“…Other direct FXa inhibitors being investigated in clinical trials are edoxaban and betrixaban [Perez et al 2013], and are pending approval at the moment.…”

“…The pharmacokinetic data of these agents are summarized in Table 1 Perez et al 2013;Poulsen et al 2012].…”

“…Concomitant drugs and extrapolation from VKAs should be done while awaiting specific data. [2012], Lip et al [2012] and Perez et al [2013].…”