Long-term benefits of preventing venous thromboembolic events

Abstract

Background:

Venous thromboembolism (VTE) and its long-term secondary complications are major health problems associated with high rates of morbidity and mortality and considerable costs for healthcare systems. Many patients receive suboptimal therapy, despite the availability of established and effective agents (including low molecular weight heparins, unfractionated heparin, fondaparinux and vitamin K antagonists) and evidence-based, internationally recognised guidelines. Limited knowledge of guidelines, concerns about bleeding risks and the inconvenience of parenteral administration and routine coagulation monitoring contribute to non-adherence to guidelines. Newer oral anticoagulants such as rivaroxaban, dabigatran etexilate, apixaban and edoxaban, which do not have the limitations of established anticoagulants, have been developed.

Method:

Phase III randomised controlled trials for the treatment of acute VTE or for secondary prevention of recurrent VTE were identified in the PubMed and ClinicalTrials.gov databases. The search was limited to phase III studies and performed up to 26 March 2012 with the terms ‘rivaroxaban OR Xarelto’, ‘dabigatran OR Pradaxa’, ‘apixaban OR Eliquis’ and ‘edoxaban OR DU-176b OR Lixiana’.

Findings:

A total of ten phase III studies, four published (three rivaroxaban, one dabigatran), three completed with results presented at recent congresses (dabigatran), and three ongoing (two apixaban, one edoxaban) were identified. Published and completed studies showed that rivaroxaban and dabigatran provided effective and convenient short-term treatment for deep vein thrombosis and VTE, respectively, when compared with standard of care, and showed superiority for long-term prevention of recurrent VTE when compared with placebo. Currently, rivaroxaban is the only newer anticoagulant that has been approved in Europe for the treatment of deep vein thrombosis and prevention of recurrent VTE.

Conclusions:

Based on results of completed trials, rivaroxaban and dabigatran both may reduce the incidence of secondary complications of VTE and associated socioeconomic costs. Introduction of these newer anticoagulants is likely to have a substantial impact on clinical practice.

Keywords::

• Anticoagulation
• Pharmacoeconomics
• Recurrence
• Rivaroxaban
• Secondary prevention
• Venous thromboembolism

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Erratum (Corrigendum)

Transparency

Declaration of funding

This study was funded by Bayer HealthCare Pharmaceuticals and Janssen Research & Development, LLC.

Declaration of financial/other relationships

A.T.C. is a medical consultant, and has received consultancy and clinical trial funding from pharmaceutical companies, including Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi, GSK, Johnson & Johnson, Mitsubishi Pharma, Pfizer, Portola, Sanofi-Aventis, Schering-Plough, and Takeda. He is an advisor to the UK Government Health Select Committee, the All-Party Working Group on Thrombosis, the Department of Health, and the NHS, on the prevention of VTE. He is also an advisor to Lifeblood: The Thrombosis Charity and is the founder of the European educational charity, the Coalition to Prevent VTE.

CMRO peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

Claudia Wiedemann, PhD, provided editorial support with funding from Bayer HealthCare Pharmaceuticals and Janssen Research & Development, LLC.