Current and emerging strategies in the management of venous thromboembolism: benefit-risk assessment of dabigatran

• Published in: Vascular health and risk management 2015-01, Vol.11 (default), p.271-282
• Main Author: Fanola, Christina L
• Format: Article
• Language: English
• Subjects: Acute Coronary Syndrome - chemically induced; Anticoagulants; Anticoagulants - therapeutic use; Antithrombins - adverse effects; Antithrombins - pharmacokinetics; Antithrombins - pharmacology; Antithrombins - therapeutic use; Comorbidity; dabigatran; Dabigatran - adverse effects; Dabigatran - pharmacokinetics; Dabigatran - pharmacology; Dabigatran - therapeutic use; deep venous thrombosis; Drug therapy; Health risk assessment; Hemorrhage - chemically induced; Humans; Joint surgery; Methods; Mortality; novel oral anticoagulants; oral anticoagulation; Patient care; Patient outcomes; pulmonary embolism; Pulmonary embolisms; Renal Dialysis; Renal Insufficiency, Chronic - epidemiology; Review; Risk Assessment; Thromboembolism; venous thromboembolism; Venous Thromboembolism - drug therapy; Venous Thromboembolism - epidemiology; Venous Thromboembolism - prevention & control; Vitamin K - antagonists & inhibitors
• ISSN: 1178-2048; 1176-6344; 1178-2048
• DOI: 10.2147/VHRM.S62595

Venous thromboembolism (VTE) is a disease state that carries significant morbidity and mortality, and is a known cause of preventable death in hospitalized and orthopedic surgical patients. There are many identifiable risk factors for VTE, yet up to half of VTE incident cases have no identifiable risk factor and carry a high likelihood of recurrence, which may warrant extended therapy. For many years, parenteral unfractionated heparin, low-molecular weight heparin, fondaparinux, and oral vitamin K antagonists (VKAs) have been the standard of care in VTE management. However, limitations in current drug therapy options have led to suboptimal treatment, so there has been a need for rapid-onset, fixed-dosing novel oral anticoagulants in both VTE treatment and prophylaxis. Oral VKAs have historically been challenging to use in clinical practice, with their narrow therapeutic range, unpredictable dose responsiveness, and many drug-drug and drug-food interactions. As such, there has also been a need for novel anticoagulant therapies with fewer limitations, which has recently been met. Dabigatran etexilate is a fixed-dose oral direct thrombin inhibitor available for use in acute and extended treatment of VTE, as well as prophylaxis in high-risk orthopedic surgical patients. In this review, the risks and overall benefits of dabigatran in VTE management are addressed, with special emphasis on clinical trial data and their application to general clinical practice and special patient populations. Current and emerging therapies in the management of VTE and monitoring of dabigatran anticoagulant-effect reversal are also discussed.