title: Benefit-risk profile of non-vitamin K antagonist oral anticoagulants in the management of venous thromboembolism.
abstract: The prevention and treatment of venous thromboembolism (VTE) remains a clinical challenge, primarily owing to drawbacks associated with the use of heparins and vitamin K antagonists (VKAs). These and other factors, including a growing elderly population, mean that VTE presents a continuing burden to patients and physicians. Anticoagulant therapy is a fundamental approach for VTE management. Non-VKA oral anticoagulants, including the factor Xa inhibitors apixaban, edoxaban and rivaroxaban, and the thrombin inhibitor dabigatran, have been studied in phase III trials across a spectrum of thromboembolic disorders. These agents offer simplified care, with similar or improved efficacy and safety outcomes compared with heparins and vitamin K antagonists. There are several factors a physician must consider when prescribing an anticoagulant. An important consideration with all anticoagulant use is bleeding risk, especially in high-risk groups such as the elderly or those with renal impairment or cancer. In orthopaedic patients, other risks include a need for surgical revision or blood transfusion, or wound complications. Therefore, the clinical benefits of an anticoagulant should ideally be balanced with any risks associated with the therapy. Quantitative benefit-risk assessments are lacking, and owing to differences in trial design the non-VKA oral anticoagulants cannot be compared directly. Based on trial and "real-life" data, this review will summarise the clinical data for the non-VKA oral anticoagulants in the prevention and treatment of VTE, focusing on the balance between the benefits and risks of anticoagulation with these drugs, and their potential impact on VTE management.
authors.affiliation: Jan Beyer-Westendorf, Center for Vascular Diseases and Medical Clinic III, Dresden University Hospital "Carl Gustav Carus", Fetscherstraße 74, 01307 Dresden, Germany, Tel.: +49 351 4582236, Fax: +49 351 4585809, E-mail: jan.beyer@uniklinikum-dresden.de.
authors.forename: Jan
authors.initials: J
authors.lastname: Beyer-Westendorf
authors.forename: Walter
authors.initials: W
authors.lastname: Ageno
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects; D002986:Clinical Trials as Topic; D000069604:Dabigatran / Q000008:administration & dosage; D065427:Factor Xa Inhibitors / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D019637:Orthopedic Procedures; D011720:Pyrazoles / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D011728:Pyridones / Q000627:therapeutic use; D018570:Risk Assessment; D000069552:Rivaroxaban / Q000627:therapeutic use; D013844:Thiazoles / Q000627:therapeutic use; D013923:Thromboembolism / Q000188:drug therapy; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000188:drug therapy*; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011725:Pyridines; D011728:Pyridones; D013844:Thiazoles; D014812:Vitamin K; C522181:apixaban; D006493:Heparin; D000069552:Rivaroxaban; D000069604:Dabigatran; C552171:edoxaban
keywords: Benefit–risk assessment; non-VKA oral anticoagulants; real-life; thromboprophylaxis; venous thromboembolism