NDLI: A benefit-risk assessment of dabigatran in the prevention of venous thromboembolism in orthopaedic surgery.

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A benefit-risk assessment of dabigatran in the prevention of venous thromboembolism in orthopaedic surgery.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Schulman, Sam Majeed, Ammar
Description	Country affiliation: Canada Author Affiliation: Schulman S ( Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada. schulms@mcmaster.ca)
Abstract	Dabigatran etexilate is a novel orally administered anticoagulant that exerts its action through reversible direct thrombin inhibition. This anticoagulant has been approved for prophylaxis against venous thromboembolism (VTE) after hip or knee arthroplasty, and in a few countries also for atrial fibrillation. This article reviews the efficacy and safety of dabigatran for the prophylaxis of VTE-indication compared with data on the most common current regimen with low-molecular-weight heparin (LMWH), specifically enoxaparin. Alternative prophylactic agents are also discussed. The results regarding efficacy and safety are very similar for dabigatran and LMWH. Bleeding and gastrointestinal reactions are the most frequently reported adverse events with a comparable incidence on LMWH and are probably the result of surgery and anaesthaesia. No adverse event that is specific for dabigatran has been observed in these studies, although dyspepsia has been reported as significantly more frequent than warfarin in long-term studies on other indications. The fact that dabigatran has no antidote has so far not been a problem in patients undergoing orthopaedic surgery. The use of the lower dose of dabigatran (150 mg) appears beneficial to reduce the risk of bleeding in patients over 75 years of age and in those with moderate renal impairment to avoid drug accumulation. The convenience of oral administration is an advantage for dabigatran over LMWH, particularly for extended prophylaxis up to 1 month after surgery. In conclusion, the benefit-risk profile of dabigatran is favourable for use as prophylaxis against VTE after major orthopaedic surgery with its convenient oral administration without need for laboratory monitoring and a low risk of bleeding or other adverse events.
File Format	HTM / HTML
ISSN	01145916
Issue Number	6
Volume Number	34
e-ISSN	11791942
Journal	Drug Safety
Language	English
Publisher	Springer
Publisher Date	2011-06-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Toxicology Anticoagulants Administration & Dosage Adverse Effects Benzimidazoles Venous Thromboembolism Drug Therapy Prevention & Control Beta-alanine Analogs & Derivatives Animals Dabigatran Humans Orthopedic Procedures Risk Assessment Etiology Journal Article Review
Content Type	Text
Resource Type	Article
Subject	Toxicology Pharmacology Pharmacology (medical)

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