Document Detail

A benefit-risk assessment of dabigatran in the prevention of venous thromboembolism in orthopaedic surgery.
MedLine Citation:
PMID:  21585219     Owner:  NLM     Status:  MEDLINE    
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.
Sam Schulman; Ammar Majeed
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Drug safety     Volume:  34     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-18     Completed Date:  2011-10-03     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  449-63     Citation Subset:  IM    
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MeSH Terms
Anticoagulants / administration & dosage*,  adverse effects*
Benzimidazoles / administration & dosage*,  adverse effects*
Orthopedic Procedures / adverse effects
Risk Assessment
Venous Thromboembolism / drug therapy*,  etiology,  prevention & control*
beta-Alanine / administration & dosage,  adverse effects,  analogs & derivatives*
Reg. No./Substance:
0/Anticoagulants; 0/Benzimidazoles; 11P2JDE17B/beta-Alanine; I0VM4M70GC/dabigatran

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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