Dabigitran and the radiology department
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KeywordsClopidogrel Enoxaparin Dabigatran Total Knee Replacement Dabigatran Etexilate
Dabigitran is a direct thrombin inhibitor which was licensed in Ireland in March 2008 for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery . Dabigitran replaces the use of subcutaneous low molecular weight heparin, and works by increasing the activity of autologous antithrombin III. This licensing followed the RE-NOVATE, RE-MODEL AND RE-MOBILIZE trials which showed that dabigatran etexilate was comparable to enoxaparin for the prevention of VTE following hip and knee arthroplasty, with similar low-bleeding rates .
Furthermore, in April of this year, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the alteration to the current licensing for dabigitran, which allows for its use in “prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation” . This indication was previously approved by the United States Food and Drug Administration in October 2010. This may lead to dabigatran being licensed for use as an attractive alternative to warfarin in many patients.
Patients attending our department for diagnostic and interventional radiology procedures are currently screened for use of anticoagulation medications such as aspirin, warfarin, clopidogrel and heparin. In our practice, we have encountered patients on dabigitran therapy for both licensed and non-licensed indications. As the use of this drug is becoming more frequent, we would recommend that dabigatran therapy is also screened prior to interventional procedures, in order to prevent bleeding complications. The manufacturers (Boehringer Ingelheim) have recommended discontinuing dabigitran at least 24 h before “invasive or surgical procedures”. Patients with renal impairment may require discontinuation of therapy up to 5 days prior to the procedure as the drug is primarily excreted renally .
We feel it is important that practicing radiologists are aware of this drug as it becomes more widely available within our patient population.
- 1.European Medicines Agency. Summary of product characteristics for pradaxa 110 mg hard capsules. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000829/human_med_000981.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 Cited 20 July 2011
- 3.European Medicines Agency. CHMP post-authorisation summary of positive opinion for pradaxa. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000829/WC500105283.pdf Cited 21 July 2011
- 4.Boehringer Ingelheim GmbH. Pradaxa—dabigatran etexilate. Guide for surgery and interventions. http://global.pradaxa.com/surgery-and-interventions/prescriber-guide.html?width=&height=Cited 20 July 2011