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Dabigatran for the Prevention of Thromboembolic Complications in the Elderly: A RE-LY-able Alternative to Warfarin?

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On October 19, 2010, the Food and Drug Administration approved dabigatran (Pradaxa) for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The use of warfarin sodium has been considered a mainstay therapy for the prevention of thromboembolic complications secondary to AF. Despite its efficacy among oral antithrombotic agents for the prevention of thromboembolic complications secondary to AF, only about 67% of candidates for warfarin receive appropriate antithrombotic therapy. Dosed twice daily, dabigatran offers recipients the ability to forego regular international normalized ratio coagulation monitoring as well as eliminating dietary restrictions (i.e., vitamin K) associated with warfarin therapy. In a 2011 guideline update, dabigatran has been recognized by the American College of Cardiology and the American Heart Association as a useful alternative to warfarin in patients with AF who are at risk for thromboembolic complications and who are without severe renal or hepatic impairment. The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study is the only direct, prospective, comparative clinical trial of dabigatran versus warfarin to date that enrolled subjects for the purpose of examining the ability of dabigatran to prevent stroke and thromboembolic complications associated with nonvalvular AF. Currently, the published literature has not adequately defined which patient populations would be most suitable to treat with dabigatran. While dabigatran has a place in the therapeutic prevention stroke and systemic embolism associated with AF, careful consideration of the risks and benefits of therapy is recommended.
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Keywords: AF = Atrial fibrillation; ARR = Absolute risk reduction; Atrial fibrillation; CAD = Coronary artery disease; CCB = Calcium channel blocker; CCT = Controlled clinical trial; CV = Cardiovascular; Cardiovascular; DM = Diabetes mellitus; Dabigatran; GFR = Glomerular filtration rate; HF = Heart failure; HR = Hazard ratio; HTN = Hypertension; Heart Failure; INR = International normalized ratio; MI = Myocardial infarction; Myocardial infarction; NNT = Number needed to treat; NYHA = New York Heart Association; RE-LY = Randomized Evaluation of Long-Term Anticoagulation Therapy Study; TIA = Transient ischemic attack; VKA = Vitamin K antagonist; Warfarin; cTTR = Centerbased time in therapeutic range

Document Type: Research Article

Publication date: 2012-06-01

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  • The Consultant Pharmacist® is the official peer-reviewed journal of the American Society of Consultant Pharmacists. It is dedicated exclusively to the medication needs of the elderly in all settings, including adult day care, ambulatory care, assisted living, community, hospice, and nursing facilities. This award-winning journal is a member benefit of ASCP. Individuals who are not members and wish to receive The Consultant Pharmacist® will want to consider joining ASCP.
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