Dabigatran etexilate: a review of its use for the prevention of venous thromboembolism after total hip or knee replacement surgery.

Drugs
Celeste B Burness, Kate McKeage

Abstract

Dabigatran etexilate (Pradaxa®, Pradax™, Prazaxa®) is indicated for the primary prevention of venous thromboembolic (VTE) events in adults who have undergone elective total hip replacement (THR) or total knee replacement (TKR) surgery. This article reviews the clinical efficacy and tolerability of oral dabigatran etexilate in patients undergoing major orthopaedic surgery, as well as summarizing its pharmacological properties and results of a cost-utility analysis. The discussion of clinical trial data focuses on comparative trials with the EU approved dosage regimen of once-daily subcutaneous enoxaparin sodium 40 mg. Dabigatran etexilate is an oral prodrug of the potent, rapidly acting, reversible, competitive inhibitor of thrombin, dabigatran. Dabigatran has predictable and consistent anticoagulant effects and does not require routine coagulation monitoring or dose titration. In the large, randomized, double-blind, phase III, noninferiority trials, RE-MODEL, RE-NOVATE and RE-NOVATE II, oral dabigatran etexilate, at dosages of 150 and 220 mg once daily, initiated postoperatively was shown to be noninferior to subcutaneous enoxaparin sodium 40 mg once daily (initiated prior to surgery) with regard to the incidence of the composi...Continue Reading

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Citations

May 15, 2013·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·T SteinerR Veltkamp
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