Dabigatran etexilate: what do hospitalists need to know?

Dabigatran etexilate (dabigatran) is a novel, oral, reversible, direct thrombin inhibitor that exhibits several advantages over warfarin for therapeutic anticoagulation. The predictable pharmacokinetic profile and minimal food and drug interactions of dabigatran allow for a fixed-dosing regimen and obviate the need for routine laboratory monitoring. Dabigatran has been approved in the United States for prevention of stroke in patients with nonvalvular atrial fibrillation and in the European Union and other countries for primary prevention of thromboembolic events after total knee or hip replacement. More indications for the use of dabigatran are under review by regulatory authorities and are undergoing active clinical investigation. Due to its rapid onset of action, dabigatran may omit the need for a parenteral anticoagulant for acute treatment of thromboembolic conditions. Because wide-scale use of dabigatran is expected in the near future, hospitalists need to familiarize themselves with this agent. The lack of a standardized reliable laboratory method to monitor the anticoagulant effects of dabigatran complicates verifying compliance, measuring the effects of drug interactions, evaluating cases of dabigatran toxicity, and conducting preoperative evaluations. The lack of an antidote to dabigatran complicates the management of toxicity and makes it largely supportive. The elimination of dabigatran is dependent on renal function, with the potential for drug accumulation and toxicity with renal impairment. The noninferiority design of the clinical trials that evaluated dabigatran and the absence of long-term safety and efficacy data and issues related to the cost effectiveness of dabigatran should all be considered when prescribing this agent.