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Dabigatran is widely used for stroke prevention in atrial fibrillation. Dabigatran is no longer patent-protected in Canada and 2 generic formulations were recently approved by Health Canada. Branded dabigatran uses a complex formulation to maintain the acidic microenvironment required for maximal absorption. Consequently, food does not influence its bioavailability and the efficacy and safety of dabigatran are similar with or without concomitant intake of proton pump inhibitors (PPIs). Unfortunately, current bioequivalence criteria do not mandate testing of the generic formulations with food or with concomitant intake of PPIs; thus, the only data available for the approved generic products are in fasted, healthy volunteers. Without confirmation that the bioavailability of the generic dabigatran products is maintained in the presence of food or with coadministration of PPIs, it is uncertain whether they will afford patients the same protection from stroke as the branded product. Clinicians and patients must be made aware of this limitation to make informed prescribing decisions. The rules for establishing bioequivalence have not kept pace with the increasing complexity of pharmaceutical products; we urge regulators to update the regulatory process to ensure the therapeutic equivalence of generic products., (Copyright © 2018 Canadian Cardiovascular Society. All rights reserved.)

Dabigatran etexilate is a direct thrombin inhibitor that has been in clinical use for the prevention and treatment of venous and arterial thrombosis. Dabigatran allows for oral administration, has a rapid onset of action and has a predictable anticoagulant effect. Studies in healthy volunteers and in patients undergoing orthopedic surgery indicate that dabigatran has a predictable pharmacokinetic profile, allowing for a fixed-dose regimen without the need for coagulation monitoring. Dabigatran is approved in the EU and Canada for prophylaxis of thromboembolism in patients undergoing total hip and knee arthroplasties. The focus of this article is on the clinical data of using dabigatran as venous thromboprophylaxis in orthopedic surgery patients.