Recommendations on Use of Dabigatran for Atrial Fibrillation
Dabigatran is a new direct thrombin inhibitor that has been approved for use in Canada for the prevention of stroke and systemic embolism in patients with atrial fibrillation, as an alternative to warfarin. It has now been approved by Manitoba Pharmacare under Part III (exception drug status) for patients “in whom (a) Anticoagulation is inadequate following a reasonable trial on warfarin; OR (b) Anticoagulation with warfarin is contraindicated or not possible due to inability to regularly monitor via International Normalized Ratio (INR) testing (i.e. no access to INR testing services at a laboratory, clinic, pharmacy, and at home).”
Dabigatran has advantages over warfarin for some patients including: moderately greater efficacy for preventing stroke, fixed dosing without requirement for monitoring, and few drug and diet interactions. It also has some disadvantages including: need for twice daily administration, accumulation in renal insufficiency, more frequent GI side effects, lack of antidote in the event that bleeding occurs, and cost.
Dabigatran has not been approved for use in a number of situations in which warfarin is used, including: mechanical heart valves, deep vein thrombosis, pulmonary embolism, acute coronary syndromes, antiphospholipid syndrome, or cardiac mural thrombus. It is contraindicated in pregnancy and in renal failure (eGFR < 30ml/min). Like any anticoagulant, it should not be administered to any patient with active bleeding or very high risk of bleeding.A series of recommendations on the appropriate use of this new agent have been developed by the Section of Hematology/Oncology and Section of Cardiology, University of Manitoba. They address the following:
These recommendations are intended for health care professionals. They are intended to give guidance on the use of dabigatran, but do not take the place of clinical judgment in individual cases.
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