Dabigatran: A Review of Clinical and Pharmacoeconomic Evidence Critical Pathways in Cardiology, 10/07/2011

Reddy P et al. – These observations suggest that dabigatran is a valuable addition to the therapeutic armamentarium for stroke prevention in selected patients with atrial fibrillation although caution should be exercised given the limited data on this agent and higher cost.

• A single trial has studied patients at risk for stroke associated with nonvalvular atrial fibrillation; in this trial, dabigatran 150 mg twice a day met the criteria for superiority over warfarin in preventing stroke and systemic embolism while reducing the rate of hemorrhagic stroke with a similar risk of major bleeding.
• For the treatment of venous thromboembolism, dabigatran 150 mg twice a day had comparable efficacy and safety versus warfarin.
• In contrast, dabigatran was less effective than enoxaparin 30 mg twice a day in venous thromboembolism prevention in orthopedic surgery.
• Advantages of dabigatran over warfarin include its lack of need for routine laboratory monitoring, a fixed–dose regimen, and potentially fewer clinically important drug interactions.
• Concerns include higher incidences of dyspepsia and gastrointestinal bleeding, twice–daily dosing, and lack of effective antidote.
• Additional drawbacks include higher drug cost versus warfarin, accumulation in case of renal impairment, higher discontinuation rates due to adverse events, and limited long–term safety and trial data.
• From a payer perspective, overall costs will be higher with dabigatran compared with warfarin, but dabigatran does meet the threshold to be considered a cost–effective therapy.
• In addition, the lack of need for regular laboratory monitoring is a quality of life advantage for patients on dabigatran.