What is the efficacy and safety of dabigatran (Pradaxa) use in patients with atrial fibrillation (Afib) (AF)?

Updated: Nov 18, 2019
  • Author: Lawrence Rosenthal, MD, PhD, FACC, FHRS; Chief Editor: Jeffrey N Rottman, MD  more...
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Dabigatran (Pradaxa) is a direct oral thrombin inhibitor. The RE-LY study evaluated the efficacy and safety of two different doses of dabigatran relative to warfarin in more than 18,000 patients with AF. Patients were randomized to one of three arms: (1) adjusted-dose warfarin, (2) dabigatran 110 mg twice daily (BID), or (3) dabigatran 150 mg BID. Dabigatran 110 mg was noninferior to warfarin for the primary efficacy endpoint of stroke or systemic embolization, whereas dabigatran 150 mg was significantly more effective than warfarin or dabigatran 110 mg. Major bleeding occurred significantly less often with dabigatran 110 mg than with warfarin; dabigatran 150 mg had similar bleeding to that of warfarin. [75, 76]

A meta-analysis by Uchino and Hernandez evaluated the risk of myocardial infarction or acute coronary syndrome (ACS) with the use of dabigatran. The results suggest the risk of myocardial infarction or ACS was similar when using revised RE-LY trial results. Dabigatran is associated with an increased risk of myocardial infarction or ACS in an extensive range of patients when tested against different controls. [77]

A different meta-analysis involving more than 1000 patients found that major bleeding complications were generally less critical and more manageable in patients being treated with dabigatran than in those on warfarin therapy. For example, in patients treated with dabigatran, the worst major bleeds tended to be gastrointestinal, whereas in patients treated with warfarin, most of the worst bleeds were intracranial and therefore more difficult to treat. In addition, among patients with major bleeds, the dabigatran patients spent less time in intensive care and had a lower mortality rate than did the warfarin patients. [78, 79]

The US Food and Drug Administration (FDA) has approved the 150 mg BID dose—but not the 110 mg BID dose—of dabigatran for the management of patients with AF. The 75 mg BID dose has also been approved for patients with moderate renal failure (creatinine clearance of 15-29 mL/min). Patients with AF who are not candidates for dabigatran include those with prosthetic heart valves or hemodynamically significant valve disease, severe renal failure (creatinine clearance ≤15 mL/min), or advanced liver disease.

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