From the Guidelines
Pradaxa (dabigatran) is recommended after ischemic stroke related to atrial fibrillation, with a typical dosage of 150 mg taken twice daily, though a reduced dose of 110 mg twice daily may be prescribed for elderly patients or those with kidney impairment. This recommendation is based on the most recent and highest quality study, which suggests that dabigatran is effective in reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 1. The study also notes that dabigatran has a lower risk of hemorrhagic strokes compared to warfarin, and that the benefits of dabigatran compared to warfarin are similar across different patient groups, including those with paroxysmal, persistent, and permanent atrial fibrillation.
Some key points to consider when prescribing Pradaxa include:
- Kidney function tests should be performed before starting Pradaxa, and patients should be monitored for signs of bleeding or other adverse effects 2
- Patients should be educated on the importance of consistent timing of doses and the dangers of missed doses or prolonged interruptions of therapy 2
- Concomitant antiplatelet therapy with oral anticoagulant therapy is not routinely recommended in patients with atrial fibrillation due to increased bleeding risk, unless there is a specific additional medical indication 2
- The CHA2DS2-VASc score can be used to identify patients at high risk of stroke, and the HAS-BLED score can be used to identify patients at high risk of bleeding 3
Overall, Pradaxa is a effective and safe option for stroke prevention in patients with atrial fibrillation, and its use should be considered in patients who have experienced an ischemic stroke related to atrial fibrillation. Regular follow-up appointments are necessary to monitor treatment effectiveness and potential side effects.
From the Research
Pradaxa Recommendation After Stroke
- The studies suggest that Pradaxa (dabigatran etexilate) is recommended for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 4, 5, 6.
- According to the RE-LY trial, dabigatran etexilate dosages of 110 and 150 mg twice daily were noninferior to warfarin with regard to the risk of stroke or systemic embolism 4.
- The study also found that the higher dosage of dabigatran etexilate was associated with a significantly lower risk of stroke or systemic embolism than warfarin, with no significant between-group difference in the risk of major bleeding 4.
- Another study found that dabigatran etexilate 150 mg twice daily is more effective than warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation, and generally well tolerated 5.
- A nationwide pharmacoepidemiological study found that dabigatran was similarly effective as warfarin in prevention of ischemic stroke, TIA or systemic embolism, with a lower risk of major or clinically relevant non-major bleeding 7.
- A study comparing the effectiveness and safety of apixaban, dabigatran, and rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and previous stroke or transient ischemic attack found that dabigatran had a nonsignificant effect on hazards of major bleeding versus warfarin 8.
Safety and Efficacy
- The studies suggest that Pradaxa is generally well tolerated, with a lower risk of major bleeding compared to warfarin 4, 5, 7.
- However, one study found that the higher dosage of dabigatran etexilate was associated with a higher rate of gastrointestinal bleeding than warfarin 5.
- Another study found that dabigatran was associated with fewer intracranial bleedings, fewer gastrointestinal bleedings, and fewer other bleedings compared to warfarin 7.