In a nutshell
This study compared the safety and efficacy of dabigatran (Pradaxa) versus warfarin (Coumadin) in the prevention of stroke. Patients with atrial fibrillation of both Asian and non-Asian ethnicity were included in this analysis.
Some background
Atrial fibrillation is considered a major risk factor for stroke. Atrial fibrillation is a heart rhythm disturbance that can lead to the formation of blood clots in the heart's upper chambers (also called the atria). Sometimes, pieces may break off these clots and travel to the brain blocking the blood supply and causing a stroke.
Anticoagulants are a class of drugs used to prevent blood clot formation. Since patients with atrial fibrillation often develop clots, they are put on anticoagulants to lower the risk of stroke. However, anticoagulation needs close monitoring with blood tests (such as the International Normalized Ratio – or INR) to make sure there is not an increased risk of bleeding.
Typically, anticoagulation is done with drugs such as warfarin, that require frequent INR testing to make sure the amount of anticoagulation effect is adequate (not too much, not too little – usually an INR value between 2-3). Newer anticoagulants, such as dabigatran, have a more predictable anticoagulation response and are thought to be safer than standard warfarin.
Methods & findings
This large trial included 18113 patients, of which 2782 were of Asian ethnicity. All patients had atrial fibrillation. Patients were assigned to one of three groups:
– group 1 received standard warfarin treatment
– group 2 received dabigatran at a dose of 110 mg twice daily
– group 3 received dabigatran at a dose of 150 mg twice daily
Results showed during follow up, stroke occurred per year in 1.46% of patients on warfarin, 1.37% of patients on the 110mg dabigatran dose and 1.06% of patients on the 150 mg dabigatran dose. Stroke occurred more frequently in Asian patients than in non-Asian patients.
Major bleeding events occurred per year in 3.53% of patients on warfarin, 2.99% of patients on 110mg dabigatran and 3.52% of patients on 150mg dabigatran. Asian patients treated with dabigatran had fewer major bleeding events than corresponding non-Asian patients.
The bottom line
Results showed that dabigatran is an effective alternative to warfarin and may be safer when considering the risk of major bleeding events.
The fine print
The proportion of Asian patients was small (15% of participants), therefore these results are more relevant to non-Asian patients.
What’s next?
You should ask your doctor whether dabigatran anticoagulation is a good option for you.
Published By :
Stroke
Date :
Jun 06, 2013
