Dabigatran 110mg or 150mg twice daily vs Warfarin - stoke or systemic embolism

DABIGATRAN 110MG OR 150MG TWICE DAILY VS. WARFARIN (TO MAINTAIN AN INR OF 2-3), PATIENTS WITH NON VALVULAR AF, STROKE OR SYSTEMIC EMBOLISM

Study population:

Patients with non valvular AF

Mean CHADS2 score 2.1

CHADS2 score 3-6 (33%)

Approx age 71 years

Comments:

This means that treating 333 or 91 patients with dabigatran instead of warfarin for 2 years might prevent one stroke or systemic embolism (depending on the dose used), and treating 83 or 250 patients with dabigatran instead of warfarin for 2 years might prevent one major bleeding episode (depending on the dose used). Note, however, that the warfarin group were within therapeutic range only 64% of the time.

The 110 mg twice daily dose is licensed if:

age > 80 years or

concomitant verapamil. May also be considered based on an individual assessment of the thromboembolic risk and the risk of bleeding

NNH, with respect to major bleeding, 80 (for 110 mg) and 250 (for 150 mg)