Problem Atrial Fibrillation
Format Multicenter, parallel-group, randomized controlled trial
Treatment Dabigatran
Control Warfarin
Population 18,113 patients
Inclusion criteria AF
Age >75 years or 65-74 years with T2DM, HTN, or CAD
One of:
-Previous stroke or TIA
-LVEF <40%
-NYHA class II-IV within 6 months
Exclusion criteria Severe valvular disease
Stroke within 14 days
Severe stroke within 6 months of screening
Condition conveying an increased risk of hemorrhage
Creatinine clearance <30 ml/min
Active liver disease
Follow-up Median 2.0 years
Primary endpoint Stroke or systemic embolism
Primary safety endpoint of major bleeding
Secondary endpoint(s) Stroke
Vascular death
All-cause mortality
Major hemorrhage
Details .
Brief summary: 150mg Dabi less stroke than warfarin, similar bleeding.
PAPER: Dabigatran versus Warfarin in Patients with Atrial Fibrillation
Date 17 Sep 2009
Journal N Engl J Med. 2009 Sep 17;361(12):1139-51
Information 150mg Dabigatran
-significantly lower rate of stroke & embolism
-similar rate of major bleeding
110mg Dabigatran
-similar rate of stroke & embolism
-lower rate of major bleeding
Both doses
-significantly reduced risk of intracranial haemorrhage
-increased risk of GI bleeding
-dyspepsia most common side-effect