"Dabigatran versus Warfarin in Patients with Atrial Fibrillation". The New England Journal of Medicine. 2009. 361(12):1139-1151. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
In patients with atrial fibrillation and a risk of stroke, does dabigatran produce similar or better outcomes compared to warfarin?
In patients with atrial fibrillation, dabigatran at a dose of 110 mg had similar rates of stroke and systemic embolism as warfarin, with lower rates of major hemorrhage. Dabigatran at 150 mg reduced the rates of stroke and systemic embolism compared with warfarin, with similar rates of major hemorrhage.
Warfarin has been a standard treatment for the prevention of stroke in patients with atrial fibrillation, but it requires regular monitoring and dose adjustments. Dabigatran, an oral direct thrombin inhibitor, has predictable pharmacokinetics and does not require routine monitoring. The RE-LY trial evaluated noninferiority (for the 110 mg dose) and superiority (for the 150 mg dose) of dabigatran compared with warfarin.
As of the knowledge cut-off date, various guidelines have adopted dabigatran as a therapeutic option for stroke prevention in non-valvular atrial fibrillation, typically providing it as an alternative to warfarin and other newer oral anticoagulants.
Multicenter, randomized, noninferiority and superiority trial N=18,113 patients with atrial fibrillation and risk of stroke Dabigatran 110 mg (n=6015), dabigatran 150 mg (n=6076), and warfarin (n=6022) Median follow-up: 2.0 years Primary outcome: Stroke or systemic embolism
Inclusion Criteria: - Atrial fibrillation and ≥1 stroke risk factors Exclusion Criteria: - Severe valve disorders, recent stroke, high bleeding risk, creatinine clearance <30 mL/min, or liver disease Baseline Characteristics - Mean age of 71 years - 63.6% male - Prior vitamin K antagonist therapy: 50% - Mean CHADS2 score: 2.1
- Dabigatran 110 mg or 150 mg, twice daily, double-blind - Warfarin, targeted INR of 2.0-3.0, unblinded
Primary Outcome: Stroke or systemic embolism - Dabigatran 110 mg: 1.53% per year - Dabigatran 150 mg: 1.11% per year (superior to warfarin) - Warfarin: 1.69% per year
- Major bleeding: Lower with dabigatran 110 mg, similar with 150 mg compared to warfarin - Hemorrhagic stroke: Lower with both dabigatran doses - Myocardial infarction: Higher with dabigatran
- Open-label nature for warfarin may have introduced bias - Higher rates of MI and gastrointestinal bleeding with dabigatran, particularly the 150 mg dose - Variable quality of INR control across different centers
Boehringer Ingelheim (manufacturer of dabigatran)
Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009;361(12):1139-1151. doi:10.1056/NEJMoa0905561.