Pradaxa® (dabigatran etexilate) vs warfarin for the prevention of stroke
and systemic embolism in patients
with non-valvular atrial fibrillation:
The RE-LY Study
The RE-LY® (Randomized Evaluation of Long-term anticoagulant therapY) study compared dabigatran with warfarin in 18,113 patients with non-valvular atrial fibrillation (NVAF) across 44 countries worldwide. Importantly, the RE-LY study had a dedicated treatment arm for both Pradaxa® 110 mg b.d. and 150 mg b.d. enabling comparison of both doses with warfarin1–5
Pradaxa® prevention of stroke and
systemic embolism vs warfarin
The RE-LY study demonstrated that low-dose Pradaxa® 110 mg b.d. (n=6,015) was similar to warfarin (INR 2–3) (n=6,022) in reducing the risk of stroke and systemic embolism and ischaemic stroke, and significantly reduced the risk of haemorrhagic stroke (p<0.001).1–4 Standard-dose Pradaxa® 150 mg b.d. (n=6,076), meanwhile, significantly reduced the risk of stroke and systemic embolism (p<0.001), haemorrhagic stroke (p<0.0001) and ischaemic stroke (p<0.035) vs warfarin.1–3,5
Pradaxa® risk of major bleeding vs warfarin
The RE-LY trial demonstrated that low-dose Pradaxa® 110 mg b.d. significantly reduced the risk of major bleeding (p=0.003) and intracranial bleeding (p<0.001) vs warfarin, while having a comparable risk of major GI bleeding (p=not significant).1-3 Standard dose Pradaxa® 150 mg b.d. had a comparable risk of major bleeding to warfarin, and was associated with a significantly reduced risk of intracranial bleeding (p<0.001), but a significantly increased risk of major GI bleeding (p=0.001).1-3
Both doses of Pradaxa® significantly reduced the risk of life-threatening bleeding, intracranial bleeding, minor bleeding, and major or minor bleeding vs warfarin (p<0.05).1-3
About the Pradaxa® RE-LY study
RE-LY was a Phase III, prospective, randomised, open-label, blinded endpoint trial which compared Pradaxa® 110 mg and 150 mg b.d. with warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation.1 The trial enrolled 18,113 patients with non-valvular atrial fibrillation with at least one additional risk factor for stroke or systemic embolism who were randomised to receive blinded fixed doses of Pradaxa® 110 mg or 150 mg b.d., or open-label, dose-adjusted warfarin (target INR 2.0-3.0).1 The primary outcome was stroke or systemic embolism and the primary safety outcome was major bleeding. The median duration of follow-up was 2.0 years.1
To learn about patient outcomes with Pradaxa® in a real-world setting,
see the Real-world evidence for Pradaxa®.
ARI — absolute risk increase
ARR — absolute risk reduction
b.d. — twice daily
CI — confidence interval
GI — gastrointestinal
HR — hazard ratio
NOAC — non-vitamin k antagonist oral anticoagulants
ns — not significant
o.d. — once daily
RRI — relative risk increase
RRR — relative risk reduction
- Connolly SJ, et al. N Engl J Med 2009;361:1139–1151.
- Connolly SJ, et al. N Engl J Med 2010;363:1875–1876.
- Connolly SJ, et al. N Engl J Med 2014;371:1464–1465.
- Pradaxa® 110 mg hard capsules Summary of Product Characteristics.
- Pradaxa® 150 mg hard capsules Summary of Product Characteristics.
- Fox KA, et al. Eur Heart J 2011;32(19);2387–2394.
- Granger CB, et al. N Engl J Med 2011;365;981–992.
- Giugliano RP, et al. N Engl J Med 2013;369;2093–2104.