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Information for:

UK & IRELAND HEALTHCARE PROFESSIONALS

Click here if you are a healthcare professional and would like more information on Pradaxa® (dabigatran etexilate)


Information intended for:

PATIENTS PRESCRIBED PRADAXA®/ MEMBERS OF THE PUBLIC IN THE UK & IRELAND

Click here for more information on Pradaxa®


PC-GB -101423 V1 August 2020

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®: summary of efficacy and safety outcomes vs warfarin in RE-LY study
Pradaxa®: summary of efficacy and safety outcomes vs warfarin in the RE-LY study1-5

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® (dabigatran) prevention of stroke and systemic embolism vs warfarin
RE-LY study primary efficacy outcome

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

Pradaxa® (dabigatran etexilate) risk of major bleeding vs warfarin
RE-LY study primary safety outcome

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®.

Abbreviations

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

References
  1. Connolly SJ, et al. N Engl J Med 2009;361:1139–1151.
  2. Connolly SJ, et al. N Engl J Med 2010;363:1875–1876.
  3. Connolly SJ, et al. N Engl J Med 2014;371:1464–1465.
  4. Pradaxa® 110 mg hard capsules Summary of Product Characteristics.
  5. Pradaxa® 150 mg hard capsules Summary of Product Characteristics.
  6. Fox KA, et al. Eur Heart J 2011;32(19);2387–2394.
  7. Granger CB, et al. N Engl J Med 2011;365;981–992.
  8. Giugliano RP, et al. N Engl J Med 2013;369;2093–2104.
PC-GB-101420 V1 | August 2020

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