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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

Real-world evidence for the
safety and efficacy of Pradaxa® (dabigatran etexilate)

The safety and efficacy of Pradaxa® (dabigatran etexilate) for stroke prevention in non-valvular atrial fibrillation (NVAF) demonstrated in randomised controlled trials (RCTs) is supported by independent real-world studies involving over 675,000 patients with NVAF receiving Pradaxa® for stroke prevention.1

Low dose Pradaxa® (110 mg b.d.)
in a real-world setting

 A nationwide Danish cohort study comparing low-dose non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin2

Independent real-world evidence from an observational, nationwide cohort study of 55,644 anticoagulant-naive Danish patients with NVAF who filled a prescription for a reduced-dose NOAC (Pradaxa® 110 mg b.d., apixaban 2.5 mg b.d., rivaroxaban 15 mg o.d.) or warfarin for stroke prevention demonstrated:

  • Similar rates of ischaemic stroke or systemic embolism for Pradaxa® 110 mg b.d. vs warfarin
     
  • Significantly lower rates of any bleeding with Pradaxa® 110 mg b.d. vs warfarin
     
  • The mortality risk was similar for Pradaxa 110 mg b.d. vs warfarin, but appeared to be higher for other low-dose NOACs vs warfarin
Weighted event rate any bleeding events according to initiated treatment
Weighted event rate any bleeding events according to initiated treatment2*

Standard dose Pradaxa®️ (150 mg b.d.)
in a real-world setting

Retrospective, new-user US cohort study comparing standard dose NOACs with warfarin and each other3

Independent real world evidence from a retrospective, new-user cohort study of 448,944 US Medicare patients with NVAF aged 65 years or older who initiated standard doses of Pradaxa® (150 mg b.d.), rivaroxaban (20 mg o.d.), apixaban (5 mg b.d.) or warfarin for stroke prevention was conducted by the FDA and demonstrated:

  • Outcomes for Pradaxa® 150 mg b.d. were consistent with those reported in the RE-LY clinical trial
     
  • A significant reduction in risk of thromboembolic stroke, intracranial haemorrhage and all-cause mortality with Pradaxa® 150 mg b.d. vs warfarin
     
  • Rivaroxaban 20 mg o.d. was associated with a significantly increased risk of intracranial haemorrhage, major extracranial bleeding (includes major gastrointestinal bleeding) and death vs Pradaxa® 150 mg b.d.
     
  • Pradaxa® 150 mg b.d. demonstrated a significantly lower risk of intracranial haemorrhage vs apixaban 5 mg b.d. with a significantly increased risk of major extracranial bleeding (includes major gastrointestinal bleeding).
     
  • No difference in risk of thromboembolic stroke or death with apixaban 5 mg b.d. vs Pradaxa® 150 mg b.d.
Adjusted incidence rates per 1000 person-years of thromboembolic stroke
Adjusted incidence rates per 1000 person-years of thromboemboli
Abbreviations

b.d. — twice daily

CI — confidence interval

FDA — Food and Drug Administration

HR — hazard ratio 

NOAC — non-vitamin k antagonist oral anticoagulants

NVAF — non-valvular atrial fibrillation

o.d. — once daily

RCT — randomised controlled trial

References
  1. Boehringer Ingelheim Data on File: DBG 19–03.
  2. Nielsen PB, et al. BMJ 2017;356:j510.
  3. Graham DJ, et al. Am J Med 2019;132(5):596–604.e11.
PC-GB-101421 V1 | August 2020

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