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
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.
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
- Boehringer Ingelheim Data on File: DBG 19–03.
- Nielsen PB, et al. BMJ 2017;356:j510.
- Graham DJ, et al. Am J Med 2019;132(5):596–604.e11.