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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

Choosing a low-dose NOAC for stroke prevention in NVAF: a closer look at the dosing criteria

Choosing a NOAC for the prevention of stroke and systemic embolism in your patients with non-valvular atrial fibrillation (NVAF) is an important choice, but with four different NOACs available, each with different dose reduction criteria, it can be a challenge to select the most appropriate option for each patient.1-8 For patients who are at an increased risk of bleeding, it can be tempting to prescribe a reduced NOAC dose, but this can lead to under-dosing and impact patient outcomes.9

 

While each of the available NOACs have clearly defined dose-reduction criteria, Pradaxa® (dabigatran etexilate) offers the flexibility to prescribe the reduced Pradaxa® 110mg b.d. dose for your patients who you are worried are at increased risk of bleeding.1,2*

*Examples of increased bleeding risk may include: the patient is 75-80 years old; suffering from gastritis, oesphagitis or gastroesophageal reflux; has moderate renal impairment (CrCL 30-50mL/min). For further details of factors which may increase bleeding risk please refer to the Summary of Product Characteristics. Pradaxa® is contraindicated in patients with severe renal impairment (CrCL <30 mL/min).1,2

Choosing a low-dose NOAC:
a closer look at the
dosing criteria

Low Dose NOAC
Low Dose NOAC
Adverse patient outcomes
Adverse patient outcomes
Hospitalisation
Hospitalisation
All-cause mortality
All-cause mortality

NOAC under-dosing has been associated with increased risk of stroke/systemic embolism, hospitalisation, and deaths without appreciable reduction in major bleeding.10,11

Low Dose NOAC
Low Dose NOAC

Despite the criteria available, under-dosing of NOACs is a significant problem. In a cross-sectional study of UK primary care, under-dosing was more than twice as common among patients starting on apixaban than those starting on Pradaxa® or rivaroxaban.9

Dose reduction for consideration for Pradaxa® included patients aged 75-80 years old, patients with moderate renal impairment (CrCL 30-50 mL/min) and patients with gastritis, oesophagitis or gastroesophageal reflux, but did not take into account that Pradaxa® can be dose-reduced in other patients the physician considers to be at risk of bleeding. Therefore these patients may not have been inappropriately dose reduced.

Low Dose NOAC

There are significant differences in the dosing requirements of low-dose NOACs:1-8

Low Dose NOAC
  • Low-dose NOACs are an effective first-line treatment choice for eligible patients with atrial fibrillation with certain clinical features such as patients with an increased risk of bleeding1-8,12
  • Pradaxa® is the only NOAC that gives the physician the flexibility to select the appropriate dose for an individual patient based on their assessment of the patient's thromboembolic risk and risk of bleeding1,2

aPradaxa® is contraindicated in patients with severe renal impairment
(CrCL <30 mL/min).1,2

bApixaban is not recommended in patients with CrCL <15 mL/min.3,4

cEdoxaban is not recommended in patients with CrCL <15 mL/min.5,6

dRivaroxaban is not recommended in patients with a CrCL <15 mL/min and should be used with caution in patients with CrCL 15–29 mL/min.7,8

*Examples of increased bleeding risk may include: the patient is 75-80 years old; suffering from gastritis, oesophagitis or gastroesophageal reflux; has moderate renal impairment (CrCL 30-50mL/min). For further details of factors which may increase the bleeding risk please refer to the Pradaxa® Summary of Product Characteristics.

Abbreviations

b.d. — twice daily

CrCL — creatinine clearance

NOAC — non-vitamin K antagonist oral anticoagulant

NVAF — non-valvular atrial fibrillation

o.d. — once daily

P-gp — P-glycoprotein

References
  1. Pradaxa® 150mg hard capsules Summary of Product Characteristics.
  2. Pradaxa® 110mg hard capsules Summary of Product Characteristics.
  3. Eliquis® 5mg film-coated tablets Summary of Product Characteristics.
  4. Eliquis® 2.5mg film-coated tablets Summary of Product Characteristics.
  5. Lixiana® 30mg film-coated tablets Summary of Product Characteristics.
  6. Lixiana® 60mg film-coated tablets Summary of Product Characteristics.
  7. Xarelto® 20mg film-coated tablets Summary of Product Characteristics.
  8. Xarelto® 15mg film-coated tablets Summary of Product Characteristics.
  9. Garcia Rodriguez LA, et al. BMJ Open 2019;9:e031341.
  10. Steinberg BA, et al. J Am Coll Cardiol 2016;68:2597-2604.
  11. Hindricks G, et al. Eur Heart J 2020; doi:10.1093/eurheartj/ehaa612.
  12. Steffel J, et al. Eur Heart J 2018;39:1330-1393.
PC-GB-101393 V1 | December 2020

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