Why Pradaxa?
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In addition to clinical trials you want the confidence of knowing that the safety and efficacy of Pradaxa had been independently validated and will be reflected when you prescribe Pradaxa in everyday clinical practice.

Results in the real world rarely match those of clinical trials. This is not the case with Pradaxa.

Confidence through real-world experience1–7

When you choose Pradaxa, you can be reassured by the fact that its safety and effectiveness, as seen in RE-LY,8-10 has been re-examined and validated by independent regulatory bodies like the FDA, in more than

An image showing the number of patients treated by Pradaxa (Dabigatran) in the real world

How often does real-world experience match clinical trial data?


In fact, this is relatively rare. However, not with Pradaxa. The safety and efficacy of Pradaxa, as seen in RE-LY,8-10 has been validated by the FDA in one of the largest real-world data analyses of its kind.*1

 

An image showing the number of patients aged 65 years or older

Real-world experience - FDA Medicare study


An image showing adverse event information for Pradaxa (Dabigatran) vs. Warfarin

 

 

*Of the 134,414 patients, 67,207 were taking Pradaxa [16% taking 75 mg BID and 84% taking 150 mg BID.].1 75 mg BID is not licensed in Europe for this indication.11 Outcomes listed apply to 150 mg BID + 75 mg BID combined, as well as to 150 mg BID alone, with the exception of major bleeds and myocardial infarction, where only combined 150 mg BID + 75 mg BID data are available.1 Patients were new users (OAC treatment naïve) of Pradaxa or warfarin.
† Results for Pradaxa 110 mg not shown.
‡ Data is statistically significant.

Should you still be looking for further evidence, two additional independent US real-world studies also reflected the findings of RE-LY.2,3

Real-world experience – US Health Insurance database analysis2


The number of patients involved in the Re-Ly clinical trial with a mean age of 68 years
An image listing information around the rate and risk of adverse events

 

Patients were new users (OAC treatment naïve) of Pradaxa or warfarin. 17.6% of patients were taking Pradaxa 75 mg BID.
§ In the EU, the licensed doses for Pradaxa are 150 mg BID and 110 mg BID for the prevention of stroke and systemic embolism in adult patients with non-valvular AF. In the USA, the licensed doses for Pradaxa are 150 mg BID and 75 mg BID for the prevention of stroke and systemic embolism in adult patients with non-valvular AF. Primary findings for Pradaxa are based on both 75 mg and 150 mg BID together, without stratification by dose.

Real-world experience – US Department of Defense database analysis3


The number of patients involved in the Re-Ly clinical trial with a mean age of 74 years
Information around the rates and risks of adverse events (with risk of mortality included)

 

Patients were new users (OAC treatment naive) of Pradaxa or warfarin.
§In the EU, the licensed doses for Pradaxa are 150 mg BID and 110 mg BID for the prevention of stroke and systemic embolism in adult patients with non-valvular AF. In the USA, the licensed doses for Pradaxa are 150 mg BID and 75 mg BID for the prevention of stroke and systemic embolism in adult patients with non-valvular AF. Primary findings for Pradaxa are based on both 75 mg and 150 mg BID together, without stratification by dose.

These results have not only been confirmed in a US population.

  • Independent Danish Registry studies further supported the safety of Pradaxa, this time in a European real-world population.4,5

The safety of Pradaxa has been more thoroughly scrutinized than any other NOAC.

References: 
  1. Graham DJ et al. Circulation 2015;131(2):157-164.
  2. Seeger JD et al. Presented at AHA 2014.
  3. Villines TC et al. Presented at AHA 2014.
  4. Larsen TB et al. Am J Med 2014;127(7):650-656.
  5. Larsen TB et al. Am J Med 2014;127(4):329-336.
  6. Lauffenburger JC et al. J Am Heart Assoc 2015;4(4):e001798.
  7. Abraham NS et al. BMJ 2015;350:h1857.
  8. Connolly SJ et al. N Engl J Med 2009;361(12):1139–1151.
  9. Connolly SJ et al. N Engl J Med 2010;363(19):1875–1876 (appendix).
  10. Connolly SJ et al. N Engl J Med 2014;371(15):1464–1465.
  11. Pradaxa Summary of Product Characteristics 2016. Boehringer Ingelheim.