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Arrhythmia Watch Team

Clinical Articles, Lead Article

DABIGATRAN LICENSED IN UK

A new oral anticoagulant, dabigatran etexilate (Pradaxa®, Boehringer Ingelheim), has been made available in the UK. Following the EU licence for dabigatran, granted on 1st August 2011,1 a recommended dose of 150 mg twice daily is now licensed in the UK for the prevention of stroke and systemic embolism in eligible adult patients with AF.

The granting of the licence follows the submission of data from the RE-LY trial – the largest phase III stroke prevention in AF trial published to date involving 18,113 patients enrolled in 951 centres in 44 countries.  The primary endpoint of the trial was incidence of stroke and systemic embolism, its results showing that the recommended dose of dabigatran 150 mg twice daily reduced the relative risk of stroke or systemic embolism by 35% in eligible AF patients compared to warfarin. The primary safety outcome measure in RE-LY, major haemorrhage, was comparable in the dabigatran 150mg twice daily group and the warfarin group.2,3

In the RE-LY study, dabigatran 110 mg, twice daily, demonstrated similar reductions in stroke and systemic embolism compared to warfarin, while delivering a 20% per year reduction (p = 0.003) in major bleeding rates compared to warfarin: the rate of major haemorrhage was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (p = 0.003). 2,3

Like warfarin, dabigatran has been shown to cause bleeding, with a higher risk of gastrointestinal (GI) bleeding and GI symptoms than warfarin but a lower risk of intracranial haemorrhage.3

Professor John Camm, Head of the Department of Cardiac and Vascular Sciences, St. Georges Hospital, London comments, “Atrial fibrillation, is a very common problem affecting about 2% of the population. Often the first time someone finds out they have AF is when they have a stroke, which is a real disaster. About 50% of the patients who suffer from a stroke die from that stroke within the first few days or weeks and 50% of those who survive have some level of disability at six months. A new anticoagulant, like Pradaxa®, is going to be very important for eligible AF patients”.4

References

1 Pradaxa 150 mg hard capsules SPC, August 2011

2 Connolly SJ, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J

Med 2009; 361:1139-51.

3 Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L: Newly identified events in the

RE-LY® trial. N Engl J Med 2010; 363(19): 1875-1876 (November 4th, 2010).

4 Press release, Boehringer Ingelheim. Pradaxa® (dabigatran etexilate), the first new oral anticoagulant for stroke prevention in atrial fibrillation in over 50 years, now licensed for use in the UK.  On file, 2011.

Published on: September 7, 2011

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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