The first new oral anticoagulant for the prevention of stroke and systemic embolism will be available in the UK from the 18th August 2011, after the EU license is granted on the 1st August this year. Pradaxa®, is the first new oral anticoagulant in over 50 years licensed for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (AF) and one or more risk factors (please see notes to editors). Its' release is a significant benchmark in treatments of patients affected by AF, the most common heart rhythm condition in the UK and a major cause of stroke.

"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,"


comments Professor John Camm, Head of the Department of Cardiac and Vascular Sciences, St. Georges Hospital, London. He continued,

"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."


The US license to prevent stroke and systemic embolism in eligible adult patients with AF was granted following the submission of data from the RE-LY trial, the largest phase III stroke prevention in AF trial published to date. Research was conducted on 18,113 patients from 951 centers in 44 different countries. The recommended dosage for Pradaxa 150mg is twice daily administration.

The research used incidence of stroke and systemic embolism as primary endpoints of the RE-LY trial and revealed, that the recommended dose of Pradaxa 150mg twice daily reduced the relative risk of stroke or systemic embolism by 35% in eligible AF patients compared to warfarin (1.71% per year with warfarin to 1.11% per year with Pradaxa 150mg, a 0.6% per year absolute reduction in risk {ARR} which is a 35% per year relative risk reduction {RR}; p<0.001). Major haemorrhage, the major safety risk for stroke and systemic embolism patients was comparable in the Pradaxa 150mg group and warfarin group.

Pradaxa 110mg twice daily, (a dose for specific patients - please see notes to editors), revealed similar reductions in stroke and systemic embolism compared to warfarin. Pradaxa 110mg showed a yearly reduction of 20% (p=0.003) in major bleedings compared to warfarin. The yearly rate of major haemorrhage was 3.36% in the warfarin group compared to 2.71% in the 110 mg dabigatran (p= 0.003, ARR of 0.65%) group.

Pradaxa offers doctors new treatment options for the prevention of stroke in AF patients without having to monitor for frequent coagulation, changes in dosage or routine adjustment and dietary restrictions.

Although Pradaxa and warfarin can both cause bleeding, Pradaxa has a higher risk of gastrointestinal bleeding and GI symptoms compared to warfarin but a lower risk of intracranial haemorrhage. Clinical judgment should always be considered in the treatment of individual patients.

1.2 million people in the UK suffer from AF, the most common heart rhythm condition, which is a leading cause of stroke. Stroke belongs to the top three mortality causes of death and is the leading cause of adult disability in England. AF is responsible for an estimated 15% of strokes with an average cost of over 10,000 GBP per patient, which can increase up to a further 7,900 GBP yearly in follow up costs if the stroke is disabling. The overall cost of stroke patients costs the NHS is over 3 billion GBP annually.

Written by Petra Rattue