MUNICH - Monday, August 27th 2012 [ME NewsWire]
40,000 people estimated to be saved from a stroke related to non-valvular atrial fibrillation
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Boehringer Ingelheim has announced today that the combined treatment experience with Pradaxa® has crossed one million patient-years1 in the prevention of thromboembolic events in patients after surgery and in patients with non-valvular atrial fibrillation (AF), providing the greatest body of clinical experience among all novel oral anticoagulants. The announcement, made during the European Society of Cardiology (ESC) Congress 2012 in Munich, Germany, reaffirms the confidence physicians have in Pradaxa® to effectively prevent stroke and systemic embolism in patients with non-valvular AF and venous thromboembolic events following hip or knee replacement surgery.
One million patient-years of treatment experience is unprecedented for a novel oral anticoagulant and highlights a broad adoption of Pradaxa® in more than 70 countries worldwide following regulatory approvals in stroke prevention in AF. This level of clinical use shows strong endorsement for the substantial benefits Pradaxa® has demonstrated in the RE-LY® trial,*2,3 and for its positive benefit-risk profile, as recently reconfirmed by the European Medicines Agency.4
“It is great to see this treatment being accepted and adopted all over the world for the benefit of patients being effectively protected against thromboembolic events,” commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “One million patient years is an important milestone, but even more important is how many strokes our treatment already is likely to have prevented, protecting patients and their families from the impact of this devastating event.”
The benefit of Pradaxa® in stroke prevention in patients with non-valvular AF compared to no treatment can be derived from the reduction in the risk of stroke observed in the pivotal clinical RE-LY® study2,3 and by comparing against historical trials in AF patients receiving no treatment.5,6 Taking into account the overall real-world exposure achieved since the first approval of Pradaxa® in this indication, it can be calculated that Pradaxa® may have already prevented up to 40,000 strokes in non-valvular AF patients, compared to no treatment.1-3,5,6
Commenting on the news, Professor Hans-Christoph Diener, Department of Neurology, University of Duisburg-Essen, Germany said, “Preventing ischaemic stroke is of utmost clinical importance for healthcare professionals treating patients with AF. With dabigatran 150mg bid, clinicians have a treatment available that prevents more ischaemic strokes than well controlled warfarin and reduces intracranial haemorrhage at the same time. The estimated number of strokes prevented shows the relevance of dabigatran as a safe and efficacious preventive treatment for patients with AF at risk of stroke.”
Pradaxa® 150mg bid is the only novel oral anticoagulant, study of which has shown a significant reduction of ischaemic strokes in patients with non-valvular AF compared to warfarin, offering a relative risk reduction of 25%.2,3 In RE-LY®, a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), Pradaxa® 150mg bid provided a 35% reduction in the overall risk of stroke and systemic embolism versus well-controlled warfarin (INR 2-3, median TTR 67%7).2,3 Pradaxa® 110mg bid, which is indicated for certain patients, was shown to be non-inferior compared to well-controlled warfarin for the prevention of stroke and systemic embolism.2,3 Both doses of Pradaxa® were associated with significantly lower total, intracranial and life-threatening bleeding compared to well-controlled warfarin, and Pradaxa® 110mg bid additionally demonstrated significantly lower major bleeding versus warfarin.2,3
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/27_august_2012_dabigatranetexilate.html
*RE-LY® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.2,3
Contacts
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Julia Meyer-Kleinmann
Phone: +49 6132 77 8271
Fax: +49 6132 77 6601
E-mail: press@boehringer-ingelheim.com
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