Pradaxa® (Dabigatran Etexilate) Revolutionizes Stroke Prevention in Atrial Fibrillation

• More than 350,000 patients already taking Pradaxa^® in the U.S., Canada and Japan less than 10 months following approval^1,2,3
• Cardiologists have broadly adopted the breakthrough treatment in the U.S. and nine out of 10 that treat a majority of atrial fibrillation patients have prescribed it (n=14,019)⁴
• First trial (phase II) investigating the benefit of a novel oral anticoagulant in patients with mechanical heart valves to be initiated

INGELHEIM, Germany--(BUSINESS WIRE)--For NON-U.S., UK & Canada Health Media Only

Boehringer Ingelheim today announced that more than 350,000 patients have already been prescribed Pradaxa^® (dabigatran etexilate) for stroke prevention in non-valvular atrial fibrillation (AF) less than 10 months following its approval in the U.S., Canada and Japan.^1,2,3 Latest data show that cardiologists have broadly adopted the breakthrough treatment in the U.S. and nine out of 10 that treat a majority of AF patients have prescribed it (n=14,019).⁴

Dabigatran etexilate was the first novel oral anticoagulant approved^5,-9 for stroke prevention in AF since the current standard of care warfarin was made available 55 years ago. These approvals were based on the landmark RE-LY^® trial, which showed that dabigatran etexilate 150mg bid was significantly superior in reducing the risk of stroke or systemic embolism by an additional 35% compared to well-controlled warfarin^10,11 (median TTR 67%⁵), while at the same time demonstrating significant reductions in intracranial and life threatening bleeds.¹⁰ The RE-LY^® results were demonstrated in the intention-to-treat population, the accepted standard for reporting superiority in clinical trials.¹² The RE-LY^® trial was a PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial designed to compare 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.¹³

The broad uptake of dabigatran etexilate in stroke prevention in AF has been largely consistent across the U.S., Canada & Japan:

• U.S.: Over 250,000 patients have been prescribed dabigatran etexilate¹ – approximately 2.3 million patients are currently treated for AF in the U.S.¹⁴
• Canada: 42,000 patients have been prescribed dabigatran etexilate² where an estimated 250,000 patients are currently treated for AF¹⁵
• Japan: 64,000 patients have been prescribed dabigatran etexilate following its approval in March 2011.³ An estimated 830,000 patients are currently treated for AF in the country.¹⁶

Dr. Stuart Connolly, Director, Division of Cardiology at McMaster University and member of The Population Health Research Institute, Hamilton, Ontario said, “The large number of patients using dabigatran etexilate is great news and not surprising, given that the treatment is a superior and more convenient alternative to warfarin in stroke prevention in AF. The experience that physicians are gaining in using dabigatran etexilate in clinical practice is invaluable, and I hope this is shared and utilized to lead to more patients using this novel treatment worldwide.”

In Canada and the U.S., the majority of physicians consider the performance of dabigatran etexilate to be better than warfarin on all relevant attributes in clinical practice,^17,18 with Canadian physicians preferring the novel treatment mainly due to its superior stroke prevention and the fact that it does not require routine monitoring.¹⁷ In addition, physicians in the U.S. have been using the novel treatment in a broad range of patients, with 30% of prescriptions written for patients over the age of 80.¹⁹

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim said, “We are proud that dabigatran etexilate, a drug from our own research and development, is being used worldwide to help protect patients from the potentially devastating effects of an AF-related stroke. Our commitment in this area is resolute, and with the extensive RE-VOLUTION^® clinical trial programme evaluating the efficacy and safety of dabigatran etexilate in over 40,000 patients in six different potential indications, Boehringer Ingelheim is at the forefront to make new anticoagulant treatment options available to patients.”

Boehringer Ingelheim is now underlining its leadership position with the initiation of the first trial (phase II) investigating the potential benefit of a novel oral anticoagulant in patients with mechanical heart valves. The RE-ALIGN trial (Randomised, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacement) will evaluate the dosages of dabigatran etexilate of 150mg to 300mg bid in a potential future indication, an area of growing medical need and prevalence, given that the number of heart valve implants is expected to triple to 850,000 by 2050 due to the aging population.²⁰

Prof. Frans Van de Werf, Department of Cardiovascular Medicine, University Hospitals Leuven, Belgium said, “The only effective option currently available for patients who undergo mechanical heart valve replacement to prevent valve thrombosis and thromboembolism are vitamin K antagonists, which have many limitations in clinical practice. The RE-ALIGN trial will provide us with important first insights into the potential use of dabigatran etexilate in this area. It is important to note that dosages tested in this study include ones that are significantly higher than those currently approved for use in stroke prevention in AF.”

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2011/26_august_2011_dabigatran.html