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Published on 26 August 2011

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Pradaxa® impacts AF stroke prevention

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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 after its approval in the US, Canada and Japan.

The encouraging data suggest that the new oral anticoagulant, which is awaiting approval by the European Medicines Agency, is likely to soon be recommended by Europe.

Latest data from the US show that cardiologists have broadly adopted the breakthrough treatment and nine out of 10 prescribe the treatment to the majority of their AF patients (n=14,019).

Dabigatran etexilate was the first novel oral anticoagulant approved 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 (median TTR 67%), while at the same time demonstrating significant reductions in intracranial and life-threatening bleeds.

The RE-LY® results were demonstrated in the intention-to-treat population, the accepted standard for reporting superiority in clinical trials.

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.

“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,” said Dr Stuart Connolly, Director of the Division of Cardiology at McMaster University, USA.

“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.”

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.

Professor Frans Van de Werf from the Department of Cardiovascular Medicine at University Hospital in 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.”

Boehringer Ingelheim



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