DUBAI, United Arab Emirates - Friday, April 20th 2012 [ME NewsWire]
For Non-US, Non-UK & Non-Canadian Media Only
(BUSINESS WIRE)-- Boehringer Ingelheim announced today the launch of the GLORIATM-AF Registry Program, which is set to become the largest worldwide registry with the aim of understanding the long-term use of oral antithrombotic therapy in the prevention of non-valvular atrial fibrillation (AF)-related stroke in a real-world setting.
With up to 56,000 patients planned for enrolment across 2,200 sites in 50 countries, GLORIATM-AF will study treatment regimes available for stroke prevention in non-valvular AF and respective patient outcomes. The Registry Program will collect important data on the safety and comparative effectiveness of antithrombotic treatments, including vitamin K antagonist (VKA) warfarin, acetylsalicylic acid (ASA) and novel oral anticoagulants, such as dabigatran etexilate (Pradaxa®).
“With novel oral anticoagulants entering the market having shown convincing clinical trial data in the prevention of stroke in non-valvular AF, registries such as GLORIATM-AF are important in investigating how these trial results translate into clinical practice, and provide insight into how antithrombotic therapy can be fully optimised to ensure patients with AF at risk of stroke receive the best possible care,” says Dr. Menno Huisman, Associate Professor at Leiden University Medical Center, Department of Thrombosis and Haemostasis, Netherlands and Chair of the GLORIATM-AF Registry Program.
To mirror the real-world setting, GLORIATM-AF will involve a range of clinical settings including general practices, specialist offices, community hospitals, university hospitals, outpatient care centres and anticoagulation clinics. By 2012, the registry will have started in countries of all major regions of the world, including USA, EU, Latin America and Asia with other participating countries following subsequently and completion anticipated by 2020.
“The launch of the GLORIATM-AF Registry Program is exciting news and a really important step forward,” says Eve Knight Co-Founder and Chief Executive of AntiCoagulation Europe (ACE), UK. “Given that AF is the most common sustained heart rhythm condition affecting over 70 million people worldwide and is associated with raising the risk of someone with AF having a stroke by five times, it is incredibly important to find out how effective and safe both old and new treatments are in protecting people from a potentially disabling and deadly stroke.”
VKA therapy has been the long-time standard of care for stroke prevention in AF. While VKA therapy is very effective in reducing the risk of stroke in patients with non-valvular AF,1 there are significant challenges associated with its use, including regular monitoring, dosing adjustment and numerous drug–drug and drug–food interactions. Due to these limitations,1 only half of eligible patients (51%) receive treatment with VKA therapy2 and fewer than half of these patients are controlled within the desired therapeutic range, leading to a significant unmet need in stroke prevention in AF.3
To address the shortcomings of VKAs, several novel oral anticoagulants have been studied in late stage clinical development including factor Xa inhibitors and the direct thrombin inhibitor Pradaxa®4 In the landmark RE-LY® trial, Pradaxa® 150mg bid compared to well-controlled warfarin (median time in therapeutic range (TTR) 67%5), was shown to be the first novel oral anticoagulant superior to well-controlled warfarin for the prevention of ischaemic and haemorrhagic stroke and systemic embolism for adult patients with non-valvular AF at risk of stroke.6,7 Pradaxa® 110mg bid, which is indicated for certain patients with non-valvular AF, was shown to be non-inferior to well-controlled warfarin for the prevention of stroke and systemic embolism.6,7 To date, Pradaxa® has been approved for the prevention of stroke in non-valvular AF in more than 70 countries worldwide.
Gregory Lip, Professor of cardiovascular medicine at University of Birmingham Centre for Cardiovascular Sciences, UK said, “GLORIATM-AF is a truly collaborative effort, which brings together leading experts from a number of therapy areas across the globe to gain insights into the changing landscape of stroke prevention in non-valvular AF. It is with excitement that we are anticipating presenting more details about the unique design of this Registry Program later in 2012.”
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/20_april_2012_dabigatranetexilate.html
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