INGELHEIM, Germany--(BUSINESS WIRE)--
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Boehringer Ingelheim today announces new milestones for the novel oral anticoagulant Pradaxa® (dabigatran etexilate) with over two million patient-years of experience in all licensed indications globally.1 In addition, the company confirms research currently underway for Pradaxa® in new cardiovascular patient populations, as well as robust plans to gather real-world evidence in patients with non-valvular atrial fibrillation (NVAF). These plans are the cornerstone of an initiative to expand the scientific knowledge of stroke prevention and interventional cardiology with Pradaxa®, and demonstrate Boehringer Ingelheim’s leadership and commitment to innovative solutions for patients and healthcare providers.
Initiating new research will help strengthen understanding of the safety and efficacy profile of Pradaxa®, the longest studied novel oral anticoagulant (NOAC). Since its discovery 20 years ago, Pradaxa® has been evaluated through the extensive RE-VOLUTION® clinical trial programme, which includes 10 clinical trials involving more than 40,000 patients in over 100 countries globally.2-12
“We are building upon Pradaxa®’s strong foundation in clinical research and prescribing experience to deepen our understanding of the treatment’s benefit/risk profile to address evolving patient needs and benefit the cardiovascular community as a whole,” commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Now, we are in discussions regarding plans for important new clinical trials where we see unmet patient need. Details of these plans will be announced in the near future.”
The efficacy and safety of Pradaxa® to reduce risk of stroke and systemic embolism in patients with NVAF was established in the pivotal RE-LY® trial, one of the largest stroke prevention clinical studies ever conducted with NVAF patients.9,10 To date, Pradaxa® has also been studied in the following areas:
- Prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery2-5
- Acute treatment of deep vein thrombosis (DVT) or primary embolism (PE)6,7
- Prevention of recurrent DVT or PE8
The company recently announced it had submitted applications to U.S. and EU regulatory authorities to review Pradaxa® for use in patients with DVT and PE.
Current Pradaxa® Research Underway
Currently, there are 12 Boehringer Ingelheim-sponsored trials of Pradaxa® in progress. These include studies which investigate Pradaxa® in patients with impaired renal function, as well as paediatric patients, and studies which explore management strategies for gastrointestinal symptoms. An investigational antidote is progressing through phase I clinical research for the reversal of Pradaxa®-induced anticoagulation.13
Additionally, the company is collecting important data on the use of Pradaxa® in clinical practice with ongoing long-term study programmes and registries. The GLORIATM-AF Registry Program is set to become one of the largest worldwide registries with the objective of understanding the long-term use of oral antithrombotic therapies in the prevention of non-valvular AF-related strokes in a real-world setting. Currently, the GLORIATM-AF Registry Program is actively recruiting in 35 countries, with a planned enrolment of up to 56,000 patients worldwide. In addition, Boehringer Ingelheim is working in close collaboration with leading hospitals, insurance, healthcare research and governmental organisations in the USA to further assess the real-world clinical usage of Pradaxa®.
Current Experience with Pradaxa®
Globally, Pradaxa® is currently approved in over 100 countries for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and primary prevention of VTE following total hip replacement or total knee replacement surgery.1,14 The extensive in-market experience of over 2 million patient-years puts Pradaxa® first among the novel oral anticoagulants.1 Since its approval in NVAF, Pradaxa® is estimated to have prevented up to 93,000 strokes in NVAF patients compared to no treatment.1 Combined experience from the clinical trials programme and real-world clinical practice establish Pradaxa® as the longest and most extensively studied novel oral anticoagulant.1
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