Boehringer Ingelheim, of the world's 20 leading pharmaceutical companies, announced new milestones for the novel oral anticoagulant Pradaxa (dabigatran etexilate) with over two million patient-years of experience in all licensed indications globally.

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.

By initiating new research will help to strengthen the understanding of 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.

Professor Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim said, "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." Professor Dugi, further added, "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. 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 surgery; acute treatment of deep vein thrombosis (DVT) or primary embolism (PE); prevention of recurrent DVT or PE8.

The company also announced that it had submitted applications to US and EU regulatory authorities to review Pradaxa for use in patients with DVT and PE.

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.

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 Programme 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 Programme 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.

Pradaxa is approved in over 100 countries worldwide. It is licensed for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of venous thromboembolism in patients undergoing total hip replacement or total knee replacement surgery.

Pradaxa, a direct thrombin inhibitor (DTI), was the first of a new generation of direct oral anticoagulants targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.

Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.

The Boehringer Ingelheim group is committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.