Most Extensive Thromboembolic Disease Clinical Trial Program Launched By Boehringer Ingelheim

Main Category: Vascular
Article Date: 30 Jan 2006 - 7:00 PDT

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Boehringer Ingelheim announced today the launch of the biggest thromboembolic disease clinical trial program ever. The trials under the umbrella name RE-VOLUTIONTM will involve in total more than 27,000 patients worldwide and investigate a novel oral direct thrombin inhibitor, dabigatran etexilate (RENDIXTM) from Boehringer Ingelheim`s Research and Development for the prevention and treatment of thromboembolic disease. The target indications include stroke prevention in atrial fibrillation (SPAF). Atrial fibrillation is the most common form of cardiac arrhythmia and accounts for 15% of all strokes. Patients with atrial fibrillation and one or more additional common risk factors like hypertension, diabetes or heart failure have a five-fold higher risk of stroke compared to the general population.

RENDIXTM will also be investigated in the prevention of deep vein thrombosis (DVT) after hip or knee replacement surgery, acute DVT treatment and secondary prevention of DVT. Venous thromboembolism is a common and potentially life-threatening disease. It is estimated that one fifth of patients who develop deep vein thrombosis die of sudden death due to pulmonary embolism.

The RE-LYTM study of stroke in atrial fibrillation

The phase III - study of stroke prevention in atrial fibrillation, called RE-LYTM under the umbrella of the so-called RE-VOLUTION trial, now recruited the first patients of a planned total enrolment of 15,000 patients from almost 1000 study centres worldwide. The comparator drug is warfarin and treatment duration will be up to three years.

"We are confident that RENDIXTM will fulfil the medical need for a wide range of patients who have atrial fibrillation and are therefor at a high risk of stroke. The prevention of stroke has a high priority especially in aging societies. Boehringer Ingelheim has a lot of experience in this area with our established products for prevention or emergency treatment of stroke, Aggrenox� and Actilyse�, and the RE-LYTM study will give us additional scientific insights.", said Dr. Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine worldwide. As Prof. Lars Wallentin, one of the Co-chairs for the world-wide RE-LY trial, from Uppsala University in Sweden said: "With this trial we are very much looking forward to fully understand the potential of dabigatran so that physicians will be able to offer an effective and safe treatment regimen to prevent their patients from life-threatening events such as stroke with all if not lethal but disabling consequences."

Unmet medical need

The therapeutic options for prevention of thromboembolic diseases are at the moment limited. Most anticoagulants are only available as injectables which limits their use in long-term treatment. The most commonly used oral product is warfarin which has been on the market for more than 50 years. Warfarin requires time consuming and costly monitoring and significantly impacts quality of life due to many interactions with food and other drugs. In a survey done with cardiologists, hematologists, neurologists and general practitioners, they voiced the need for a new oral anticoagulant therapy without coagulation monitoring that is suitable for long-term use and provides a predictable and reliable protection for patients at risk of thromboembolic events, with a low risk of bleeding. RENDIXTM is expected to meet these requirements and has been successfully investigated in thromboembolic diseases in several phase II clinical trials involving more than 2,500 patients. It is the most advanced new oral anticoagulant in clinical development.

Further studies of the RE-VOLUTIONTM program

RE-MODELTM, a trial to study thromboembolism prevention after knee surgery in 2,000 patients is already in the middle of patient recruitment in the European Union, South Africa and Australia. RE-MOBILIZETM is investigating the efficacy and safety of dabigatran etexilate (RENDIXTM) in the same patient group in North America. RE-NOVATETM will enrol app. 3,300 patients after hip surgery in the European Union, in South Africa and Australia. Additional studies with dabigatran etexilate (RENDIXTM) for the treatment and secondary prevention of venous thromboembolism will start early this year.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the privately-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro while spending nearly one fifth of net sales in its largest business segment Prescription Medicines on research and development.

About RENDIXTM (dabigatran etexilate)

Dabigatran etexilate is a promising new oral direct thrombin inhibitor that specifically and reversibly inhibits thrombin, the key enzyme for blood clot formation. It is administered orally in a fixed dose and has a rapid onset of action, providing a consistent anticoagulation effect without the need for coagulation monitoring and dose adjustment.

About RE-VOLUTIONTM

RE-VOLUTION is a multi-center, randomized global outcome trial program initiated by Boehringer Ingelheim in thromboembolic diseases investigating the novel oral direct thrombin inhibitor dabigatran etexilate (RENDIXTM). The trials will involve more than 27,000 patients from Asia, Australia, Europe, the Americas, and South Africa. Currently seven trials are conducted under this umbrella.

RE-NOVATE, RE-MODEL and RE-MOBILIZE are investigating the potential of dabigtran etexilate (RENDIXTM) in the primary prevention of venous thromboembolism after major orthopedic surgery. Studies for the treatment and secondary prevention of venous thromboembolism are RE-SOLVE, RE-COVER and RE-MEDY. RE-LY, which started in December 05, is the study of stroke prevention in atrial fibrillation.

Patients will be divided into different treatment arms involving dabigatran etexilate (RENDIXTM) compared with warfarin or enoxaparin. Patient enrolment for RE-LY, RE-MODEL, RE-NOVATE and RE-MOBILIZE is ongoing. Results are expected from 2006 onwards.

http://www.boehringer-ingelheim.com