The trials under the umbrella name RE-VOLUTION and involving more than 27,000 patients worldwide, will investigate a novel oral direct thrombin inhibitor, dabigatran etexilate, researched and developed by the Germany-based pharmaceutical company to prevent and treat thromboembolic disease.
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.
The target indications include stroke prevention in atrial fibrillation (SPAF). Atrial fibrillation is the most common form of cardiac arrhythmia and accounts for 15 percent 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.
Dabigatran will also be investigated for 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 phase III study of stroke prevention in atrial fibrillation, called RE-LY under the umbrella of the RE-VOLUTION trial, has recruited the first patients of a planned total patient enrolment of 15,000 from almost 1,000 study centers worldwide.
The Philippines is part of RE-LY study to be conducted by Filipino cardiologists and neurologists in major hospitals in Metro Manila.
In this study, dabigatran will be compared with the drug warfarin for a treatment duration of up to three years.
The therapeutic options for prevention of thromboembolic diseases are limited at the moment. Most anticoagulants are only available as injectables, which limit 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 affects quality of life due to many interactions with food and other drugs.
In a survey, cardiologists, hematologists, neurologists and general practitioners called 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.
Dr. Andreas Barner, Boehringer Ingelheim board member and research, development and medicine head worldwide, said, "We are confident that dabigatran will fulfill the medical need for a wide range of patients who have atrial fibrillation and are therefore 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: dipyridamole/aspirin combination and alteplase (recombinant human tissue plasminogen factor), and the RE-LY study will give us additional scientific insights," Barner added.
Prof. Lars Wallentin, one of the co-chairmen of the worldwide 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."