Boehringer Ingelheim leads biggest thromboembolic disease trial
Germany-based Boehringer Ingelheim has launched the biggest thromboembolic disease clinical trial programme ever. The trials under the umbrella name RE-VOLUTION will involve more than 27,000 patients worldwide and investigate Boehringer Ingelheim's novel oral direct thrombin inhibitor, dabigatran etexilate (Rendix) for the prevention and treatment of thromboembolic disease.
Germany-based Boehringer Ingelheim has launched the biggest thromboembolic disease clinical trial programme ever. The trials under the umbrella name RE-VOLUTION will involve more than 27,000 patients worldwide and investigate Boehringer Ingelheim's novel oral direct thrombin inhibitor, dabigatran etexilate (Rendix) 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 hy-pertension, diabetes or heart failure have a five-fold risk of stroke compared with the general population.
Rendix will also be investigated in the prevention of deep vein thrombosis (DVT) after hip or knee re-placement surgery, acute DVT treatment and secon-dary prevention of DVT.
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 enrolment of 15,000 patients from almost 1,000 study centres worldwide. The comparator drug is warfarin and treatment duration will be up to three years.
As Professor Lars Wallentin, one of the co-chairs for 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.'
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.