"We are proud that Pradaxa® has been awarded the Canadian Prix Galien," says Prof. Dr. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "The decision by the jury underlines the outstanding innovation Pradaxa® brings for patients and doctors, providing a much needed advance in stroke prevention in atrial fibrillation, an area of high therapeutic need."
The approval of Pradaxa® in prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (SPAF) was based on data from the landmark RE-LY® trial (Randomized Evaluation of Long term anticoagulant therapY), a global, Phase III trial of 18,113 patients, enrolled in over 950 centres in 44 countries. 1 Compared to well-controlled warfarin (median time in therapeutic range (TTR) 67.3%2), the following results were seen with Pradaxa® in the landmark RE-LY® trial:(1,2,3)
- Pradaxa® 150mg bid significantly reduced the risk of stroke and systemic embolism by 35%, providing clinically important stroke prevention in non-valvular atrial fibrillation (AF)
- Pradaxa® 150mg bid significantly reduced both ischaemic (RRR 25%) and haemorrhagic stroke (RRR 74%)
- Pradaxa® 110mg bid (indicated for certain patients) showed similar rates of stroke and systemic embolism as well-controlled warfarin
- Both doses of Pradaxa® significantly reduced intracranial and life threatening bleeding compared to warfarin
- Pradaxa® 110mg bid also significantly reduced major bleeds.
The RE-LY® trial was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.(1)
"Pradaxa is a significant advance in medicine. We have been waiting a long time for an alternative to warfarin. Pradaxa provides superior and clinically significant stroke prevention in the high dose while maintaining an equal level of safety when compared to warfarin," says Dr. Stuart Connolly, Director, Division of Cardiology at The Population Health Research Institute, McMaster University in Hamilton, Canada. "In addition, it does not require regular blood tests, constant dose adjustments or food restrictions, which makes it very convenient for patients."
Pradaxa® is an oral anticoagulant for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (SPAF) and the primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery. The approval of Pradaxa® was welcomed by the medical community and patients because it was the first new oral anticoagulant approved in decades in countries all over the world.
AF is the most common type of arrhythmia or irregular heartbeat, affecting around 1% of the total population with one in four adults over 40 developing the condition in their lifetime.(4,5) People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold.(5,6) Up to three million people worldwide suffer strokes related to AF each year.(7,8,9)
About dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs) (10) 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.
RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial of 18,113 patients enrolled in over 900 centres in 44 countries designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran (110mg and 150mg bid) each administered in a blinded manner, with well controlled (INR 2.0-3.0, median TTR 67% 2) open label warfarin.(1,3) Patients were followed-up in the study for a median of 2 years with a minimum of 1 year follow-up.(1,3)
The primary endpoint of the trial was incidence of stroke (including haemorrhagic) or systemic embolism. Secondary outcome measures included all-cause death, incidence of stroke (including haemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).
About Boehringer Ingelheim
The Boehringer Ingelheim group of companies is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavours.
In 2010, Boehringer Ingelheim posted net sales of 12,6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.
1. Connolly SJ, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-51.
2. Pradaxa®, Summary of Product Characteristics, August 2011. Europe.
3. Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med 2010; 363(19):1875-6.
4. Stewart S, et al. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart 2004; 90:286-92.
5. Lloyd-Jones DM, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004; 110:1042-6.
6. Fuster V, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation – executive summary. Circulation 2006; 114:700-52.
7. Kannel WB, et al. Final Draft Status of the Epidemiology of Atrial Fibrillation. Med Clin North Am. 2008; 92(1):17–40.
8. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed Dec 2010 at www.who.int/cardiovascular_diseases/en/ cvd_atlas_15_burden_stroke.pdf.
9. Wolf PA, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991; 22(8):983-8.
10. Di Nisio M, et al. Direct Thrombin Inhibitors. N Engl J Med 2005; 353:1028-40.