Value through Innovation20 September 2014
06 November 2012

Safety and efficacy of Pradaxa® (dabigatran etexilate) reconfirmed in clinical setting for VTE prevention after total knee or hip replacement

For Non-US, Non-UK & Non-Canadian Media Only

  • Results from real-world practice support evidence from clinical trials
  • Pradaxa® is well tolerated with a good safety profile in routine clinical setting
  • Benefit of Pradaxa® seen in all patients regardless of risk of bleeding and/or VTE

Ingelheim, Germany, 6 November, 2012 – New real-world data reinforces the positive safety and efficacy profile of Pradaxa® (dabigatran etexilate) in clinical practice for the prevention of venous thromboembolism (VTE) in patients undergoing total knee or hip replacement.* Data presented today at the 2012 American Heart Association Scientific Sessions highlight that treatment with Pradaxa® was well tolerated and resulted in low incidence of major bleeding events irrespective of patient risk factors.1

VTE has been estimated to be the third most common cardiovascular disorder after coronary heart disease and stroke2. In Europe alone, it affects 1.5 million people and is responsible for 500.000 deaths annually.3,4 Anticoagulation therapy is effective in preventing VTE for patients undergoing total knee or total hip replacement and provides a three-fold reduction in the recurrence of VTE.5 In previous clinical trials, Pradaxa® was proven to be as effective as enoxaparin in this indication with a favourable safety profile and easier administration.6-8

The international observational study aimed to evaluate the safety and efficacy of dabigatran etexilate in a real-world clinical setting. The study involved 5,292 patients, 40 percent of whom had more than one potential risk factor for increased bleeding and/or VTE. The results show:1

  • Very low overall incidence of major bleeding events with Pradaxa®: 0.72% (95% CI 0.51%, 0.98%)
  • Major extra-surgical site bleeding occurred in 0.32% (95% CI 0.19%, 0.51%) of patients
  • Incidence of any bleeding event of 3.82% (95% CI 3.32%, 4.37%)
  • Incidence of the combined endpoint of sVTE and all-cause mortality of 1.04% (95% CI 0.78%, 1.35%)

The low incidence of bleeding seen with Pradaxa® was consistent regardless of potential risk factors, such as chronic heart failure, history of VTE, chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), active smoking, concomitant ASA use, and coronary artery disease.

"These findings are very reassuring for both patients and physicians," said trial investigator Professor Simon Frostick, Institute of Translational Medicine, Faculty of Health & Life Sciences, University of Liverpool, United Kingdom. "They validate the strong safety and efficacy profile of Pradaxa® in this clinical setting, and support the results previously seen in clinical trials. These findings also demonstrate that Pradaxa® is a safe treatment option for VTE prevention in a broad range of patients, even for those at increased risk of bleeding or with a history of VTE."

Clinical experience with Pradaxa® is already well established and continues to grow. It equates to over one million patient-years in over 70 countries worldwide9, including both VTE prevention in patients undergoing total knee or total hip replacement and stroke prevention in patients with non-valvular atrial fibrillation, supporting the substantial benefits Pradaxa® offers to patients for both indications.

NOTES TO THE EDITORS

About venous thromboembolism
Venous thromboembolism (VTE) refers to a condition in which a blood clot (thrombus) forms in a vein. Most commonly, it develops in the deep veins of the leg or pelvis and is known as deep vein thrombosis (DVT). An embolism occurs if the clot, or a part of it, breaks off from the site where it forms and travels through the venous system. If the clot lodges in the lung a potentially fatal condition, pulmonary embolism (PE), occurs.

VTE is the third most common cardiovascular disorder after coronary heart disease and stroke,2 affecting approximately 1.5 million Europeans3 and 3 million Americans10 each year. In Europe, it kills more than twice as many people as AIDS, breast cancer, prostate cancer, and traffic accidents combined.4 In addition, up to half of people suffering from a DVT may develop the chronic post thrombotic syndrome (PTS) and 4% may develop chronic thromboembolic pulmonary hypertension.11,12

Given its prevalence, associated morbidity, mortality and chronic complications, VTE is a costly condition which puts a significant burden on healthcare systems and individuals. Annual costs of VTE are estimated to be more than $1.5 billion in the US alone.13

About dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs)14 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.

About the dabigatran etexilate clinical trial programme
Boehringer Ingelheim’s clinical trial programme to evaluate the efficacy and safety of dabigatran etexilate encompasses studies in:

  • Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery
  • Treatment of acute VTE
  • Secondary prevention of VTE
  • Stroke prevention in AF
  • Prevention of thromboembolism after heart valve replacement.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications 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 endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA, UK or Canada.

* Safety and Efficacy of Once Daily 220 mg Dabigatran Etexilate in a Real-World Non-Interventional Study of More Than 5000 Patients After Total Knee or Hip Replacement. Lead Author: N. Rosencher, Poster No. 10001

† The most common risk factors identified in the study included chronic use of NSAIDs, active smoking, concomitant ASA use, and coronary artery disease.

References

1. Rosencher N. et al. Safety and efficacy of once daily 220 mg dabigatran etexilate in a real-world noninterventional study of more than 5000 patients after total knee or hip replacement. Poster Presentation 10001. Presented on 5 November 2012 at the American Heart Association Scientific Sessions 2012.
2. Hawkins D. The role of oral direct thrombin inhibitors in the prophylaxis of venous thromboembolism. Pharmacotherapy. 2004;24:179S–83S.
3.Tilleul P. et al. Estimated annual costs of prophylaxis and treatment of venous thromboembolic events associated with major orthopedic surgery in France. Clin Appl Thromb Hemost. 2006;12:473-84.
4. Cohen AT, Agnelli G, Anderson FA et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost. 2007;98:756–64.
5. Brandjes D, Heijboer H, Buller H, et al. Acenocoumarol and heparin compared with acenocoumarol alone in the initial treatment of proximal-vein thrombosis. NEJM. 1992;327:1485–9.
6. Eriksson BI, et al. Oral Dabigatran etexilate vs.subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost. 2007;5(11),2178–85.
7. Eriksson BI, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trialLancet 2007;370 (9591),949–56.
8.Eriksson BI, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II). Thromb Haemost. 2011;105(4),72–9.
9. Boehringer Ingelhem data on file.
10. White RH.The epidemiology of venous thromboembolism. Circulation. 2003;107[23 suppl 1]:I4-I8.
11. Hansson PO, et al. Recurrent venous thromboembolism after deep vein thrombosis: incidence and risk factors. Arch Intern Med 2000;160:769–74.
12. Pengo V, et al. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. NEJM. 2004;350:2257-64.
13. Dobesh PP. Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy. 2009;29:943–53.
14. Di Nisio M, et al. Direct thrombin inhibitors. NEJM. 2005;353:1028-40.

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