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06 November 2012 at 12:49 - Posted by AfricaFinance

Safety and Efficacy of Pradaxa® (dabigatran etexilate) Reconfirmed in Clinical Setting for VTE Prevention After Total Knee or Hip Replacement


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INGELHEIM, Germany - Tuesday, November 6th 2012 [ME NewsWire]

- 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

(BUSINESS WIRE)-- 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 stroke.2 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.

*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.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/06_november_2012_dabigatran_etexilate.html

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